Boston startup Orig3n logged hundreds of false-positives as it processed COVID-19 tests for dozens of Massachusetts long-term care facilities. According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

A Boston consumer genetics company that has batted away former employees accusations of shoddy practices since at least 2019 is now under investigation by the state Department of Public Health for logging hundreds of false positive coronavirus test results.

The company, Orig3n, has halted COVID-19 testing in the state. A company spokesman said the false positives were due to "human error" in processing the tests.

In August, after learning about the Massachusetts investigation, North Carolina issued a stop order for its coronavirus testing contract with Orig3n.

The consumer genetics startup, which claims it can tell customers what kind of foods they should eat and whether theyre predisposed to intelligence based on their DNA, has secured some of the biggest coronavirus testing contracts in the country.

According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

So far, the Massachusetts DPH has found Orig3n sent out more than 300 COVID-19 tests wrongly classified as positive in Massachusetts, a number that could increase as DPH staff continue investigating. Orig3n claims the company isnt aware of any additional false positives. According to a Harvard epidemiologist and lab director, false negatives are far more difficult to discover, because most tests come back as negative.

Ted Owens, CEO at North Hills Pines Edge skilled nursing facility in Needham, one of roughly 60 long-term care facilities that used Orig3n test services, said in an Aug. 11 bulletin to residents and staff that Orig3n returned a total of 19 false positives to the nursing home.

The numbers didnt seem credible to Owens, but Pines Edge began immediately to take actions based on the working assumption that we needed to treat these results as correct.

It turned out that several other skilled nursing facilities also showed an unusual spike in positive cases last week, and oddly enough, all these facilities had used the same testing vendor, Owens continued. This caught the attention of the epidemiologists at Mass DPH, who intervened and instructed the vendor to re-test the samples."

Upon retesting, all of the positive tests were found to be negative.

The spike in cases which turned out to be false positives caused panic in Needham. They came as the school district made plans to return to in-person learning, and a public health nurse for the town was asked to appear before the Select Board.

Needham public health nurse Tiffany Zike told the board on Aug. 18 that a number of coronavirus cases reported in July were considered false cases that were revoked due to the lab having an issue.

$25,000 wire transfer

In early May, nursing homes throughout Massachusetts were looking for a miracle.

The DPH had ordered long-term care facilities coping with severe coronavirus outbreaks to test 90% of residents and staff for COVID-19 by May 25 in order to qualify for a portion of $130 million in relief funding offered by the state.

Many nursing homes struggled to meet the deadline because of a shortage of COVID-19 tests. The National Guard was testing nursing home residents and staff on behalf of the state, but demand was high.

When Ron Doty got a memo from the Massachusetts Senior Care Association on May 6 offering Orig3n as a turnkey mobile testing option, he immediately reached out to the company.

Doty, administrator at Marlborough Hills Rehabilitation & Health Care Center in Marlborough, wired $25,000 to Orig3n. The next day, he received 250 COVID-19 test kits from the company.

Two months later, Orig3n was asked to suspend COVID-19 testing in Massachusetts, which it did on Aug. 8. Staff at the DPH noticed the lab was reporting an unusually high rate of positive tests, prompting the agency to investigate, according to a DPH spokesperson.

The state DPH declined to identify which nursing homes used Orig3ns testing services, citing the ongoing investigation.

Tony Plohoros, Orig3ns spokesman, said the lab is now working with state health officials to correct problems in its Boston lab, which has ceased processing coronavirus samples but continues to process consumer genetic profiles.

While it remains unclear if the federal government has taken action to halt use of Orig3ns COVID-19 testing services in other parts of the country, as North Carolina did, concerns about Orig3n hadnt yet reached a health care supply company in Ohio as of this week. That company, Mason, Ohio-based Link-age Solutions, is still working with Orig3n to provide coronavirus tests to long-term care facilities nationwide.

Patrick Schwartz, a spokesman for Link-age Solutions, said Thursday that the company was unaware Orig3n was asked to cease coronavirus testing in Massachusetts.

One of the highest accuracy ratings in the market

Orig3n received an emergency authorization to conduct COVID-19 testing from the Food and Drug Administration in April.

