Archive for the ‘Genetic Testing’ Category

LEAH Messers daughter Ali Simms had a long road of tests and procedures to diagnose her with muscular dystrophy, leaving the Teen Mom 2 star with unbearable pain.

Leah, 27, detailed Alis struggle with muscular dystrophy, a genetic disease that causes weakness and loss of muscle mass, in her memoir, Hope, Grace & Faith, which is out May 5.

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The MTV star wrote that she knew the moment Ali was born that there was something more going on than what doctors told her and baby daddy Corey Simms.

During her C-section, Corey asked about his newborn daughter: Whats wrong with her? There something wrong with her legs.

Leah explained how Alis legs were stuck up over her head and her hands were hyperextended back towards her elbows.

Leah was told this was fairly common among breech babies and that was likely her position as the bottom baby in the womb.

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She explained how while twin sister Aleeah was reaching developmental milestones, Ali, now 10, just didnt seem to have the strength.

The older Ali got, the more she kept falling further and further behind.

By her first birthday, she couldnt bear any weight on her legs.

Leah wrote: For the first three years of Alis life, I felt like I was holding my breath. She was tested for everything from a spinal injury to skeletal and neuromuscular disorders.

"We met with so many different specialists it made our heads spingeneticists, neurologists, orthopedists, and neuromuscular specialists."

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She said her daughter underwent X-rays, bloodwork, genetic testing, muscle biopsies and multiple MRIs.

The reality star wrote: My maternal instinct was screaming that there was more going on with her than just a developmental delay, but none of the doctors we took her to seemed to be able to tell me why she wasnt reaching those early milestones.

She claimed one doctor, without any testing, thought she could have dwarfism, down syndrome or spina bifida.

Leah explained how the road to finding a diagnosis was long and lonely, as family, including Corey, insisted she stop putting Ali through testing.

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But after Dr. Tsao, who has appeared on Teen Mom 2, gave Ali a muscle biopsy, he diagnosed her with Titin Myopathy.

She explained in the book: At the time, there were only a handful of adults around the world with the same type of muscular dystrophy, and Ali was the first child ever to be diagnosed.

"With adults, they know that Titin MD can lead to heart and lung failure, but for Ali, we have no idea what to expect as she gets older because she is the research.

Leah, who is also mom to daughter Adalynn with ex-husband Jeremy Calvert, called the process to get the diagnosis unbearable, and she was angry that there is no cure.

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She wrote: Every time we had to have Ali tested, it was like having our hearts ripped out of our bodies, especially when she had to be sedated for the MRIs and the muscle biopsy. In those first few years of her life, I just remember feeling helpless all the time."

Leah explained how Aleeah began acting out, as their focus was on Ali.

She would throw fits, hit and be mean to Ali.

The twins are doing a lot better now, it is still a daily struggle for both of them.

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She wrote: "I worry all the time that theyre not as close as other twins because of everything they have to go through.

Ali will see her sister running and doing all the things I have to hold her back from (for her own safe-ty), which is so hard on her. At the same time, Aleeah sees me spending all this time with Ali, taking her to physical therapy and driving to all her doctors appointments, which can leave her feeling left out and neglected.

Leah said all she could do is try to find a balance where they know they are loved.

As The Sun exclusively reported, Leah also revealed her suicide attempt by driving off a cliff, her sexual abuse as a child, her abortion secret and her battle with drug use in the memoir.

Do you have a story for The US Sun team?

Email us at exclusive@the-sun.com or call 212 416 4552.

Like us on Facebook at http://www.facebook.com/TheSunUS and follow us from our main Twitter account at @TheSunUS.

Originally posted here:
Teen Mom Leah Messer says daughter Alis road to muscular dystrophy diagnosis was lonely and the pain was u - The Sun

The Most Recent study on the Preimplantation Genetic Testing Market Research provides a profound comprehension of the various market dynamics like trends, drivers, the challenges, and opportunities. The report further elaborates on the micro and macro-economic elements that are predicted to shape the increase of the Preimplantation Genetic Testing market throughout the forecast period (2019-2029).

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Preimplantation Genetic Testing Market Segmentation Assessment

The increase prospects of this market in various Regions are studied in the report together with details like the regulatory framework, political, and financial outlook of each region.

Competition Tracking

The report also profiles companies operating in the preimplantation genetic testing market, which include Agilent Technologies Inc., Abbott Laboratories, CooperSurgical Inc., Oxford Gene Technology IP, Illumina, Inc., Thermo Fisher Scientific, Inc., PerkinElmer, Inc., Genea Limited, Natera, Inc., Rubicon Genomics, Inc., and CombiMatrix Corporation.

Note: The insights mentioned here are of the respective analysts, and do not reflect the position of Fact.MR

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Preimplantation Genetic Testing Market: Study provides in-depth analysis of market along with the current trends and future estimations (2019 2025) -...

Los Angeles, United States, April, 2020, The new report has been added by qyresearch.com to provide detailed insight into the global Direct-To-Consumer (DTC) Genetic Testing market. The study will help to get a better understanding about the Direct-To-Consumer (DTC) Genetic Testing industry competitors, a channel for the distribution, Direct-To-Consumer (DTC) Genetic Testing growth potential, potentially disruptive trends, Direct-To-Consumer (DTC) Genetic Testing industry product innovations, market size value/volume (regional/country level, Direct-To-Consumer (DTC) Genetic Testing industry segments), market share of top players/products.

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Direct-To-Consumer (DTC) Genetic Testing Market which would mention How the COVID-19 is Affecting the Direct-To-Consumer (DTC) Genetic Testing Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, COVID-19 Impact on Key Regions and Proposal for Direct-To-Consumer (DTC) Genetic Testing Players to Combat COVID-19 Impact.

QY Research has acquired great experience in market research and has been producing reports offering critical analysis of various markets with quality and accuracy. Our market analysts utilize various research methodologies to offer precise and reliable information to the market players to effectively design new growth strategies with an aim to strengthen their presence in the market. They also provide various SWOT and PESTLE analyses that act as a useful tool for the market participants to evaluate different scenarios of the concerned market and take further decision.

The insight has been added in the report to provide realistic overview of the industry, consist of Direct-To-Consumer (DTC) Genetic Testing manufacturers data, i.e. shipment, price, revenue, gross profit, business distribution, etc., SWOT analysis, consumer preference, recent developments and trends, drivers and restrain factors, company profile, investment opportunity, demand gap analysis, forecast market size value/volume, services and product, Porters Five Models, socioeconomic factors, government regulation in Direct-To-Consumer (DTC) Genetic Testing industry. Market players can use the report to peep into the future of the global Direct-To-Consumer (DTC) Genetic Testing market and bring important changes to their operating style and marketing tactics to achieve sustained growth.

Download Sample Copy of Direct-To-Consumer (DTC) Genetic Testing Market Report Study 2019-2026 At: https://www.qyresearch.com/sample-form/form/1639883/global-direct-to-consumer-dtc-genetic-testing-market

The report reviews the competitive landscape scenario seen among top Direct-To-Consumer (DTC) Genetic Testing Sales players, their company profile, revenue, sales, business tactics and forecast Direct-To-Consumer (DTC) Genetic Testing Sales industry situations. According to the research, Direct-To-Consumer (DTC) Genetic Testing Sales market is highly competing and disparate due to global and local vendors. The global Direct-To-Consumer (DTC) Genetic Testing Sales market report chiefly includes following manufacturers-

Keyplayers:AncestryColor GenomicsEasy DNAFamilytreeDNA (Gene By Gene)Full Genome CorporationHelix OpCo LLCIdentigeneKarmagenesLiving DNAMapmygenomeMyHeritagePathway GenomicsGenesis Healthcare23andMe

Types:Carrier TestingPredictive TestingAncestry & Relationship TestingNutrigenomics TestingOthers

Applications:Online PlatformsOver-the-Counter

Market Competition

The competitive landscape of the global Direct-To-Consumer (DTC) Genetic Testing market is broadly studied in the report with large focus on recent developments, future plans of top players, and key growth strategies adopted by them. The analysts authoring the report have profiled almost every major player of the global Direct-To-Consumer (DTC) Genetic Testing market and thrown light on their crucial business aspects such as production, areas of operation, and product portfolio. All companies analyzed in the report are studied on the basis of important factors such as market share, market growth, company size, output, sales and income.

Highlights of Report

Distribution channel assessment

Innovation trends

Sustainability strategies

Niche market trends

Market entry analysis

Market sizing and forecasts

The geographical division offers data that gives you an idea of the revenue of the companies and sales figures of the Direct-To-Consumer (DTC) Genetic Testing For Electrical Meters growth business. Here are highlights of the Geographical divisions: North America (United Statess, Canada and Mexico), Europe (Germany, Spain, France, UK, Russia and Italy and more), Asia-Pacific (China, Japan, Korea, India and Southeast Asia and more), South America (Brazil, Argentina, Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa) and ROW.

Table of Content

Market Overview: This is the first section of the report that includes an overview of the scope of products offered in the global Direct-To-Consumer (DTC) Genetic Testing market, segments by product and application, and market size.

Market Competition by Player: Here, the report shows how the competition in the global Direct-To-Consumer (DTC) Genetic Testing market is growing or decreasing based on deep analysis of market concentrate rate, competitive situations and trends, expansions, merger and acquisition deals, and other subjects. It also shows how different companies are progressing in the global Direct-To-Consumer (DTC) Genetic Testing market in terms of revenue, production, sales, and market share.

Company Profiles and Sales Data: This part of the report is very important as it gives statistical as well as other types of analysis of leading manufacturers in the global Direct-To-Consumer (DTC) Genetic Testing market. It assesses each and every player studied in the report on the basis of the main business, gross margin, revenue, sales, price, competitors, manufacturing base, product specification, product application, and product category.

Market by Product: This section carefully analyzes all product segments of the global Direct-To-Consumer (DTC) Genetic Testing market.

Market by Application: Here, various application segments of the global Direct-To-Consumer (DTC) Genetic Testing market are taken into account for the research study.

Market Forecast: It starts with revenue forecast and then continues with sales, sales growth rate, and revenue growth rate forecasts of the global Direct-To-Consumer (DTC) Genetic Testing market. The forecasts are also provided taking into consideration product, application, and regional segments of the global Direct-To-Consumer (DTC) Genetic Testing market.

Upstream Raw Materials: This section includes industrial chain analysis, manufacturing cost structure analysis, and key raw materials analysis of the global Direct-To-Consumer (DTC) Genetic Testing market.

Marketing Strategy Analysis, Distributors: Here, the research study digs deep into behavior and other factors of downstream customers, distributors, development trends of marketing channels, and marketing channels such as indirect marketing and direct marketing.

Research Findings and Conclusion: This section is solely dedicated to the conclusion and findings of the research study on the global Direct-To-Consumer (DTC) Genetic Testing market.

For Further Detailed insights and Any Query About Direct-To-Consumer (DTC) Genetic Testing Market, Place your Query Here!- https://www.qyresearch.com/customize-request/form/1639883/global-direct-to-consumer-dtc-genetic-testing-market

The report answers important questions that companies may have when operating in the global Direct-To-Consumer (DTC) Genetic Testing market. Some of the questions are given below:

What will be the size of the global Direct-To-Consumer (DTC) Genetic Testing market in 2025?

What is the current CAGR of the global Direct-To-Consumer (DTC) Genetic Testing market?

What products have the highest growth rates?

Which application is projected to gain a lions share of the global Direct-To-Consumer (DTC) Genetic Testing market?

Which region is foretold to create the most number of opportunities in the global Direct-To-Consumer (DTC) Genetic Testing market?

Which are the top players currently operating in the global Direct-To-Consumer (DTC) Genetic Testing market?

How will the market situation change over the next few years?

What are the common business tactics adopted by players?

What is the growth outlook of the global Direct-To-Consumer (DTC) Genetic Testing market?

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QY Research established in 2007, focus on custom research, management consulting, IPO consulting, industry chain research, data base and seminar services. The company owned a large basic data base (such as National Bureau of statistics database, Customs import and export database, Industry Association Database etc), experts resources (included energy automotive chemical medical ICT consumer goods etc.

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Direct-To-Consumer (DTC) Genetic Testing Market Analysis 2020 Growth by Top Companies and Trends by Types, Treatment, Diagnosis and Application ...

Even before Texas first case of the novel coronavirus landed in March in Fort Bend County, Mrudula Rakhade was preparing how her clinical laboratory in a northwest Houston business park could accommodate the testing to come.

Anticipating the need in February to test for the rapidly-spreading virus back when international travel was the leading source Rakhade took the lead in ordering COVID-19 supplies for Altru Diagnostics, where she works as the chief scientific officer. She also made the lab one of the few statewide to be registered with the U.S. Food and Drug Administration to identify positive traces of the virus.

By the time her boss of two years, Dr. Jesse Howard, suggested the lab take on COVID-19 testing in March she had news for him.

I told him, Youre going to get COVID testing in a week because I had already been working on it, Rakhade proudly said.

As Howard, who opened the lab with his late father in 2016, walked by her office Monday afternoon, he said I trust her blindly.

CORONAVIRUS UPDATES: Stay informed with accurate reporting you can trust

Now, the 25-employee operation off the Katy Freeway is analyzing more than 1,000 specimens a day, mostly for local medical providers, including four United Memorial Medical Center drive thru-testing sites. Increases in testing have doubled the number of specimens they started with on March 19. Since then, they have analyzed an estimated 20,000 tests or more, Howard said.

Rakhade and her team of molecular technologists are pulling 12-hour shifts in cramped rooms to meet the growing demand. Social distancing is not an option. Some workers wear N-95 masks, while others, like Rakhade, choose at times not to.

I havent gotten anything yet, she said, adding that employees are tested every week for the novel coronavirus out of precaution. We dont go and touch anything without gloves on.

A meticulous assembly line starts the moment a courier arrives and couriers with coolers packed with tests routinely pop into the lab.

Specimens are packed into one-time use plastic plates designed to hold 96 biological samples which are then injected with a magnetic solution to isolate any trace of the coronavirus ribonucleic acid, also known as RNA.

Another machine identifies how much novel coronavirus if any is in a sample, using a predetermined range for a positive result. A lower range of a positive could mean the nasal swab was not administered properly.

