CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Good Start Genetics, Inc.,an innovative molecular diagnostics company harnessing a powerful, proprietary next-generation DNA sequencing (NGS) capability, announced today that it has received a clinical laboratory permit from the New York State Department of Health to provide its GoodStart Select carrier screening tests to in-vitro fertilization (IVF) and other reproductive health practitioners in the state. GoodStart Select, the companys menu of carrier screening tests, detects far more disease-causing mutations than any other carrier screening test routinely used in clinical practice. With this license, Good Start becomes the first laboratory to offer extensively validated NGS-based carrier screening in New York, where nearly 25 percent of all reproductive health carrier screening is performed each year.

Couples planning to conceive want to make sure they have the healthiest pregnancy possible, said David L. Keefe, M.D., Stanley H. Kaplan Professor of Obstetrics and Gynecology and chair, Department of Obstetrics and Gynecology at NYU Langone Medical Center. Good Start's approach to pre-conceptual genetic testing draws on the latest technology developed from the Human Genome Project and delivers remarkable accuracy and sensitivity in the detection of genetic conditions that might afflict their baby.

We congratulate Good Start on being awarded its New York state license and look forward to offering the next generation of genetic testing to our patients, adds Alan Copperman M.D., co-director of Reproductive Medicine Associates of New York, vice chairman of the Department of Obstetrics, Gynecology, and Reproductive Science at Mount Sinai Medical Center, and long-standing adviser to Good Start Genetics.

GoodStart Select was launched in the U.S. in April 2012. Since then, Good Start Genetics high-complexity, CLIA- and CAP-accredited laboratory has processed well over 100,000 tests, detecting both common disease-causing mutations as well as rare, pathogenic mutations that would have otherwise gone undetected by laboratories using traditional genotyping-based technologies. Last week, Good Start Genetics published its comprehensive validation study in Genomics in Medicine.

In addition, Good Starts tests are clinically validated to detect genetic mutations specific to individuals of Ashkenazi Jewish or Eastern European descent. Nearly one in three Ashkenazi Jews in the U.S. is a carrier of at least one of 19 severe inherited diseases, and one-third of the U.S. Jewish population, the vast majority of which are Ashkenazi, resides in the state of New York.

Obtaining the New York state license is an important achievement for Good Start, and were very proud our operation has passed the rigorous New York inspection and approval process, said Don Hardison, president and chief executive officer of Good Start Genetics. We have seen strong adoption by reproductive health specialists across the country, and now look forward to providing our highly accurate and clinically actionable tests to physicians and patients in New York.

About GoodStart Select

GoodStart Select is Good Start Genetics menu of carrier screening tests that, for diseases such as cystic fibrosis, detects many more disease-causing mutations than any other routine carrier screening test, regardless of patient ethnicity. After years of development and rigorous validation, Good Start Genetics has harnessed the power of its sophisticated technologies, including next-generation DNA sequencing (NGS), to provide highly accurate and actionable tests resulting in higher mutation detection rates and fewer missed carriers. Good Start offers genetic screening tests for all disorders recommended by the American Congress of Obstetricians and Gynecologists (ACOG), the American College of Medical Genetics and Genomics (ACMG), and leading Jewish advocacy groups.

To support the companys gold standard genetic screening capabilities, Good Start has a dedicated team of customer care specialists, board certified medical geneticists and genetic counselors who provide step-by-step support, from test selection through results, analysis and reporting. For these reasons, reproductive health specialists and their patients can have the highest degree of confidence in their genetic carrier screening results.

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Good Start Genetics Receives Approval to Conduct Genetic Screening in New York

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