Some people dont go that deep, she said.

Undetermined values mean the sample is negative.

For each batch, the process can take up to four hours. As of Monday, the turnaround time, which includes contacting patients with their results, can be anywhere from 24 to 48 hours.

It is difficult to fulfill everyones expectations at this point, she continued.

And then the patients themselves start calling.

We just have to be patient with them, Rakhade said. Sometimes they get frustrated wondering why their results are not yet in. What can I do, they ask. Im quarantined.

CORONAVIRUS IN HOUSTON: All of the latest news, numbers and analysis to keep you up-to-date, only on HoustonChronicle.com

On Sunday, for the first time in a month, Rakhade took the day off.

Up until then, she had spent several sleepless nights at the lab. She worked exhaustively in mid-March to finalize their COVID-19 certification with a positive patient sample supplied by the Centers for Disease Control to base their review.

I stayed up two nights continuously getting that done, Rakhade said. The night before I finished, we went home around 2 a.m. and I came back at 6 a.m. to finish.

During their research for certification, the lab stumbled across what appeared to be Laredos first case, she said. Without federal registration, which she finalized on March 18, the lab was unable to consider it official and recommended the patient an elementary school teacher be retested. According to Laredo officials, the San Antonio Metro Laboratory handled her test and her case was confirmed on March 17. Two days later, Altru Diagnostics first official positive arrived amid an estimated batch of 500 samples. That lone specimen was followed by about three more positives.

It was very rare to see a positive. It had just started, Rakhade said. After that it became routine because we had been testing so many samples.

Despite all her preparation, the lab ran into a similar problem plaguing hospitals and the Houston and Harris County-operated drive-thru testing sites: supply shortages.

On Friday, the lab used up all its plastic plates designed to hold COVID-19 samples. The plates can only be used once and the manufacturer was also out.

Rakhade resorted to old-school bartering to get what they needed. Another lab in Houston, which does not do COVID-19 testing, had a stash of unused plates. And she had what they needed micro fluiditcs chips for genetic testing.

All the manufacturers are focusing on COVID-19 supplies, she said. They needed something they couldnt get because its not COVID-19.

nicole.hensley@chron.com

See the article here:
Inside the Houston lab tackling thousands of COVID-19 tests - msnNOW

Global Genetic Testing for Consumers (DTC) Market Size, Status and Forecast 2020-2026

In 2019, the global Genetic Testing for Consumers (DTC) market size was US$ xx million and it is expected to reach US$ xx million by the end of 2026, with a CAGR of xx% during 2021-2026.

Genetic Testing for Consumers (DTC) market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Genetic Testing for Consumers (DTC) market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2015-2026.The Report scope furnishes with vital statistics about the current market status and manufacturers. It analyzes the in-depth business by considering different aspects, direction for companies, and strategy in the industry.

After analyzing the report and all the aspects of the new investment projects, it is assessed the overall research and closure offered. The analysis of each segment in-detailed with various point views; that include the availability of data, facts, and figures, past performance, trends, and way of approaching in the market. The Genetic Testing for Consumers (DTC) Market report also covers the in-depth analysis of the market dynamics, price, and forecast parameters which also include the demand, profit margin, supply and cost for the industry.

The report additionally provides a pest analysis of all five along with the SWOT analysis for all companies profiled in the report. The report also consists of various company profiles and their key players; it also includes the competitive scenario, opportunities, and market of geographic regions. The regional outlook on the Genetic Testing for Consumers (DTC) market covers areas such as Europe, Asia, China, India, North America, and the rest of the globe.

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Top key players @ Mapmygenome, Karmagenes, Helix OpCo LLC, Full Genome Corporation, FamilytreeDNA (Gene By Gene), Easy DNA, Color Genomics, MyHeritage, Living DNA, Identigene, Ancestry, 23andMe, Pathway Genomics, and Genesis Healthcare

The main goal for the dissemination of this information is to give a descriptive analysis of how the trends could potentially affect the upcoming future of Genetic Testing for Consumers (DTC) market during the forecast period. This markets competitive manufactures and the upcoming manufactures are studied with their detailed research. Revenue, production, price, market share of these players is mentioned with precise information.

Global Genetic Testing for Consumers (DTC) Market: Regional Segment Analysis

This report provides pinpoint analysis for changing competitive dynamics. It offers a forward-looking perspective on different factors driving or limiting market growth. It provides a five-year forecast assessed on the basis of how they Genetic Testing for Consumers (DTC) Market is predicted to grow. It helps in understanding the key product segments and their future and helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments.

Key questions answered in the report include:

What will the market size and the growth rate be in 2026?

What are the key factors driving the Global Genetic Testing for Consumers (DTC) Market?

What are the key market trends impacting the growth of the Global Genetic Testing for Consumers (DTC) Market?

What are the challenges to market growth?

Who are the key vendors in the Global Genetic Testing for Consumers (DTC) Market?

What are the market opportunities and threats faced by the vendors in the Global Genetic Testing for Consumers (DTC) Market?

Trending factors influencing the market shares of the Americas, APAC, Europe, and MEA.

The report includes six parts, dealing with:

1.) Basic information;

2.) The Asia Genetic Testing for Consumers (DTC) Market;

3.) The North American Genetic Testing for Consumers (DTC) Market;

4.) The European Genetic Testing for Consumers (DTC) Market;

5.) Market entry and investment feasibility;

6.) The report conclusion.

All the research report is made by using two techniques that are Primary and secondary research. There are various dynamic features of the business, like client need and feedback from the customers. Before (company name) curate any report, it has studied in-depth from all dynamic aspects such as industrial structure, application, classification, and definition.

The report focuses on some very essential points and gives a piece of full information about Revenue, production, price, and market share.

Genetic Testing for Consumers (DTC) Market report will enlist all sections and research for each and every point without showing any indeterminate of the company.

Reasons for Buying this Report

This report provides pin-point analysis for changing competitive dynamics

It provides a forward looking perspective on different factors driving or restraining market growth

It provides a six-year forecast assessed on the basis of how the market is predicted to grow

It helps in understanding the key product segments and their future

It provides pin point analysis of changing competition dynamics and keeps you ahead of competitors

It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

TABLE OF CONTENT:

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 United States

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2019-2025

14 Analysts Viewpoints/Conclusions

15 Appendix

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Global Genetic Testing for Consumers (DTC) Market Size Industry Research Report, Growth Trends and Competitive Analysis 2020-2025 - Science In Me

The Predictive Genetic Testing market report aims to offer an extensive overview of the market with broad segmentation on the basis of products, services, application, as well as regional overview. In addition, the Predictive Genetic Testing market report also provides a complete analysis of the global market trends that are influencing the global market over the forecast period. Moreover, the global Predictive Genetic Testing market is likely to witness a significant growth over the forecast period.

Top Leading Key Players are: Agilent, Technologies, Inc., BGI Genomics, F.Hoffman-La Roche Ltd., Genes In Life., Invitae Corporation, Illumina, Inc., 23andMe, Myriad Genetics, Inc., Pathway Genomics and Thermo Fisher Scientific, Inc.

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In addition to this, the Predictive Genetic Testing market report also provides helpful insights for every established and innovative players across the globe. Furthermore the Predictive Genetic Testing market report offers accurate analysis for the shifting competitive dynamics. This research report comprises a complete analysis of future growth in terms of the evaluation of the mentioned forecast period. The Predictive Genetic Testing market report offers a comprehensive study of the technological growth outlook over time to know the market growth rates. The market report also includes progressive analysis of the huge number of different factors that are boosting or operating as well as regulating the market growth.

The Predictive Genetic Testing market report also gives a key statistics depending on the market status and it also provides major market trends as well as opportunities in the global market. In addition, the global Predictive Genetic Testing market report also emphasizes on the major market service providers with data such as product and services, company profiles, financial data of previous years, and key development in past years. Furthermore, the market report also provides the detailed information which has been analysed on the basis of upcoming competitors and the existing leading players. Moreover, the Predictive Genetic Testing market report is an intelligence report with the significant efforts undertaken to analyse the valuable as well as right information. Additionally, the market report also studies a complete assessment of the aspects that are anticipated to influence the growth of the market.

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The company profile section also focusses on companies planning expansions along with mergers & acquisitions, new initiatives, R&D updates and financial updates. But, one of the most important aspects focused in this study is the regional analysis. Region segmentation of Predictive Genetic Testing market helps in detailed analysis of the market in terms of business opportunities, revenue generation potential and future predictions of the market. For Predictive Genetic Testing market report, the important regions highlighted are North America, South America, Asia, Europe and Middle East. The companies focused on in this report are pioneers in the Predictive Genetic Testing market. Right from history to future plans the report give a detailed roadmap of the industry that the readers can rely on. The uplifting of any region in the global market is dependent upon the market players working in that region.

The report is rightly designed to present multidimensional information about the current and past market occurrences that tend to have a direct implication on onward growth trajectory of the Predictive Genetic Testing market. The report specifically focuses on market drivers, challenges, threats, and the like that closely manifest market revenue cycle to encourage optimum profit generation in the Predictive Genetic Testing market.

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Global Predictive Genetic Testing Market 2020: Development Trends, Application, Capabilities and Technologies, Expert's Analysis & Competitive...

The Direct-to-consumer Genetic Testing market report from eSherpa Market Reports includes detailed information on competition like the market size, share and company profiles of key players operating in the global market. The report provides a bigger picture of the Direct-to-consumer Genetic Testing market considering the global scenario and also offers a forecast and data in terms of revenue in the mentioned period. Further, it studies the opportunities and a wide picture of top players involved in the Direct-to-consumer Genetic Testing market. The market is estimated to grow at a CAGR of XX% and it has stated various growth opportunities in every section including sub-segments and their market size and share.

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This Report Covers Leading Companies Associated in Worldwide Direct-to-consumer Genetic Testing Market:

23andMe, MyHeritage, LabCorp, Myriad Genetics, Ancestry.com, Quest Diagnostics, Gene By Gene, DNA Diagnostics Center, Invitae, IntelliGenetics, Ambry Genetics, Living DNA, EasyDNA, Pathway Genomics, Centrillion Technology, Xcode, Color Genomics, Anglia DNA Services, African Ancestry, Canadian DNA Services, DNA Family Check, Alpha Biolaboratories, Test Me DNA, 23 Mofang, Genetic Health, DNA Services of America, Shuwen Health Sciences, Mapmygenome, Full Genomes

Key Businesses Segmentation of Direct-to-consumer Genetic Testing Market:

Global Direct-to-consumer Genetic Testing Market Segment by Type, covers

Global Direct-to-consumer Genetic Testing Market Segment by Applications, can be divided into

Direct-to-consumer Genetic Testing Market Report Covers Following Questions

What are the weaknesses and strengths of the key vendors?What are the key outcomes of the five forces analysis of the Global Direct-to-consumer Genetic Testing market?What are the various threats and opportunities faced by the dealers in the Global Direct-to-consumer Genetic Testing market?Who are the leading key players and what are their key business strategies in the Global Direct-to-consumer Genetic Testing market?

Table of Contents

Section 1 Direct-to-consumer Genetic Testing Product Definition

Section 2 Global Direct-to-consumer Genetic Testing Market Manufacturer Share and Market Overview

2.1 Global Manufacturer Direct-to-consumer Genetic Testing Shipments

2.2 Global Manufacturer Direct-to-consumer Genetic Testing Business Revenue

2.3 Global Direct-to-consumer Genetic Testing Market Overview

Section 3 Manufacturer Direct-to-consumer Genetic Testing Business Introduction

Section 4 Global Direct-to-consumer Genetic Testing Market Segmentation (Region Level)

Section 5 Global Direct-to-consumer Genetic Testing Market Segmentation (Product Type Level)

5.1 Global Direct-to-consumer Genetic Testing Market Segmentation (Product Type Level) Market Size 2014-2019

5.2 Different Direct-to-consumer Genetic Testing Product Type Price 2014-2019

5.3 Global Direct-to-consumer Genetic Testing Market Segmentation (Product Type Level) Analysis

Section 6 Global Direct-to-consumer Genetic Testing Market Segmentation (Industry Level)

6.1 Global Direct-to-consumer Genetic Testing Market Segmentation (Industry Level) Market Size 2014-2019

6.2 Different Industry Price 2014-2019

6.3 Global Direct-to-consumer Genetic Testing Market Segmentation (Industry Level) Analysis

Section 7 Global Direct-to-consumer Genetic Testing Market Segmentation (Channel Level)

7.1 Global Direct-to-consumer Genetic Testing Market Segmentation (Channel Level) Sales Volume and Share 2014-2019

7.2 Global Direct-to-consumer Genetic Testing Market Segmentation (Channel Level) Analysis

Section 8 Direct-to-consumer Genetic Testing Market Forecast 2019-2024

8.1 Direct-to-consumer Genetic Testing Segmentation Market Forecast (Region Level)

8.2 Direct-to-consumer Genetic Testing Segmentation Market Forecast (Product Type Level)

8.3 Direct-to-consumer Genetic Testing Segmentation Market Forecast (Industry Level)

8.4 Direct-to-consumer Genetic Testing Segmentation Market Forecast (Channel Level)

Section 9 Direct-to-consumer Genetic Testing Segmentation Product Type

Section 10 Direct-to-consumer Genetic Testing Segmentation Industry

Section 11 Direct-to-consumer Genetic Testing Cost of Production Analysis

11.1 Raw Material Cost Analysis

11.2 Technology Cost Analysis

11.3 Labor Cost Analysis

11.4 Cost Overview

. And More

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Direct-to-consumer Genetic Testing Market Trends and Opportunities by types and Application in Grooming Regions; Edition 2020-2024 - Science In Me

Global Genetic Testing Market Status and Future Forecast 2015-2025, Key Regions, Types and Application, By Players, Type, Application, Marketing Channel and Region

This report focuses on the Genetic Testing Market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Genetic Testing Market development in United States, Europe and China.

In 2019, the Genetic Testing Market size was million US$ and it is expected to reach million US$ by the end of 2025, with a CAGR of during 2020-2025.

The report also summarizes the various types of the Genetic Testing Market. Factors that influence the market growth of particular product category type and market status for it. A detailed study of the Genetic Testing Market has been done to understand the various applications of the products usage and features. Readers looking for scope of growth with respect to product categories can get all the desired information over here, along with supporting figures and facts.

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Top Key Players: GeneDx, Invitae, Pathway Genomics, Counsyl Inc, Asper Biotech, GenePlanet, Courtagen Life Sciences, Gene By Gene, Natera Inc, Regulatory, GeneTests, United Gene, HI Gene, Berry Genomics, 23andMe Inc, 360Jiyin, Novogene, CapitalBio, Agen, Biomedlab, Biomarker, Annoroad, Aiyin Gene, Aijiyin, Repconex, Find Bio-Tech, SinoGenoMax, Gene Kang, Geeppine, and BGI

This report provides pinpoint analysis for changing competitive dynamics. It offers a forward-looking perspective on different factors driving or limiting market growth. It provides a five-year forecast assessed on the basis of how they Genetic Testing Market is predicted to grow. It helps in understanding the key product segments and their future and helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments.

Key questions answered in the report include:

What will the market size and the growth rate be in 2026?

What are the key factors driving the Genetic Testing Market?

What are the key market trends impacting the growth of the Genetic Testing Market?

What are the challenges to market growth?

Who are the key vendors in the Genetic Testing Market?

What are the market opportunities and threats faced by the vendors in the Genetic Testing Market?

Trending factors influencing the market shares of the Americas, APAC, Europe, and MEA.

The report includes six parts, dealing with:

1.) Basic information;

2.) The Asia Genetic Testing Market;

3.) The North American Genetic Testing Market;

4.) The European Genetic Testing Market;

5.) Market entry and investment feasibility;

6.) The report conclusion.

All the research report is made by using two techniques that are Primary and secondary research. There are various dynamic features of the business, like client need and feedback from the customers. Before (company name) curate any report, it has studied in-depth from all dynamic aspects such as industrial structure, application, classification, and definition.

The report focuses on some very essential points and gives a piece of full information about Revenue, production, price, and market share.

Genetic Testing Market report will enlist all sections and research for each and every point without showing any indeterminate of the company.

Reasons for Buying this Report

This report provides pin-point analysis for changing competitive dynamics

It provides a forward looking perspective on different factors driving or restraining market growth

It provides a six-year forecast assessed on the basis of how the market is predicted to grow

It helps in understanding the key product segments and their future

It provides pin point analysis of changing competition dynamics and keeps you ahead of competitors

It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

TABLE OF CONTENT:

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 United States

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2020-2026

14 Analysts Viewpoints/Conclusions

15 Appendix

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Global Genetic Testing Market Status and Future Forecast 2015-2025, Key Regions, Types and Application, By Players, Type, Application, Marketing...

By David Gress

Perhaps the first thing you notice about a Lemon-Scented Gum tree is its unique bark - pinkish-white and perfectly smooth. A real eye-catcher.

For quick identification, other striking features are its long trunk and, topping that, the up-reaching open branch structure with graceful pendulous branchlets, all of which make a beautiful silhouette against the sky. Its hard to miss a mature tree, since it can easily reach over 100 feet in height with a crown spread of over 90 feet in width!

The best way to remember the first part of its common name is to pick a leaf, crush it between your fingers, sniff its broken margins, and instantly experience its refreshing lemon scent - a delightful dose of aromatherapy! Gum refers to the fact that sap oozing from any wounds in the bark is quite gummy and sticky.

The Lemon-Scented Gum is native to the dry woodlands of Queensland, Australia. It was brought to California in the late 1880s - and was first planted locally by Ellwood Cooper in 1887 at his ranch west of Goleta (part of which is now the Ellwood Preserve). One of his trees has grown to be the largest of its kind in California - with a height exceeding 140 feet, a crown spread of over 95 feet, and a trunk nearly 14 feet in circumference! Early in the last century, it was crowned the Ellwood Queen and today, at age 133, it still stands as a truly regal specimen.

Mature leaves are glossy green on both sides and measure and 1/3 to 1 inch wide and 3 to 6 inches long; these are often sickle-shaped. Curiously, juvenile leaves are larger, at 1 to 3 inches wide and 4 to 7 inches long; these can be rough and bristly from long oil glands and, as a result, are the most strongly scented.

Through late winter and spring, its small white flowers appear in dense clusters along the branchlets. The fuzzy-looking flowers offer copious amounts of pollen and nectar, which are very attractive to bees who, not surprisingly, make from them a delicious honey. The pollinated flowers develop into woody, urn-shaped capsules, inch long, which are filled with tiny seeds.

Currently, there are no serious insect or disease problems with this tree species. In the not-too-distant past, though, it did suffer from invasion by a serious insect pest, the lerp psyllid, a bug as nasty as its name sounds. Fortunately, this psyllid seems to have been controlled through the release of great numbers of a parasitic wasp, a natural predator. Biological warfare at its best!

Lemon-Scented Gum is very well suited to our Mediterranean climate. It can grow in a wide variety of soil conditions and is quite drought-tolerant when established. Due also to its elegant and graceful appearance, it has proved to be very popular. Consequently, over the years, it has been planted extensively, as an ornamental tree, throughout Santa Barbara County and California.

Besides its value as a landscape tree, the Lemon-Scented Gum has many useful purposes. The leaves and sap contain the chemical citronellal, which is processed into essential citronella oils used in perfumes, menthols, insect repellents, and aboriginal and traditional medicines. In Australian, its wood is highly prized for tools and lumber.

Its botanical name is Corymbia citriodora. The genus name, Corymbia, refers to its corymb-type flower clusters. The specific epithet, citriodora, refers to its lemon-citrus odor. Most folks think Lemon-Scented Gum is still in the genus Eucalyptus; but, its only a close relative. After genetic testing, it was reclassified into the genus Corymbia.

Because of its potentially large size at maturity, a Lemon-Scented Gum should be placed in a location that can accommodate its ultimate growth. It should be planted in a sunny location. Note: a young tree will require adequate staking, to allow the trunk and roots to sufficiently develop before the tree is subject to buffeting winds.

Besides the Ellwood Queen, there are several well-known and historic Lemon-Scented Gums in Santa Barbara. The oldest and largest, the Fernald Eucalyptus, standing on the east side of the 400 block of Santa Barbara Street, was saved by Pearl Chase when that block was being developed. The old trees in front of the Central Library downtown have been designated historic landmarks by the City. Other outstanding specimens can be seen on upper State Street at Calle Real, in the parking lot of 5 Points Shopping Center, on State Street near Ontare Road and near Hope Avenue, and on Santa Barbara Street at Haley Street.

Tree-of-the-Month articles are sponsored by Santa Barbara Beautiful, whose many missions include the increase of public awareness and appreciation of Santa Barbaras many outstanding trees and, in a long-time partnership with the City Parks & Recreation Department, the funding and planting of trees along the Citys streets a project which has resulted in the planting, to date, of more than 12,000 street trees

See the article here:
April Tree of the Month: Lemon-Scented Gum - Santa Barbara Edhat

In the midst of the current coronavirus pandemic, companies that offer virtual appointments are seeing a rise in usage. With the population self-isolating and staying indoors and with many doctors offices closing, virtual appointments have become crucial to addressing all emerging health concerns. Its not just about speaking with a doctor though, its about providing patients with the best possible care from afar to prevent any potential spread of COVID-19.

Digitization has allowed these types of meetings to become a realityit has opened the door for highly tailored and precise healthcare.

Artificial intelligence, blockchain, and 5G connectivity are all assisting in pushing healthcares move into the futuresomething like this wasnt available 5-10 years ago.

Additionally, options like DNA profiling have also expanded the universe of big data that clinicians can mine in search of the right treatments for their patients. And that universe is getting bigger all the time MIT Technology review estimates more than 26 million people have taken a DNA ancestry test in the U.S. alone.

And people arent just getting ancestry data with their profiles. In some cases, theyre also getting specific medical information on their predisposition to certain diseases. Many patients are also taking advantage of the convenience of telemedicine to get health advice on their data.

Coinciding with the explosion in digitized medicine is the equally rapid emergence of the hemp-based CBD market. And with health and wellness becoming more of a priority than ever, health practitioners, along with patients, are searching for more natural holistic health alternatives.

As such, the current market volatility hasnt stopped Empower Clinics Inc (CSE: CBDT, OTC: EPWCF, FRA: 8EC) from operating and expanding on its service offering. The companys clinics remain in high demandpatient visits in corporate clinics are continuing at a record pace, with patients demonstrating an even greater need for plant-based holistic medicine, as the impact of COVID-19 becomes more pervasive.

Medical cannabis certifications are considered an essential service during this time, and Steve McAuley, CEO of Empower Clinics, notes that the companys clinics remain incredibly busy.

We had to quickly adapt clinic operating procedures to ensure optimum safety for employees and patients, updating cleaning and sanitation protocols, and providing extensive new communications to our team and patients.

With cannabis being a crucial part of treatment regimensfor thousands, Empower is proud to continue providing their consumers with medical cannabis treatment options.

So, with all of this in mind, the company is betting that telemedicine, along with DNA testing, will go a long way in helping consumers choose the right CBD product for their ailments and genetic profile.

Steve McAuley, CEO, Empower Clinics Inc.

Precise treatment through genetic testing

As a vertically integrated CBD life sciences company, Empower is level-set on helping patients get scientific with their choice of CBD products. The company recently established a crucial partnership with Endocanna Health to license and distribute its Endo.dnaTM test kits through its network of clinics. This is a significant example of the company making strides towards catering to its patient database and better understanding what their consumers need.

McAuley believes this testing can help doctors make better choices about the right treatment plan for their patients the more doctors know about their patients health prior to a consultation, the better. He notes, Our Sollievo line of CBD products has 25 unique CBD-based SKUs with different products targeting different ailments.

Empower will market the Endo.dnaTM kits not only through its clinics, but also through direct marketing to its 165,000-patient database. With six corporate clinics under the Sun Valley Health moniker and more on the way with franchising, the company is confident it can get the word out about how DNA testing can help doctors and patients make more informed cannabis and CBD-based recommendations.

Armed with a patients personalized health information, including genetic testing data, doctors can potentially help patients determine the type of cannabis or CBD, the specific dose and the type of delivery system that would be best suited to their ailments. For example, taking the Endo.dnaTM test results in a personalized report, called Endo-Decoded, that analyzes specific DNA markers to help guide doctor-patient decisions.

Virtual care: The consumer-centric revolution

As with most industries, healthcare is becoming more consumer-centric, and that goes beyond the digitization of health records to include options for how to see your clinician, including telemedicine. Increasingly, consumers are expecting solutions that are coordinated, convenient, customized and accessible.

This trend is being driven by several factors, including the increasing prevalence of chronic diseases, the growth of high-deductible insurance plans that push costs onto patients, the explosion of digital tools, emerging channels of competition within the healthcare market, and the coronavirus pandemic, which has shaken numerous industries.

McAuley explains, A telemedicine platform is available at all our Sun Valley clinics and, given the trends, we expect to see increased traffic through telemedicine. He sees this option as a way to amplify the reach and impact of Empowers network of clinics in Oregon and Arizona. This is also an important way to reach patients who are self-isolating at home or are in quarantine.

Although Arizona and Oregon have declared a State of Emergency over the coronavirus outbreak, as a medical service provider, Empowers corporate medical clinics are considered an essential service and are not subject to certain mandated closures. The company, has, however made changes to its clinic operations and patient management based on the most recent recommendations from the Centers for Disease Control and Prevention, and their guidance for healthcare facilities.

Empower expects its reach for the Sun Valley clinics to increase especially now that Sun Valley Health reached its first franchise agreement with a franchisee in Tulsa, Oklahoma. Franchising is the primary way Empower plans to expand its footprint in the U.S.

McAuley adds, Franchising Sun Valley Health is our preferred path. We would be willing to look at an acquisition of another clinic group, similar to what we did with Sun Valley, but were not interested in opening up single locations ourselves.

The company sees franchising as a force multiplier for the companys business model, one that will allow it to improve its healthcare approach and make its products and services available to more customers.

Advent of plant-based approached to health

With a hemp-based CBD extraction facility near Portland, Oregon, and that 165,000-patient database, Empower Clinics plans to stay in the vanguard of the CBD market.

McAuley comments, I know Professor MJ Malloy, who is heading up UBCs Cannabis Research division, is trying to understand the impact of cannabis on PTSD sufferers. In Arizona, Sun Valley is the largest certifier of veterans in the state we have a lot of data that could be very useful for its research.

At the end of 2019, a study carried out by the B.C. Centre on Substance Use (BCCSU) and the University of British Columbia (UBC) found that People who have PTSD but do not medicate with cannabis are far more likely to suffer from severe depression and have suicidal thoughts than those who reported cannabis use over the past year. This study surveyed more than 24,000 Canadians and was the first to document the relationships between PTSD, cannabis use, and severe mental health outcomes in a sample representative of the population.

More research is actively underway to explore the potential for cannabis to be used as a treatment for multiple sclerosis, substance use, as well as PTSD in veterans and first responders. Further results are expected to shine more light into the effectiveness of the cannabis plant, so it will be interesting to learn more as the data comes out.

And its not just cannabis and hemp-based CBD theres also growing trend of using psychedelics like psilocybin to help combat opioid use. The movement towards plant-based medical approaches is all part of a broader shift to stem away from opioids and prescription medicine, which have been blamed for causing overdoses in millions of people worldwide.

Riding healthcare trends to rapid growth

BDS Analytics and Arcview Market Research project that CBD sales in the U.S. alone will exceed USD$20 billion by 2024. Empower Clinic plans to ride that growth wave using its franchising model and strategic partnerships. That plan includes multiple revenue streams consisting of franchise fees, royalties, clinic revenues, CBD product sales and wholesale revenues from its extraction facility.

The partnership with Endocanna to distribute Endo.dnaTM kits, combined with its telemedicine offering, puts Empower at the forefront of CBD-based healthcare solutions, and makes them a significant thought leader in the space. Moreover, its vertically integrated model allows the company to both control its supply chain and realize increased margin.

Trading under the symbol CBDT.CSE, Empower projects its revenue will grow by more than 275 per cent by the time its exits 2021. With a highly experienced management team and board of directors, multiple revenue streams that are scalable, CBD product sales, technology IP development, and more, Empower Clinics appears to be well-positioned to capitalize on converging trends in plant-based health solutions and the digitization and personalization of healthcare.

The company understands that the current market conditions are affecting many industries, but healthcare shouldnt be compromised. People should be able to reach a doctor, even if it is remotely. To learn more about how the company stands out from the crowd, and how their telemedicine option works, visit their website here.

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Digital health and CBD are propelling Empower Clinics forward - BNNBloomberg.ca

An expert raises her concerns about direct-to-consumer testing and shares ways people can protect themselves.

In an interview with CURE, Lisa Schlager, vice president of public policy for Facing Our Risk of Cancer Empowered (FORCE) and a BRCA1 mutation carrier, discussed OTC genetic tests versus those provided by health care professionals and what consumers should keep in mind as they make health decisions.

CURE: What are the major differences between OTC genetic tests and those ordered by a physician or genetic counselor?

Schlager: Its like night and day. As an example, 23andMe has a component where you can opt to test for the BRCA mutations, although it looks for only three of the potentially thousands of BRCA mutations. The BRCA1 and BRCA2 gene mutations are associated with increased risk of breast, ovarian, prostate and pancreatic cancer, and some people are interested to know if they may have one of these mutations.

But when youre testing for only three of the potentially 5,000 mutations, and those three mutations are most commonly found in the Ashkenazi Jewish population, youre going to miss a lot of information. The fact that the Ashkenazi Jewish population is about 2% of the population in the United States means that 98% of the population in this country is unlikely to have those specific mutations.

If you were to go to a genetic counselor or a health care specialist with expertise in genetics, they would talk to you about your family history, determine which testing is most appropriate and probably give you a test that is much more expansive.

We must understand also that BRCA mutations are not the only mutations that cause an increased risk of cancer. We now have dozens of mutations with names like PALB2, CHEK2, ATM and Lynch syndrome. These are all mutations that cause increased cancer risk, and if you test for only the three BRCA mutations, youre really not getting good information about your potential risk.

How can consumers determine which OTC tests are reputable?

There have been a lot of reports in the media of people selling tests to unwitting consumers who dont realize who they are dealing with, who dont realize that theyre being duped out of their insurance or Medicare information. I think the important thing is that if you go to a qualified health care professional, they are more likely to steer you to a reputable genetic test. If youre going to do a test over the counter, look at it for what it is. Its kind of a fun thing, and it may provide you with some interesting information, but the best place to learn about health risks and health conditions is through a qualified health care professional or genetics counselor. Ultimately, if you do test positive for one of these health risks ... you need to confirm it with a health care provider anyway. The other thing to be aware of is that if something seems suspicious, go with your gut.

Should consumers be more aware of certain characteristics of these fraudulent tests?

Absolutely. (Be wary of) those that are making promises about coverage and that everyone is able to get it covered now, 100% free or no cost to you, or if they are aggressively marketing. We have seen people marketing these tests at health fairs and senior centers. Thats not a reputable way to do this. Thats not how health care is supposed to be done.

Some of these tests, such as 23andMe, have been approved by the Food and Drug Administration (FDA). What does this mean?

FDA approval means that the FDA has vetted it and determined that the test is in fact accurate for what it claims to do. The reality is that the vast majority of genetic tests are not FDA approved, they are CLIA (Clinical Laboratory Improvement Amendments) approved, which is a designation under the Centers for Medicare & Medicaid Services.

So, it comes down to knowing who is providing the test to you and making sure that the company, the test provider, the laboratory, is a reputable lab.

What is the biggest takeaway for consumers who are concerned about their risk?

Talk to a doctor that you have a relationship with and share your concerns. Most doctors will either have a mechanism for assessing risk in office or will refer you.

Ultimately, there is coverage for genetic testing for people who have a family history or personal cancer history. People dont need to turn to these less reliable tests to get the testing.

Read the original post:
Genetic Testing: Are Over-the-Counter Options Reliable? - Curetoday.com

One of the hallmarks of the single-origin specialty coffee movement has been an appreciation for specific varieties within the arabica species of coffee.

Like the Pinot Noir or Cabernet Sauvignon varieties to wine, coffee varieties such as Bourbon, Pacamara or Gesha are not merely used as identifiers; theyre also employed as marketing terms. But what if that 91-point Gesha in your cup is actually a 91-point something else? Heaven forbid.

Research released last month that used genetic fingerprinting to determine the veracity of genetic labeling of thousands of coffee plant suggests the mis-identification of varieties on farms and even in nurseries may be widespread.

DNA fingerprinting provides different actors in the coffee sector with a powerful new tool farmers can verify the identity of their cultivated varieties, coffee roasters can be assured that marketing claims related to varieties are correct, and most of all, those looking to establish a more professional and reliable coffee seed sector have a reliable new monitoring tool to establish and check genetic purity of seed stock and nursery plants, the authors of the open-access study in the in theJournal of AOAC International.

Behind the study is the Portland, Oregon-based nonprofit World Coffee Research, which it should be noted has a vested interest in promoting this type of DNA fingerprinting. The group launched a DNA fingerprinting service for the authentication of arabica coffee in 2017, and charges $130 per sample.

For the newly published study, researchers applied the DNA fingerprint testing to more than 2,500 coffee samples in its database, which came from numerous sources, including WCRs core collection and anonymized samples sent by individuals. Samples originated from coffee-growing countries all over the world.

In one of the starkest examples of genetic nonconformity, only 39% of the 88 samples identified as the famous Gesha variety (often written as Geisha elsewhere) were found to truly be Gesha.

Researchers noted incidental cross-pollination on the farm as a potential likely route to genetic ambiguity on farms and in nurseries.

Experience with the WCR genetic database points to the conclusion that a recently selected variety in a region with a relatively organized research and nurseries network exhibit higher genetic conformity, the authors wrote. The best example of this currently is the Marsellesa variety, with 91% of genetic conformity. However, when varieties are older and/or the research and nurseries network is poorly organized, the percentage of genetic conformity can drastically decrease.

See the full open-access study here.

Related Reading

Nick Brown Nick Brown is the editor of Daily Coffee News by Roast Magazine. Feedback and story ideas are welcome at publisher (at) dailycoffeenews.com, or see the "About Us" page for contact information.

Tags: AOAC International, genetics, Gesha, research, science, varieties, World Coffee Research

Original post:
Genetic Testing Reveals the True Nature of Coffee Varieties - Daily Coffee News

DUBLIN--(BUSINESS WIRE)--The "Global Genetic Testing Market Outlook 2022" report has been added to ResearchAndMarkets.com's offering.

The advent of genetic tests has revolutionized the molecular diagnostics and cytogenetic industry. It is one of the most rapidly growing segments in the molecular diagnostics industry, which helps in delivering customized health services or personalized medicine.

The share of genetic testing is incessantly increasing in the market. Growing awareness about genetic testing, technological advances in genetic sequencing, and rising incidences of genetic diseases especially cancer are some of the major factors propelling the genetic testing market.

Global Genetic Testing Market Outlook 2022 provides a detailed analysis of the genetic testing market. The report also provides insight regarding the current and future perspectives of the market. This report covers the major trends and drivers, and their impact on the market. The report also discusses some of the restraints that can hinder the growth of the market, as well as rising opportunities which can provide new dimensions to the industry.

The segmentation of genetic testing markets has been done in the report on the basis of applications, diseases, and geographical regions.

1) Based on the application, the genetic testing market is divided into Diagnostic Testing, Newborn Screening, Prenatal Testing, Carrier Screening, and Others. Diagnostic testing and Newborn screening are the major application areas of genetic testing industry. The large shares of these applications can be attributed to the presence of huge players in the segment, and to the rising number of genetic tests performed for this purpose. The Carrier Testing market is expected to witness the highest growth during 2017-2022. This growth is likely to be driven by the huge population opting for carrier screening of cystic fibrosis, exhibiting an unprecedented rise in the US. The report provides a current and forecasted market for each of the application areas of Genetic Testing.

2) The major disease profiles/conditions for which Genetic Testing is used include Alzheimer's Disease, Cystic Fibrosis, Cancer, Down Syndrome, and Others. Cancer accounts for the largest share amongst the diseases for which genetic testing is done. This large share can be attributed to the rising prevalence of cancer, which is expected to increase as the global population ages. Approximately 75-80% of all cancers are diagnosed in people aged 55 or older, and this pattern is expected to increase by 2020. The report provides a current and forecasted market for each of the genetic conditions of Genetic Testing.

3) Moreover, the report also contains markets for the major regions including North America, Europe, Asia Pacific, and Rest of the World. North America contributes the largest share in the global genetic testing market, followed by Europe. The presence of major players increased awareness and higher disposable income, are some of the prominent factors that have led to North America being the market leader. The Asia-Pacific market is expected to witness the highest growth during 2017-2022. The major reasons for the high growth are the increasing per capita income and gradual development of the healthcare sector in countries, such as India and China. North America and Europe are expected to grow at a modest rate due to the launch of new and innovative products in these markets.

Competitive Landscape

The company profiles segment in this report is entirely devoted to profiling leading companies of the genetic testing industry including some major players like Abbott Laboratories, Roche Diagnostics, Myriad Genetics, Inc., Thermo Fisher Scientific, Inc., Hologic, Inc., Cepheid, Agilent Technologies and QIAGEN. This segment provides you access to the newly launched products, recent developments, and strengths and weaknesses of these companies to deliver a clear understanding/view of the competitive landscape.

Overall, the report will prove to be a complete source of knowledge and analysis for clients and potential investors.

Key Topics Covered

1. Analyst View

2. Research Methodology

3. Genetic Testing Overview

3.1 Applications and Advantages

3.2 Methods

3.3 Genetic Testing Laboratories - Unmet Need Analysis

4. Industry Overview

4.1 Drivers

4.1.1 Rising Incidence of Chronic Diseases

4.1.2 Growth in Ageing Population

4.1.3 Increasing Government Initiatives

4.1.4 Rising Investments in Genetic Testing Market

4.1.5 Incessant Launch of New Genetic Tests

4.2 Challenges

4.2.1 Low Awareness for Genetic Testing in Developing Countries

4.2.2 High Cost of Genetic Tests

4.2.3 Varying Reimbursement Policies

4.2.4 Ethical and Policy Issues

4.3 Opportunities

4.3.1 Next-Generation Sequencing (NGS)

4.3.2 Non-Invasive Prenatal Testing (NIPT)

4.3.3 Whole Genome Sequencing (WGS) for Cancer

4.3.4 Personalized Medicine

4.4 Trends

4.4.1 Genetic Testing in Oncology: Gaining Momentum

4.4.2 Strong Demand for Pharmacogenomics

4.4.3 At-Home DNA Tests or Direct-To-Consumer (DTC) Genetic Tests

5. Global Genetic Testing Market Outlook

6. Global Genetic Testing Market by Application

6.1 Carrier Testing

6.2 Diagnostic Testing

6.3 New Born Screening

6.4 Predictive & Pre-Symptomatic Testing

6.5 Prenatal Testing

6.6 Others

7. Global Genetic Testing Market by Disease

7.1 Alzheimer's Disease

7.2 Cystic Fibrosis

7.3 Cancer

7.4 Down Syndrome

7.5 Others

8. Global Genetic Testing Market by Geography

8.1 North America

8.2 Europe

8.3 Asia-Pacific

8.4 Rest of the World (RoW)

9. Genetic Testing Regulations

10. Mergers & Acquisitions

11. Company Profiles (Overview, Product Offering, Financials, Developments, Strength & Weakness)

11.1 Abbott Laboratories

11.2 Roche Diagnostics

11.3 Myriad Genetics, Inc.

11.4 Thermo Fisher Scientific, Inc.

11.5 Agilent Technologies, Inc.

11.6 Hologic, Inc.

11.7 Illumina, Inc.

11.8 QIAGEN N.V.

11.9 Cepheid

11.10 Quest Diagnostics

For more information about this report visit https://www.researchandmarkets.com/r/7hcy1w

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Global Genetic Testing Market Outlook to 2022 by Application, Disease & Geography - ResearchAndMarkets.com - Business Wire

Preimplantation Genetic Testing Market 2020 Analysis by Segments, Share, Application, Development, Growing Demand, Regions, Top Key Players & Forecast 2025

The global preimplantation genetic testing market report covers deep insights of various vital aspects of the market. The Global preimplantation genetic testing market research report delivers deep insights about the different market segments based on the end-use, types and geography.

Moreover, in past few years, the market of preimplantation genetic testing has recorded a significant development and is anticipated to further rise.

Top Leading Key Players are:

Thermo Fisher Scientific, Inc., Agilent Technologies, Inc., PerkinElmer, Inc., CooperSurgical, Inc., Beijing Genomics Institute (BGI), Abbott Laboratories, Natera, Inc., Genea Limited, Rubicon Genomics, Inc. and Oxford Gene Technology

Request sample copy of this report at: http://www.adroitmarketresearch.com/contactample/1483

Market research report for every industry is based on various important factors, for example demand & supply, market trends, revenue growth patterns and market shares. Report on the Global preimplantation genetic testing market is made after a comprehensive research conducted by a systematized methodology.

These techniques are helpful for analyzing the market on the terms of research guidelines. Basically, research reports covers all the information about the consumers, vendors, manufactures, research papers, products and many more.

They provide a range of marketing as well as business research solutions basically designed for the readers looking forward to invest in the market. Moreover, their research report are collection of a particular industry research that includes information on products, market size, countries, trends, business research details & much more.

Furthermore, research report covers all the quantitative as well as qualitative aspects about the preimplantation genetic testing markets across the globe. The report is also inclusive of different market segmentation, business models and market forecasts.

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Read complete report at: http://www.adroitmarketresearch.com/industring-market

Global Preimplantation Genetic Testing Market is segmented based by type, application and region.

Based on Type, the market has been segmented into:

by Test Type (Aneuploidy, Structural Chromosomal Abnormalities, Single Gene Disorders, X-linked Disorders, HLA Typing, Gender Identification) and Technology (Next Generation Sequencing, Polymerase Chain Reaction, Fluorescent In-Situ Hybridization, Comparative Genomic Hybridization, Single Nucleotide Polymorphism)

One of the most crucial feature of any report is its geographical segmentation of the market that consists of all the key regions. This section majorly focuses over several developments taking place in the region including substantial development and how are these developments affecting the market.

Regional analysis provides a thorough knowledge about the opportunities in business, market status& forecast, possibility of generating revenue, regional market by different end users as well as types and future forecast of upcoming years.

The key factor important for making any new business effective is advancement or making impactful modifications in the business. Report on Global preimplantation genetic testing market, is an extensive papers that covers all the aspects of the market analysis and enables a comprehensive summary to its readers.

In a nutshell, the preimplantation genetic testing market research reports is a one-stop solution for all requirements by the in-house experts.

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New study: Preimplantation Genetic Testing Market interpreted by a new report - WhaTech Technology and Markets News

Mycobacteria, belonging to the genus Mycobacterium of the family Actinobacteriaceae, are immobile, rod-shaped, Gram positive bacteria. These bacteria can be divided into three groups for the purpose of diagnosis and treatment: Mycobacterium tuberculosis complex (MTBC), the causative pathogens of tuberculosis (TB); nontuberculous mycobacteria (NTM), with varying pathogenic potential; and Mycobacterium leprae, the causative pathogen of leprosy.Mycobacteria are widespread organisms, typically living in soil, water, animal tissue, and food sources, and can colonize their hosts without inducing any pathogenic signs or can cause latent infections that can lead to severe diseases. Although the genus Mycobacterium was first introduced in 1896, infections by MTBC organisms and NTM continue to challenge physicians and microbiologist across the globe. The unique cell wall characteristics of mycobacteria prevent them from being stained by the standard Gram stain procedure. Due to this acid-fastness, specific diagnostic tests are required such as auramine-rhodamine or Ziehl-Neelsen staining.

Differentiation between MTBC and NTM can be achieved by immunochromatography, but exact species identification requires more sophisticated techniques such as molecular diagnostics. The infections resulting from MTBC are difficult to treat due to intrinsic resistance to antibiotics like penicillin G, sulfonamides, tetracycline, erythromycin, and chloramphenicol. [1] Mycobacteria can survive exposure to acids, alkalis, detergents or oxidative bursts, but fortunately most NTM are susceptible to the antibiotics clarithromycin and rifamycin, although antibiotic resistant strains have also emerged, presenting a new threat to global public health.

The global TB epidemic

MTBC species include M. tuberculosis, M. bovis, M. affricanum, M. canetti, M. microti, and M. pinnipedii, with the most common TB-causing pathogen in humans considered to be M. tuberculosis. These pathogens are transmitted via droplet infection through the air by coughing, sneezing, and speaking. In high incidence countries, the risk of infection is greatly increased in densely populated areas, with infants and immunocompromised patients at heightened risk.

TB is one of the top 10 causes of death throughout the world and is the leading cause of death from a single infectious agent (above HIV/AIDS and malaria). In 2017, it was estimated that 10 million people per year developed the disease,[2] and approximately 1.7 billion people (23% of the worlds population) are estimated to have a latent TB infection and are therefore at risk of developing active TB disease during their lifetime.[3]

Early diagnosis and rapid, appropriate medication are needed to improve TB treatment success, which remains low at around 55% globally. Treatment efforts are also hampered by the persistence of drug-resistant TB strains. Recent estimates demonstrate that, in 2017, 558,000 people developed rifampicin-resistant TB (RR-TB) TB with resistance to the most effective first-line drug and that 82% of these cases were resistant to the second first-line drug, isoniazid, and are therefore described as multidrug-resistant TB (MDR-TB). [3] [4]

Closing the gap between detection and treatment requires more specific drug susceptibility testing among those diagnosed with TB. The therapy for MDR-TB is more time consuming and is characterized by more frequent and severe side effects. This has led to a lower compliance rate among treated patients, resulting in a further increase in drug resistances. If the infecting organism is resistant to the two first-line antibiotics (rifampicin and isoniazid) and at least one drug from each of the classes fluoroquinolones and second-line injectable agents (amikacin, capreomycin or kanamycin), it is classed as extensively drug-resistant (XDR)-TB. [5] Identifying the drug resistance pattern is therefore crucial to establishing a successful treatment plan to cure the patient and stop the transmission of resistant strains.

Challenges of mycobacteria detection

The distinction between TB and NTM is essential for diagnosis and treatment, and the course of action depends on the respective mycobacteria species. Genotypic (molecular) methods for species differentiation and resistance testing are valuable tools in TB and NTM diagnostics and offer considerable advantages compared with time-consuming conventional methods, such as biochemical testing and phenotypic resistance testing.

The process for identifying TB using traditional culture methods often takes 2-4 weeks for a positive result, and 6-8 weeks for a negative result (which then requires further testing) depending on whether solid or liquid media have been used. This is considerably slower compared with genetic testing, where identification for TB and NTM can be done in under 3 hours. Genetic testing offers a clear advantage for patients, as resistance patterns are available earlier for adequate treatment.

Additionally, there is no requirement for a laboratory to have biosafety level 3 laboratory (BSL3) credentials for molecular methods, because these tests can be performed from direct decontaminated samples. Via the direct sampling method, any laboratory can run genetic testing on samples to determine the presence or absence of M. tuberculosis and conduct further testing to identify NTM.

In May 2016, the World Health Organization (WHO) issued new recommendations on the use of a rapid diagnostic test the line probe assay (LPA) GenoType MTBDRsl to detect resistance to second-line anti-TB drugs (SL-LPA). [6] Compared with traditional culture-based techniques, LPAs are a more reliable method for ruling out resistance to the second-line antibiotics fluoroquinolones and the injectable drugs capreomycin, kanamycin and amikacin, enabling clinicians to set patients on the proper regime at the earliest time.

Detection of any second-line resistance by the SL-LPA means that MDR-TB patients should not be enrolled on the shorter regimen, as this could jeopardize their treatment outcome and fuel the development of XDR-TB. Patients detected with XDR-TB should also not be enrolled on the shorter regimen and require carefully designed individual regimens to optimize successful treatment.

Clinical impact of molecular testing

Professor Robert Warren, Unit Director and Chief Specialist Scientist, South African Medical Research Council (SAMRC), focuses his research on molecular epidemiology and has continually challenged assumptions related to TB.His findings have demonstrated that transmission of TB occurs largely outside of the household and that the drug resistance epidemic is driven by transmission, especially in previously treated patients, implying reinfection.

South Africa is considered the largest consumer of molecular diagnostic testing for TB, and in Cape Town alone, more than 15,000 LPAs are estimated to be carried out per year. Prof Warrens experience with this type of testing is extensive.

The picture in South Africa is very different in terms of the incidence of TB, explains Prof Warren, continuing: The country already had a high incidence rate but with the onset of HIV in the 1980s, this rapidly accelerated until our rates were among the highest in the world. The focus of our health system in the early 2000s was to halt the increase of drug-susceptible TB, but the downside of this is that drug-resistant TB got overlooked. Our figures now show that we appear to be on the downward trend for susceptible TB incidence, but now the focus needs to shift onto drug-resistant TB.

Molecular tools such as the SL-LPA have changed the landscape for testing in South Africa. Convincing physicians to move away from the traditional phenotypic testing to genetic testing was an initial barrier to the introduction of this method but once the benefits became clear, the adoption was swift.

Prof Warren describes his role in developing TB identification methods: At the research center, we have been responsible for evaluating the diagnostic tools that are available on the market before passing our findings to an independent panel, who then make recommendations to the Department of Health. From the work that we have carried out, the line-probe assay is now one of our most used testing methods for second-line TB identification.

The future for molecular testing in the area of TB, in my opinion, will need to focus on the low to middle income countries that dont have the necessary infrastructure in place for complex or specialized testing, explains Prof Warren. There are two different schools of thought here to develop a test that will deliver results against a defined set of drugs, or to develop a test that will provide results against a comprehensive set of drugs. Each solution has its place but either way, the test needs to be as simple as possible and the results easy for a lab technician to understand without specialist knowledge.

Future outlook for mycobacteria

The ability to optimize patient treatment by providing a rapid, reliable mycobacteria identification is improving health outcomes of TB and NTM infections worldwide. The future of TB and NTM testing is changing. As higher rates of TB are being detected in undeveloped countries where investment in laboratories and detection infrastructure is lower, the methods of testing need to be adjusted accordingly. There will be fewer trained technicians in these locations and molecular testing will need to become more intuitive to meet this throughput requirement.

The WHO recommendation of the SL-LPA molecular test to detect resistance to second-line anti-TB drugs indicates a step-change in the treatment of this disease. For these diagnostic tests to be applicable into the future, a more comprehensive outlook is required for assay development. In its End TB Strategy, the WHO has a shared vision of a world free of TB with zero deaths, disease and suffering by 2035.[3] This requires a 95% reduction in the absolute number of TB deaths and a 90% reduction in incidence rate compared with the 2015 baseline. Early diagnosis of TB, including universal drug-susceptibility testing and systematic screening of high-risk groups, will be a key component in achieving this target.

References

(1) Jarlier V and Nikaido H (1994) Mycobacterial cell wall: structure and role in natural resistance to antibiotics. FEMS Microbiol. Lett. 123:1118.

(2) Porvaznik I, Solovi I, Mokr J (2017) Non-Tuberculous Mycobacteria: Classification, Diagnostics, and Therapy. Adv Exp Med Biol, 944: 19-25.

(3) Tuberculosis (TB) Data & Statistics, Centers for Disease Prevention and Control (CDC), 2018, https://www.cdc.gov/tb/statistics/default.htm.

(4) TB Elimination: Extensively Drug-Resistant Tuberculosis (XRD TB), Fact Sheet, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), 2013, https://www.cdc.gov/tb/publications/factsheets/drtb/xdrtb.pdf.

(5) World Health Organization Global Tuberculosis Report 2018: https://www.who.int/tb/publications/global_report/en/

(6) The use of molecular line probe assays for the detection of resistance to isoniazid and rifampicin, Policy Update, World Health Organization, 2016, https://apps.who.int/iris/bitstream/handle/10665/250586/9789241511261-eng.pdf?sequence=1.

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Molecular Testing Closing the Gap Between TB Detection and Treatment - Technology Networks

When Oklahomas first confirmed case of COVID-19 was reported on March 6, there were already hundreds of cases nationwide and hot spots were beginning to emerge in other states. Not considered a priority by the federal government, Oklahoma was issued a minimal amount of the reagents necessary to run a coronavirus test.

Doctors were told to be selective in ordering tests for patients, reserving the limited supply for those with the most severe symptoms.

Tests were denied for some Oklahomans with mild symptoms who were left unsure if they were at risk of spreading the virus to others.

Oklahoma saw COVID-19 cases much later than other states and we were not getting as many government provided reagents as other states, said Kayse Shrum, Oklahomas secretary of science and innovation.

Hoping to find a way to increase the states testing capacity, Shrum called Elizabeth Pollard, an Edmond resident who had spent 25 years working in genetic testing and was in the process of building an infection control company in Silicon Valley.

Knowing that Oklahoma State Universitys diagnostic laboratory already had Thermo Fisher equipment, Pollard, who became the states deputy secretary of science and innovation earlier this year, called her contacts at the company and put Oklahoma in a position to order 10,000 COVID-19 test kits as soon they received FDA approval.

It was a match made in heaven, Pollard said about the OSU lab and Thermo Fisher.

Both Shrum and Pollard are key members of the governors coronavirus response team and have been central figures in crafting the states testing strategy, which has relied more on private companies than the federal government.

State and private labs have tested more than 13,000 Oklahomans a rate of 330 per 100,000 residents and the number of confirmed positive cases was at 1,327 on Monday.

Oklahomas rate is in the bottom third nationally, but if the state is going to significantly increase its testing in the coming days and avoid a future designation as a COVID-19 hotspot it will likely be because of Shrum and Pollard.

Shrum began appearing publicly with Gov. Kevin Stitt in mid March shortly after state epidemiologist Laurence Burnsed, who had been a participant in most media conferences with the governor, was abruptly replaced. Criticism toward state officials was intensifying as residents and health care officials complained of a lack of testing and mixed messaging.

Shrum has been described as a calm presence, a person who speaks with authority but not in complex terms, according to multiple people with knowledge of behind the scenes conversations.

Stitt embraced Shrums ability to communicate beyond scientific jargon and appreciated her perspective on other health consequences of the pandemic, including depression and suicide, according to multiple sources.

Stitt created a coronavirus response task force on March 15 that included Shrum, and because she was a liaison to the state medical community, the governor now had direct information from the frontlines of the pandemic.

She is a constant voice of science, wisdom, and experience, and an exceptional team player, said John Budd, Stitts chief operating officer and leader of the task force.

Budd said Shrum is working with Secretary of Health Jerome Loughridge to oversee the states plan to increase personal protective equipment for health care workers, ventilators, hospitals and ICU beds.

Shrum credits Pollard for helping Oklahoma compete with other states for testing kits from private labs at a time when a delayed response by federal leaders resulted in a shortage of tests available.

While testing is important to identify specific cases, inform individuals of the need to self isolate and give health care workers confirmation that they are treating a person with the virus, it is also valuable data in tracking the spread of COVID-19 and identifying local trends.

We just dont have enough testing to really see any specific trends yet, said David Holt, mayor of Oklahoma City, where there are nearly 500 confirmed cases in the citys metro.

But I think we have seen it get a lot better lately in the ability to do more tests locally, which will be key to better understand this.

While the state had a shortage of testing kits for most of March, it now has the ability to complete 2,800 tests each day, according to Shrum.

The number of tests performed by the state is likely to rise with more than 70 mobile testing sites throughout the state, a significant increase from the 16 in operation just a few days ago.

Last week, Stitt urged doctors to test anyone who has symptoms, such as a fever or shortage of breath. He also urged tests for those who have come in contact with another person who has tested positive for COVID-19.

The best way to slow the curve and stop the spread is more testing and tracing as well as continuing to practice social distancing, Stitt said last week.

Shrum said increasing the states testing capacity will be critical for modeling and creating a detailed response plan.

More testing means more clarity on what is happening in the community and it helps us project and look into the future, Shrum said.

While most of the nearly 13,000 tests have been run through private labs, which is where most doctors and clinics send their tests, state officials say it is important for the state labs to test more Oklahomans in order to better track trends.

The state labs are also free and can process results within a day.

Most private labs report a turnaround time of 24 to 48 hours, but that accounts for only the time tests are at a lab. Many private labs are out of state in larger markets, such as Dallas and Seattle, which can take multiple days of travel.

Pollard said Oklahoma continues to compete with other states for testing kits and resources but the state recently secured 15 Abbott testing machines, which can analyze a nasal swab in just a few minutes.

However, Abbott is selecting which states to send the necessary test kits with guidance from the Trump administration. Oklahoma has received only 100 of those kits.

We saw our first case later and there are states that are peaking faster than us and those are going to be the priority, Shrum said.

In addition to the state Department of Health and OSU labs, the University of Oklahoma lab could be receiving tests within the next week or two, according to officials.

While the state only has 100 kits for its quick response Abbott machines, the lab at OU is researching ways to develop its own kits that could be used.

Unlike genetic tests like the ones used in Thermo Fisher machines, most rapid tests detect protein antibodies, which can take about 10 days for infected people to develop.

While the antibody machines are not as accurate as genetic tests, they could be used to test individuals to determine if they have ever had the coronavirus, which would be valuable if its determined an infected person develops immunity.

State testing supplies were limited less than a month ago but Shrum said supply is no longer an issue, at least not right now.

Early on we had really pushed hard to say hospitalized health care workers and the vulnerable population were the only people who should be tested and I think our frontline professionals were listening, Shrum said.

But we have been able to scale very quickly and we are looking to do significantly more tests.

The Frontieris a nonprofit corporation operated by The Frontier Media Group Inc.

We are making critical coverage of the coronavirus available for free. Please consider subscribing so we can continue to bring you the latest news and information on this developing story.

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The Frontier: Oklahoma's competition for coronavirus tests and the women leading the fight - Tahlequah Daily Press

We just had the pleasure of sitting down virtually with our amazing JSA Board Member, Elsa Pine, VP of Sales and Business Development at EdgeConneX to learn more about her recent journey with breast cancer, particularly during these trying times of the Covid-19 pandemic. May her story be a source of inspiration for our community, and provide hope during these difficult days.

Q: Lets begin with the great news first you just had very successful surgery. Let us know how you are recovering.

I am recovering well, and gaining my mobility quickly. My nerves are finally returning to my left side. And gratefully, my right side is back to normal!

I rode my bike with my son yesterday for quite a few miles!

My spiritual transformation had already begun before this surgery, so my mindset is in GO mode. For example, my iPhone music playlist is entitled LETS DO THIS!!.

Coming up, I have chemo and radiation, and we just got word that we are still full steam forward. My next surgery will be the laparoscopic removal of my ovaries, which will shut down the production of estrogen, to keep this cancer at bay.

I have been blessed to already have three amazing kids, so Im very lucky to have had these body parts and hormones serve their purpose. I will replace them with healing, for me and for others, like my very supportive family and friends.

Q: You also had genetic testing done at the time of your biopsy, why?

My amazing radiologist Dr. Susan Drossman was very surprised by a recent 3-D mammogram that didnt catch this fast-growing Lobular Carcinoma. During my biopsy, two out of seven needles bent, giving me a false response. Thank goodness that Dr. Drossman and her entire team make sure everyone also receives genetic testing with their biopsies.

Additionally, as my mom had battled with breast cancer twice twenty years ago, and therefore we had family history, Dr. Drossman also sent the tumor for additional testing to my Mount Sinais Dubin Center rockstar team, Dr. Elisa Port and Dr. Hannah Irie.

I received my results within ten days, and Ill never forget that call.

They tested over 84 genetic variants. I tested positive for BRCA2, a pathogen associated with autosomal dominant hereditary breast and ovarian cancer syndrome. As it turns out, my youngest sister (there are 3 girls in my family), who is 37-years-old, also has this BRCA2 mutation.

Additionally, my sisters Ancestry DNA Test also revealed our 14% Ashkenazi heritage. Certain genetic disorders are more common in Ashkenazi Jews. So although we never checked my dads side of the family previously, we realized we had breast cancer risk on both my mom and my dads side.

Q: What life changes did you make to prepare for surgery and for your healing? How did these measures make a positive impact for you?

I immediately changed to a plant-based diet, with lots of beet juice and carrot juice.

I also increased meditation to a few times per day, including a lot of walking meditation which has allowed me to connect even more with nature (birds, wind, trees, flowers). Its amazing when you are alone walking and not listening to music, how in tune with nature you can become (and it also helps to walk with my two dogs, Peyton and Brady).

In general, I am strengthening and nourishing my body as I prepare for the next steps on my path to healing.

Q: Knowing the world has changed for us all recently, how are you spending your days?

I walked into Mount Sinai West on 3/12 at 12:30 PM, with a planned surgery time of around 2 PM. When I finally came out of recovery at 10:30 PM, the world had changed.

I was in a private room, but I saw the fear in the staff and my husbands eyes. Something drastically shifted with the energy and I felt it strongly.

When I left the hospital on Saturday morning, the city was so quiet. It was eerie, and yet so peaceful at the same time.

Ive been in quarantine since 12/30/19, so adapting to these pandemic times was not new for me. I continue to work from home, burn palo santo a few times a day to air the rooms of germs, and also to help keep me calm.

Additionally, and like so many homes across this globe right now, we are burning candles and disinfecting surfaces, like light switches, door knobs, faucets, etc- anything my kids touch often.

My family and I are also preparing for chemo, which begins on 4/15, so very soon. I do have fears, as most chemo patients do, and these fears are multiplied due to Covid-19, but I am digging deep!

Q: What or who has inspired you the most this year?

I have to say, my Reiki Life Coach, Valisha Lasker, owner of Remedy 11, has inspired me to dig deeper into my own soul, to find comfort in love and in peace. She is a miracle worker with crystals, and has been guiding me through with empowering messages. Its been a wonderful experience to tap into the energy that is within me. I feel my energy moving freely now, not stuck, and able to not just heal me, but heal others.

Q: What are you most grateful for?

Im very grateful for my family, my amazing medical team, friends, colleagues, and Mother Earth. It is in nature that Im at my best, and she has taught me to be patient, pause, and just be present. I hope through all of this, we all learn to be a bit more patient and kinder to each other and to Mother Earth. It is through love that transformations happen, and mine is just beginning.

Ms. Elsa, we love you and we are praying for you. We are all sending you our biggest virtual hugs! Thank you for sharing your story and continuing to be a source of inspiration and strength for us. Namaste.

Read more:
Elsa's Story - JSA Advisory Board Member Update on her Battle with Breast Cancer During These Difficult Times - JSA

SALT LAKE CITY, April 08, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN), a global leader in personalized medicine, announced today that due to the impact of the global COVID-19 pandemic, the company is withdrawing its fiscal year 2020 financial guidance.

Prior to mid-March we were experiencing volume trends consistent with our expectations across all products; however, recent social distancing guidelines have had a significant impact on test volume trends in late March and into the fiscal fourth-quarter, said R. Bryan Riggsbee, interim president and CEO and chief financial officer at Myriad Genetics. Our priority as an organization during the coronavirus pandemic has been to maintain business continuity and access to testing, while ensuring the safety of our employees and customers. As an organization we have taken steps to advance these dual aims, and I am very proud of how the Myriad team has responded to the crisis.

In responding to the pandemic, Myriad has made several changes to its business practices to promote the safety of both customers and employees including ceasing in-office sales calls and implementing virtual selling, granting all non-essential personnel the ability to work from home, enabling direct sample collection for patients and implementing policies to improve laboratory personnel safety.

While the uncertain timeframe of the Coronavirus pandemic makes it difficult to predict future business trends for the company, the company will provide an update on its business, including the impact of COVID-19, on its next quarterly earnings call.

About Myriad GeneticsMyriad Genetics, Inc. is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prequel, ForeSight, GeneSight and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to maintaining the Companys global leadership in precision medicine and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of the Companys existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to the Companys ability to successfully transition from its existing product portfolio to our new tests; risks related to changes in the governmental or private insurers reimbursement levels for the Companys tests or the Companys ability to obtain reimbursement for its new tests at comparable levels to its existing tests; risks related to increased competition and the development of new competing tests and services; the risk that the Company may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that the Company may not successfully develop new markets for its molecular diagnostic tests and pharmaceutical and clinical services, including the Companys ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying the Companys molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating the Companys laboratory testing facilities; risks related to public concern over the Companys genetic testing in general or the Companys tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to the Companys ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to the Companys ability to successfully integrate and derive benefits from any technologies or businesses that it licenses or acquires; risks related to the Companys projections about the potential market opportunity for the Companys products; the risk that the Company or its licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying the Companys tests; the risk of patent-infringement claims or challenges to the validity of the Companys patents; risks related to changes in intellectual property laws covering the Companys molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that the Company may be unable to comply with financial operating covenants under the Companys credit or lending agreements; the risk that the Company will be unable to pay, when due, amounts due under the Companys credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of the Companys most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in the Companys Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Story continues

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Myriad Withdrawing Financial Guidance for FY2020 Due to Business Impact from Coronavirus Pandemic - Yahoo Finance

Pre-implantation genetic diagnosis is the genetic profiling of embryos prior to implantation, and sometimes even of oocytes prior to fertilization. PGD is considered in a similar fashion to prenatal diagnosis

Get Sample Copy of This Report @ https://www.orianresearch.com/request-sample/1374539

The global preimplantation genetic testing market was estimated to be valued at USD XX million in 2019 and is projected to reach USD XX million by 2026, at a CAGR of XX% during 2020 to 2026. Rising number of fertility clinics worldwide market are the factors supporting the market growth globally. However, high procedural cost associated with preimplantation genetic testing is expected to hamper the growth of the global market.

The global preimplantation genetic testing market is segmented based on procedure type, technology, and region. Based on procedure type, it is divided into preimplantation genetic screening, preimplantation genetic diagnosis. Based on technology, it is categorized next-generation sequencing, polymerase chain reaction, fluorescence in situ hybridization, comparative genomic hybridization, single-nucleotide polymorphism. Region wise, it is analyzed across North America, Europe, Asia-Pacific, South America, and MEA.

On the basis of procedure type, the market is split into:* Preimplantation Genetic Screening* Preimplantation Genetic Diagnosis

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On the basis of technology, the market is split into:* Next-Generation Sequencing* Polymerase Chain Reaction* Fluorescence in Situ Hybridization* Comparative Genomic Hybridization* Single-Nucleotide Polymorphism

Moreover, the market is classified based on regions and countries as follows:* North America- U.S., Canada* Europe- U.K., France, Germany, Italy and Rest of Europe* Asia-Pacific- China, Japan, India and Rest of Asia Pacific* South America- Brazil, Mexico and Rest of South America* Middle East & Africa- South Africa, Saudi Arabia and Rest of Middle East & Africa

Key Market Players:The key players profiled in the market include:* Illumina, Inc.* Thermo Fisher Scientific Inc.* Agilent Technologies, Inc.* Perkinelmer, Inc.* Coopersurgical, Inc. (A Subsidiary of the Cooper Companies, Inc.)* ABBott Laboratories* Natera, Inc.* Rubicon Genomics (A Subsidiary of Takara Bio USA Holdings, Inc.)* Oxford Gene Technology* Yikon Genomics

These enterprises are focusing on growth strategies, such as new product launches, expansions, acquisitions, and agreements & partnerships to expand their operations across the globe.

Key Benefits of the Report:* Global, regional, country, procedure type, technology and market size and their forecast from 2015-2026* Identification and detailed analysis on key market dynamics, such as, drivers, restraints, opportunities, and challenges influencing growth of the market* Detailed analysis on industry outlook with market specific PESTLE, and supply chain to better understand the market and build expansion strategies* Identification of key market players and comprehensively analyze their market share and core competencies, detailed financial positions, key products, and unique selling points* Analysis on key players strategic initiatives and competitive developments, such as joint ventures, mergers, and new product launches in the market* Expert interviews and their insights on market shift, current and future outlook, and factors impacting vendors short term and long term strategies* Detailed insights on emerging regions procedure type, technology, with qualitative and quantitative information and facts

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Target Audience:* Preimplantation Genetic Testing Device Manufacturers* Traders, Importers, and Exporters* Raw Material Suppliers and Distributors* Research and Consulting Firms* Government and Research Organizations* Associations and Industry Bodies

Research Methodology:The market is derived through extensive use of secondary, primary, in-house research followed by expert validation and third party perspective, such as, analyst reports of investment banks. The secondary research is the primary base of our study wherein we conducted extensive data mining, referring to verified data sources, such as, white papers, government and regulatory published articles, technical journals, trade magazines, and paid data sources.

For forecasting, regional demand & supply factors, recent investments, market dynamics including technical growth scenario, consumer behavior, and end use trends and dynamics, and production capacity were taken into consideration. Different weightages have been assigned to these parameters and quantified their market impacts using the weighted average analysis to derive the market growth rate.

The market estimates and forecasts have been verified through exhaustive primary research with the Key Industry Participants (KIPs), which typically include:* Manufacturers* Suppliers* Distributors* Government Body & Associations* Research InstitutesAbout UsOrian Research is one of the most comprehensive collections of market intelligence reports on the World Wide Web. Our reports repository boasts of over 500000+ industry and country research reports from over 100 top publishers. We continuously update our repository so as to provide our clients easy access to the worlds most complete and current database of expert insights on global industries, companies, and products. We also specialize in custom research in situations where our syndicate research offerings do not meet the specific requirements of our esteemed clients.Contact Us:Ruwin MendezVice President Global Sales & Partner RelationsOrian Research ConsultantsUS: +1 (415) 830-3727 | UK: +44 020 8144-71-27Email: [emailprotected]

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Global Preimplantation Genetic Testing Market Size, by Procedure Type (Preimplantation Genetic Screening), by Technology (Next-Generation Sequencing,...

Global Predictive Genetic Testing market research report offers a complete analysis of the market size, market segmentation, and market growth factors. In addition, the Predictive Genetic Testing market report comprises the momentous data about the market drivers, restraints, and various factors such as changing manufacturing costs, research and development expenses, and operational difficulties. Moreover, the Predictive Genetic Testing research report delivers a broad study regarding the development in economic growth, technological advancements, as well as an extensive valuation of the technology providers.

Top Leading Key Players are: Agilent, Technologies, Inc., BGI Genomics, F.Hoffman-La Roche Ltd., Genes In Life., Invitae Corporation, Illumina, Inc., 23andMe, Myriad Genetics, Inc., Pathway Genomics and Thermo Fisher Scientific, Inc.

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In addition, report on global Predictive Genetic Testing market presents strategic analysis and ideas for new entrants using historic data study. Thus report provides estimation about the market size, revenue, sales analysis and opportunities based on the past data for current and future market status. Report covers analysis of different enterprises as part of global Predictive Genetic Testing market. There are some important tools for any market movement. Also report forecasts the market size of global Predictive Genetic Testing market in Compound Annual Growth Rate in terms of revenue during the forecast period.

The company profiles also covers the detailed description and segmentation of the companies along the finances which are being covered for the company. The global Predictive Genetic Testing market is likely to provide insights for the major strategies which is also estimated to have an impact on the overall growth of the market. Several strategies such as the PESTEL analysis and SWOT analysis is also being covered for the global market. These strategies have an impact on the overall market. Furthermore, several factors such as the emergence of new opportunities is also likely to boost the growth of the market.

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Likewise, the study also analyses numerous factors that are influencing the Predictive Genetic Testing market from supply and demand side and further evaluates market dynamics that are impelling the market growth over the prediction period. In addition to this, the target market report provides inclusive analysis of the SWOT and PEST tools for all the major regions such as North America, Europe, Asia Pacific, and the Middle East and Africa. The report offers regional expansion of the industry with their product analysis, market share, and brand specifications. Furthermore, the Predictive Genetic Testing market study offers an extensive analysis of the political, economic, and technological factors impelling the growth of the global Predictive Genetic Testing market across these economies.

A qualitative and quantitative analysis of the Predictive Genetic Testing market valuations for the expected period is presented to showcase the economic appetency of the global Predictive Genetic Testing industry. In addition to this, the global research report comprises significant data regarding the market segmentation which is intended by primary and secondary research methodologies. This research report offers an in-depth analysis of the global Predictive Genetic Testing industry with recent and upcoming market trends to offer the impending investment in the Predictive Genetic Testing market. The report includes a comprehensive analysis of the industry size database along with the market prediction for the mentioned forecast period. Furthermore, the Predictive Genetic Testing market research study offers comprehensive data about the opportunities, key drivers, and restraints with the impact analysis.

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Global Predictive Genetic Testing Market Size, Share, Types, Products, Trends, Growth, Applications and Forecast 2020 to 2025 - Germany English News

Michelle Kuppersmith's doctor recommended a bone marrow biopsy after suspecting she had a rare blood disorder. Though the biopsy was done by an in-network provider at an in-network hospital, Kuppersmith learned she was on the hook for $2,400 for out-of-network genetic profiling. Shelby Knowles for KHN hide caption

Michelle Kuppersmith's doctor recommended a bone marrow biopsy after suspecting she had a rare blood disorder. Though the biopsy was done by an in-network provider at an in-network hospital, Kuppersmith learned she was on the hook for $2,400 for out-of-network genetic profiling.

Michelle Kuppersmith feels great, works full time and exercises three to four times a week. So she was surprised when a routine blood test found that her body was making too many platelets, which help control bleeding.

Kuppersmith's doctor suspected the 32-year-old Manhattanite had a rare blood disorder called essential thrombocythemia, which can lead to blood clots, strokes and, in rare cases, leukemia.

Her doctor suggested a bone marrow biopsy, in which a large needle is used to suck out a sample of the spongy tissue at the center of the patient's hip bone.

Doctors examine the bone marrow under a microscope and analyze the DNA. The procedure allows doctors to judge a patient's prognosis and select treatment, if needed. Kuppersmith had heard the procedure can be intensely painful, so she put it off for months.

The biopsy performed by a provider in her insurance network, at a hospital in her network lasted only a few minutes, and Kuppersmith received relatively good news.

While a genetic analysis of her bone marrow confirmed her doctor's suspicions, it showed that the only treatment she needs, for now, is a daily, low-dose aspirin. She will check in with her doctor every three to four months to make sure the disease isn't getting worse.

All in all, Kuppersmith felt relieved.

Then she got a notice saying her insurer refused to pay for the genetic analysis, leaving her responsible for a $2,400 payment.

The patient: New York resident Michelle Kuppersmith, 32, who is insured by Maryland-based CareFirst Blue Cross Blue Shield. She works as director of special projects at a Washington-based watchdog group. Because she was treated in New York, Empire Blue Cross Blue Shield which covers that region handled part of her claim.

Total amount owed: $2,400 for out-of-network genetic profiling

The providers: Kuppersmith had her bone marrow removed at the Mount Sinai Ruttenberg Treatment Center in New York City, which sent her biopsy sample to a California lab, Genoptix, for testing.

Medical services: Bone marrow biopsy and molecular profiling, which involves looking for genetic mutations

What gives: The field of molecular diagnostics, which includes a variety of gene-based testing, is undergoing explosive growth, said Gillian Hooker, president of the National Society of Genetic Counselors and vice president of clinical development for Concert Genetics, a health IT company in Nashville, Tennessee.

A report from Concert Genetics, a company that helps clients manage genetic testing, found there are more than 140,000 molecular diagnostic products on the market, with 10 to 15 added each day.

The field is growing so quickly that even doctors are struggling to develop a common vocabulary, Hooker said.

Kuppersmith underwent a type of testing known as molecular profiling, which looks for DNA biomarkers to predict whether patients will benefit from new, targeted therapies. These mutations aren't inherited; they develop over the course of a patient's life, Hooker said.

Medicare spending on molecular diagnostics more than doubled from 2016 to 2018, increasing from $493 million to $1.1 billion, according to Laboratory Economics, a lab industry newsletter.

Charges range from hundreds to thousands of dollars, depending on how many genes are involved and which billing codes insurers use, Hooker said.

Based on Medicare data, at least 1,500 independent labs perform molecular testing, along with more than 500 hospital-based labs, said Jondavid Klipp, the newsletter's publisher.

In a fast-evolving field with lots of money at stake, tests that a doctor or lab may regard as state-of-the-art an insurer might view as experimental.

Worse still, many of the commercial labs that perform the novel tests are out-of-network, as was Genoptix.

Stephanie Bywater, chief compliance officer at NeoGenomics Laboratories, which owns Genoptix, said that insurance policies governing approval have not kept up with the rapid pace of scientific advances. Kuppersmith's doctor ordered a test that has been available since 2014 and was updated in 2017, Bywater said.

Although experts agree that molecular diagnostics is an essential part of care for patients like Kuppersmith, doctors and insurance companies may not agree on which specific test is best, said Dr. Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society.

Tests "can be performed a number of different ways by a number of different laboratories who charge different amounts," Nichols said.

Insurance plans are much more likely to refuse to pay for molecular diagnostics than other lab tests. Laboratory Economics found Medicare contractors denied almost half of all molecular diagnostics claims over the past five years, compared with 5-10% of routine lab tests.

With so many insurance plans, so many new tests and so many new companies, it is difficult for a doctor to know which labs are in a patient's network and which specific tests are covered, Nichols said.

"Different providers have contracts with different diagnostic companies," which can affect a patient's out-of-pocket costs, Nichols said. "It is incredibly complex and really difficult to determine the best, least expensive path."

Kuppersmith said she has always been careful to check that her doctors accept her insurance. She made sure Mount Sinai was in her insurance network, too. But it never occurred to her that the biopsy would be sent to an outside lab or that it would undergo genetic analysis.

She added: "The looming threat of a $2,400 bill has caused me, in many ways, more anxiety than the illness ever has."

The resolution: Despite making dozens of phone calls, Kuppersmith got nothing but confusing and contradictory answers when she tried to sort out the unexpected charge.

An agent for her insurer told her that her doctor hadn't gotten preauthorization for the testing. But in an email to Kuppersmith, a Genoptix employee told her the insurance company had denied the claim because molecular profiling was viewed as experimental.

A spokesperson for New York-based Empire Blue Cross Blue Shield, which handled part of Kuppersmith's claim, said her health plan "covers medically necessary genetic testing."

New York, one of 28 states with laws against surprise billing, requires hospitals to inform patients in writing if their care may include out-of-network providers, said attorney Elisabeth Benjamin, vice president of health initiatives at the Community Service Society, which provides free help with insurance problems.

A spokesperson for Mount Sinai said the hospital complies with that law, noting that Kuppersmith was given such a document in 2018 nearly one year before her bone marrow biopsy and signed it.

Benjamin said that's not OK, explaining: "I think a one-year-old, vague form like the one she signed would not comply with the state law and certainly not the spirit of it."

Instead of sending Kuppersmith a bill, Genoptix offered to help her appeal the denied coverage to CareFirst. At first, Genoptix asked Kuppersmith to designate the company as her personal health care representative. She was uncomfortable signing over what sounded like sweeping legal rights to strangers. Instead, she wrote an email granting the company permission to negotiate on her behalf. It was sufficient.

A few days after being contacted by KHN, Kuppersmith's insurer said it would pay Genoptix at the in-network rate, covering $1,200 of the $2,400 charge. Genoptix said it has no plans to bill Kuppersmith for the other half of the charge.

The takeaway: Kuppersmith is relieved her insurer changed its mind about her bill. But, she said: "I'm a relatively young, savvy person with a college degree. There are a lot of people who don't have the time or wherewithal to do this kind of fighting."

Patients should ask their health care providers if any outside contractors will be involved in their care, including pathologists, anesthesiologists, clinical labs or radiologists, experts said. And check if those involved are in-network.

"Try your best to ask in advance," said Jack Hoadley, a research professor emeritus at Georgetown University. "Ask, 'Do I have a choice about where [a blood or tissue sample] is sent?'"

Ask, too, if the sample will undergo molecular diagnostics. Since the testing is still relatively new and expensive most insurers require patients to obtain "prior authorization," or special permission, said Dr. Debra Regier, a medical geneticist at Children's National Hospital in Washington and an associate with NORD, the National Organization of Rare Diseases. Getting this permission in advance can prevent many headaches.

Finally, be wary of signing blanket consent forms telling you that some components of your care may be out-of-network. Tell your provider that you want to be informed on a case-by-case basis when an out-of-network provider is involved and to consent to their participation.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have a perplexing medical bill you want to share with us? Tell us about it here.

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Bill Of The Month: Pricey Genetic Test For Essential Thrombocythemia : Shots - Health News - NPR

This is a very exciting era in laboratory medicine as virtually every day new genetic tests and emerging laboratory technologies enter the market. With these advancements also comes the (fun) challenge of distinguishing clinical testing from research testing. Making this distinction matters in two key ways. First, from a regulatory standpoint, it would be financially irresponsible to bill patients and insurers for research testing. Second, in terms of clinical implications, we have to demonstrate the value of classifying variants (clinical validity), then show that variant classification impacts patient clinical outcomes (clinical utility). Laboratory test stewardship programs provide an important foundation for striking an appropriate balance between implementing new genetic tests and meeting standards for clinical validity and utility, paying particular attention to the size of genetic panels.

Since the 1980s, identification of genetic markers has supported tailored clinical diagnoses and therapies, and as such, genetic testing has become an attractive diagnostic tool. Single gene testing has progressed to more expansive gene panels, exome, and even genome sequencing. While novel technologies provide the potential for increased efficiency, more comprehensive analysis, and reduced invasive testing to guide clinical care, the financial impact and potential secondary findings of these methods necessitate a balanced approach to responsibly implement precision medicine in clinical practice.

To be good laboratory testing stewards, we must address questions about the value of new and emerging technologies. Simply defined, value is the quality of a test divided by its cost. While mathematical equations are straightforward precisely because they are objective, the perspective of value varies for each stakeholder (patients, providers, laboratorians, and payers), and these perspectives often have competing interests.

A crucial consideration is the timeline in which novel technologies are implemented clinically and, perhaps even more challenging, the elements that distinguish research testing from clinical testing. Clinical testing (for all laboratory tests) encompasses analytical validity, clinical validity, and demonstrated clinical utility. In some cases, genetic tests are Food and Drug Administration (FDA)-cleared for specific clinical applications. Patients and insurers typically are responsible for the cost of clinical testing. As new assays appear on the market, they might demonstrate analytical validity, but lack evidence establishing clinical validity and utility.

Requiring patients or insurers to cover the cost of building this evidence for a new assay is contrary to laboratory stewardship principles. Lab stewards have the difficult task of distinguishing true research from ancillary testing. Advancing research and providing evidence of clinical validity and clinical utility remain critical for enhancing our overall understanding of genetic testing. One approach to balancing both needs is to find alternative funding for clinical research in order to achieve alignment with insurers while also supporting patients.

It goes without saying that strict standards for validation and documentation exist for clinical testing, and although only a minority of tests are FDA-cleared, all laboratory developed tests must adhere to CLIA regulations. This is a minimum standard; even laboratories that perform research-use only testing and return results to participants must have a CLIA license. Compliance with CLIA regulations is not the only factor in assessing a laboratorys or tests quality. Evaluating a laboratorys comprehensive services also matters, including its result reporting processes, adherence to professional society guidelines, report formatting, test billing, and sample coordination logistics.

When adopting new genetic tests, a second consideration is the size of a panel. A bigger panel with more genes or genetic markers does not necessarily improve diagnostic clarity. With an increased number of assayed genes comes greater potential for variants of uncertain significance (VUS). These variants can be particularly challenging because genomics is still relatively new and we collectively lack sufficient data to confidently classify variants as pathogenic or benign. In the absence of evidence supporting these classifications, laboratories assign variants to a VUS holding cell category. Once sufficient evidence arises, variants originally classified as VUS will be upgraded (to pathogenic or likely pathogenic) or downgraded (to benign or likely benign).

One would predict that approximately half of all VUS would be upgraded and half downgraded. However, in what is termed the VUS paradox, there is significant discordance between the expected and observed reclassification of variants. It is much more common for VUS to be reclassified as benign or likely benign (downgraded) than to be upgraded (1). Given the large body of evidence demonstrating that VUS can cause patient harm, labs act irresponsibly if they inappropriately classify variants as VUS. As laboratory stewards, we need to ensure that any gene panel ordered is the best fit for the clinical question at hand instead of using an inappropriately large gene panel likely to result in challenging VUS.

From the perspectives of patients and insurers, it is critical to demonstrate how outcomes will improve as a result of using this new technology. Are these new tests preforming better than current standard of care? In many cases, additional evidence is needed before a test is offered broadly. The following examples in cancer and prenatal settings highlight the promise of novel technologies and questions that should be considered before adopting/implementing more broadly.

Cell-free DNA screening was launched in 2012 and meta-analyses have demonstrated superior performance for detecting chromosomal aneuploidies such as Down syndrome relative to existing maternal serum screening tests like the combined and fully integrated screening tests. Since then, cell-free DNA prenatal screening has expanded rapidly, including the recent ability to detect all aneuploidies and even sub-chromosomal copy number alterations such as microdeletions and microduplications.

From a consumer perspective, cell-free DNA prenatal screening is appealingits less invasive than diagnostic testing like amniocentesis and can reveal a babys sex in the first trimester of pregnancy. However, this new modality remains a screening test and actually can complicate decision-making when used as a diagnostic test. This is because it tests both maternal and fetal cell-free DNA and uncovers findings that can be difficult to interpret.

For example, numerous cases have been reported of detecting unknown maternal cancer, which is called occult maternal malignancy. If a cell-free DNA prenatal screen identifies a potential maternal cancer, the affected patient necessarily will embark on a diagnostic hunt for a tumor during an already difficult period of pregnancy. This can be challenging from an insurers perspective as well because finding a tumor based on cell-free DNA prenatal screening results might necessitate expensive imaging studies.

While there is great promise in expanding the technology of cell-free DNA to detect single-gene Mendelian disorders, the American College of Obstetricians and Gynecologists has issued a practice advisory that, there has not been sufficient information regarding accuracy and positive and negative predictive value ... [and thus,] single-gene cell-free DNA screening is not currently recommended in pregnancy (2).

The pace at which new technology is being developed and implemented in clinical settings will undoubtedly stay in the fast lane. As such, laboratorians need to consider how to best integrate novel technologies into clinical practice (or not), striking a responsible balance between true clinical research and ancillary testing.

Using alternate funding sources for clinical research, including risk-sharing partnerships with insurers, has proven successful and may pave the way for clinical research to become true clinical testing. Practice guidelines are extremely valuable but often lag behind advances in technology precisely because they require a high burden of published evidence. An institutional approach utilizing an oversight committee, such as a laboratory stewardship committee, is an effective vehicle for evaluating implementation of new technologies and shifting appropriately from research to clinical testing when sufficient evidence exists for clinical validity and utility.

The genomic testing era is very exciting, and responsibly implementing a collaborative stewardship program is critical for ensuring that we offer the right test to the right patient at the right time.

Tina Lockwood, PhD, DABCC, DABMGG, is an associate professor in the department of laboratory medicine and director of the genetics and solid tumor diagnostics laboratory at the University of Washington in Seattle.+Email: tinalock@uw.edu

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Lab Stewardship in the Era of Genomic Testing - American Association for Clinical Chemistry (AACC)

LOS ANGELES (CBSLA) A settlement has been reached with a Chinese genetic testing company over allegations it advertised and sold at-home COVID-19 testing kits that lacked FDA approval.

Los Angeles City Attorney Mike Feuer filed suit against Yikon Genomics, seeking a court order that directs the company to stop marketing and selling the test kits plus fines for each alleged violation. Feuer announced Monday it had reached a settlement with the company.

Yikon Genomics had touted a $39 test that promised to deliver a result in 15 minutes. The company claimed the Corona Virus At-Home Test Kit was approved by the U.S. Food and Drug Administration.

The FDA has not approved any coronavirus home test kits.

If consumers have a home test kit that hasnt been approved by the FDA, and is not likely to work properly, they might not get reliable results, and they might unknowingly expose others to this virus, Feuer said at a news conference.

Yikon Genomics, which primarily does genetic and in-vitro fertilization testing, agreed to pull its product from the market and refund anyone who purchased it.

The coronavirus outbreak and inability for most people to obtain a test has given rise to a number of coronavirus-related scams, including ones related to stimulus checks, donations, investments, inspections and fake home tests.

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LA City Attorney Settles With Chinese Genetic Company Over COVID-19 Home Test Claiming To Have FDA Approval - CBS Los Angeles

Dublin, April 06, 2020 (GLOBE NEWSWIRE) -- The "U.S. Hematologic Malignancies Testing Market: Focus on Product, Disease, Technology, End User, Country Data and Competitive Landscape - Analysis and Forecast, 2018-2025" report has been added to ResearchAndMarkets.com's offering.

This report projects the market to grow at a significant CAGR of 14.60% during the forecast period, 2019-2025. The U.S. hematologic malignancies market generated $723.9 million revenue in 2018, in terms of value.

The U.S. hematologic malignancies market growth has been primarily attributed to the major drivers in this market, such as rising incidence of hematologic malignancies, favorable reimbursement scenario, and increase in funding in the hematologic malignancies market. However, there are factors hindering the growth of the market, such as lack of training professionals, high pricing pressure, and issue pertaining to the analytic validity of genetic testing.

Key Questions Answered in this Report:

Market Segmentation

Key Companies in the U.S. Hematologic Malignancies Market

The key manufacturers that have been contributing significantly to the U.S. hematologic malignancies market include Abbott Laboratories, Illumina, Inc., F. Hoffmann-La Roche Ltd, Bio-Rad Laboratories, Inc., Sysmex Corporation, Cancer Genetics Inc., QIAGEN N.V., ICON plc, Quest Diagnostics Incorporated, Invitae Corporation, Opkp Health, Laboratory Corporation of American Holdings, NeoGenomics Laboratories, Inc., ASURAGEN, INC., ArcherDX, Inc., Adaptive Biotechnologies, ARUP Laboratories, and Invivoscribe, Inc, among others.

Key Topics Covered:

1 Product Definition

2 Market Scope

3 Research Methodology

4 Epidemiology of Hematological Malignancies in U.S.

5 U.S. Hematologic Malignancies Testing Market: Value and Volume Data 2019 (U.S. State Regions)5.1 Midwest U.S.5.2 Mid Atlantic5.3 The Southwest5.4 New England5.5 The West5.6 The South

6 Market Dynamics6.1 Market Drivers6.1.1 Rising Incidence of Hematologic Malignancies6.1.2 Increasing Adoption of Inorganic Growth Strategies in the Market6.1.3 Favorable Reimbursement Scenario in the U.S. hematologic Malignancies Testing Market6.1.4 Increase in Funding in Hematologic Malignancies Testing Market6.2 Restraints6.2.1 High Pricing Pressure6.2.2 Lack of Trained Professionals6.2.3 Issues Pertaining to the Analytical Validity of Genetic Testing for Cancers6.3 U.S. Market Opportunities6.3.1 An Underlying Relaxation in Revised 2018 PAMA Criteria6.3.2 Informatics and Technological Innovation for Larger Consumer Base6.3.3 Technological Advancements in the Field of Molecular Diagnostics

7 Competitive Landscape7.1 Key Strategies and Developments7.1.1 Synergistic Activities7.1.2 Approvals7.1.3 Product Launches and Enhancements7.1.4 Merger, Acquisitions & Expansions7.2 Product Scenario7.3 Funding Scenario7.4 Market Share Analysis7.5 Growth Share Analysis (Opportunity Mapping)7.5.1 By Company7.5.2 By Product

8 Industry Insights8.1 Regulatory Framework8.1.1 Legal Requirements and Framework in the U.S.8.2 Reimbursement Scenario8.2.1 Protecting Access to Medicare Act (PAMA) Criteria for Advanced Diagnostic Laboratory Tests (ADLT)8.3 Physicians' Perceptions

9 U.S. Hematologic Malignancies Testing Market (by Product) 2018-2025 ($ Million)9.1 Services9.2 Kits9.2.1 NGS-Based Gene Panels9.2.1.1 Leukemia9.2.1.2 Lymphoma9.2.1.3 Multiple Myeloma9.2.1.4 Myeloproliferative Neoplasms9.2.1.5 Myelodysplastic Syndromes9.2.2 NGS-Based Molecular Clonality Testing9.2.2.1 Leukemia9.2.2.2 Lymphoma9.2.2.3 Multiple Myeloma9.2.2.4 Myeloproliferative Neoplasms9.2.2.5 Myelodysplastic Syndromes9.2.3 NGS-Based Translocation Testing9.2.3.1 Leukemia9.2.3.2 Lymphoma9.2.3.3 Multiple Myeloma9.2.3.4 Myeloproliferative Neoplasms9.2.3.5 Myelodysplastic Syndromes9.2.4 NGS-Based Mutation Testing9.2.4.1 Leukemia9.2.4.2 Lymphoma9.2.4.3 Multiple Myeloma9.2.4.4 Myeloproliferative Neoplasms9.2.4.5 Myelodysplastic Syndromes9.2.5 NGS-Based Minimal Residual Disease (MRD) Testing9.2.5.1 Leukemia9.2.5.2 Lymphoma9.2.5.3 Multiple Myeloma9.2.5.4 Myeloproliferative Neoplasms9.2.5.5 Myelodysplastic Syndromes

10 U.S. Hematologic Malignancies Testing Market (by End User)10.1 Specialty Clinics and Hospitals10.2 Diagnostic Laboratories10.3 Reference Laboratories10.4 Research Institutions

11 U.S. Hematologic Malignancies Testing Market (by Disease)11.1 Leukemia11.2 Lymphoma11.3 Multiple Myeloma11.4 Myeloproliferative Neoplasms11.5 Myelodysplastic Syndromes

12 U.S. Hematologic Malignancies Testing Market (by Technology)12.1 Next-generation Sequencing (NGS)12.2 Polymerase Chain Reaction (PCR)12.3 Fluorescence In-Situ Hybridization (FISH)12.4 Immunohistochemistry (IHC)12.5 Flow Cytometry12.6 Other Technologies

13 Company Profiles

Story continues

Companies Mentioned

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United States Hematologic Malignancies Testing Industry (2018 to 2025) - Featuring Illumina, Invitae Corporation & Invivoscribe Among Others -...

Unlike some countries, we didnt go into this crisis with a huge diagnostics industry. We have the best scientific labs in the world, but we did not have the scale, Matt Hancock said this week, facing a barrage of questions on why the UK is lagging behind others on coronavirus testing.

The UKs health secretary said his German counterpart could call on 100 test labs and rely on the heavy presence of Roche, one of the worlds largest diagnostics companies, to achieve its current level of more than 50,000 tests a day. The UK had had to build from a lower base, he said.

Industry players say this is a fair characterisation. We have a lot of diagnostics capability in this country but what we dont have is the global diagnostics giants, said Tony Cooke of Cambridge Clinical Laboratories. Even when we have our own companies, a lot of the supplies are coming from the US or Germany.

The UK is not alone in struggling to meet demand. France has carried out even fewer tests than the UK, and Spain tried to bridge supply chain issues by buying millions of test kits from China that later had to be withdrawn after giving flawed results.

As well as Roche, which has developed a single machine that can churn out 1,000 test results a day, Germany also has Qiagen, a major supplier of genetic testing kits, which are being used to diagnose Covid-19. Both companies also produce reagents and components used in kits put together by other manufacturers. The US has called on Abbott, Thermofisher, Quest Diagnostics and Hologic.

The more distributed hospital lab system in countries such as Germany and Italy has also served them well in being able to increase testing for Covid-19. The NHS has spent years centralising its testing labs, which under normal circumstances was both economical and clinically robust. It has allowed labs to be aligned to standard diagnostic criteria and to use the same test kits, reagents and equipment from the same suppliers, allowing bulk purchases from single suppliers at a competitive price.

During a pandemic, however, this dependency on a handful of non-domestic suppliers, such as Roche, for kits and reagents becomes a fundamental flaw.

Allan Wilson, the president of the Institute of Biomedical Science, says the UK could have done a better job of surveying its diagnostic landscape and built a strategy around existing strengths, which include having a large number of research labs and smaller, but highly innovative diagnostics companies.

The re-engineering of HIV testing machines into 90-minute Covid-19 tests by Diagnostics for the Real World in Cambridge, which within a week will meet the entire testing requirements of Addenbrookes hospital in the city, is an example of the type of approach that could have been encouraged nationally.

We were slow to make that decision in testing and we approached it in too narrow a perspective, said Wilson. Were doing it regional locally, people forming and forging partnership arrangements, looking for support from universities and commercial companies.

Industry figures say that more could be done in future to nurture some of these startups and medium-sized companies into home-grown giants.

There is a record to show that innovative businesses started in the UK have this potential, but that beyond a certain level of success the companies tend to migrate to the US where venture capital and buyers are in more ready supply.

Medisense, which was spun out of Oxford University in the 1990s, revolutionised the blood glucose sensing industry in the 1990s, then was acquired by the US company Abbott. Solexa, a genetic sequencing company spun out of Cambridge, was acquired by Illumina in the US for about $650m in 2007 and is now worth about $40bn.

Gordon Sanghera, the chief executive of the sequencing and diagnostics company Oxford Nanopore, whose technology was used to characterise the very first example of the coronavirus in Wuhan, said Hancocks acknowledgement of the need to nurture a domestic industry was welcome and should not be forgotten after the crisis has passed.

Hancocks declaration that the UK needs a new diagnostic industry is right, and we have plenty of seeds, he said. Its the collaboration with the broader scientific community, and looking at access to capital for UK companies, that will make those seeds grow and bear fruit that helps people not only in the UK, but all around the world.

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Why has the UK lagged behind in testing for the coronavirus? - The Guardian