The same month, the company received a federal Paycheck Protection Program loan valued between $350,000 and $1 million from Silicon Valley Bank, according to U.S. Treasury data.

Since getting the FDA approval, Orig3n has provided testing services to The New England Power Generators Association, Bostons homeless population, a boarding school in Virginia and other public and private entities.

In late June, Link-age Solutions, which helps long-term care facilities nationwide obtain supplies ranging from pharmaceuticals to office supplies, issued a press release touting Orig3ns breakthrough testing method as having one of the highest accuracy ratings in the market.

In partnering with Orig3n, Link-age could offer in-demand coronavirus tests to its members at a reduced cost, according to the press release. Results would be returned less than 36 hours after specimens arrived at the lab, the release said.

The lab boasts output capabilities of 6,000 and up to 12,000 tests per day, and will offer billing to Medicare where appropriate, the press release stated. Reporters questions to the Centers for Medicare & Medicaid Services have gone unanswered.

Schwartz, the Link-age spokeman, said Thursday his company continues to offer COVID-19 testing services performed by Orig3n, and that feedback about Orig3ns tests from its customers has been positive.

Company flagged in the past

Orig3n lists its office location as the third floor of 27 Drydock Ave. in the heart of Bostons Seaport neighborhood. Until August, thats where the company processed its coronavirus tests.

Before it got into the coronavirus business, Orig3n billed itself as a consumer genetics pioneer, carving a path toward a future of wellness and health through the use of diagnostics, genetics and biotechnology.

The company, founded in 2014, offers tests ranging in cost from $29 to $298 that are supposed to help people learn what kinds of food, exercise and beauty products would work best for their genetic profiles, and even whether they are genetically predisposed to so-called superhero traits including intelligence and strength, according to Bloomberg Businessweek.

A former Orig3n employee who spoke to Gannett New England reporters on the condition of anonymity because of a nondisclosure agreement with the company said the number one complaint received by customer service was genetic profile tests not being returned to customers. The employee, who left the company pre-pandemic, didnt think the company could handle both genetic profile testing and coronavirus testing.

Unless things drastically changed since I have left, not even testing, just bandwidth-wise, they were already kind of drowning when I left, the employee said.

Despite its startup status, Orig3n quickly gained prominence partly through securing big-name partnerships, including one with the NFLs Baltimore Ravens.

In September 2017, the Ravens linked up with Orig3n for an event called DNA Day. Roughly 70,000 Ravens fans were set to pour into the teams stadium, where they could have picked up a free genetic testing kit.

The event never happened. The Ravens postponed it days before federal health officials told The Baltimore Sun they were working to determine whether any of the testing being offered by Orig3n is subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988.

The federal regulatory standards apply to labs testing human samples in the United States, and are intended to ensure accuracy, effectiveness and reliability.

About a year after DNA Day was scrapped, 17 former Orig3n employees criticized the company in Bloomberg Businessweek, alleging it habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards.

Marketing, not science, the employees said, was the companys priority.

Press releases put out by Orig3n throughout the pandemic show the company was eager to publicize contracts with respected institutions, both public and private.

On May 12, the company announced what it called a comprehensive solution to enable COVID-19 testing for Massachusetts nursing home residents.

In the press release, the company said it sought to become the partner of choice for coordinating and providing COVID-19 testing for defined populations beyond long-term care residents and employees, including private employers, schools, government agencies, and cities and states.

The nursing home program is one of many applications for Orig3ns fully-integrated solution, the press release said.

What went wrong?

Doty, the Marlborough nursing home administrator, would not have known about Orig3n if not for the May 6 memo from Massachusetts Senior Care Association, an organization many nursing homes relied on during the viruss spring surge in the state to interpret complex and shifting guidance from the DPH.

Massachusetts Senior Care Association President Tara Gregorio said in a statement that her organization essentially serves as a messenger for its members, and that it relies on governmental agencies to vet labs like Orig3n.

"Throughout the pandemic, MSCA has passed along lists of government approved COVID-19 PCR testing labs options available to our members, Gregorio wrote. We must rely, as all providers do, on the licensing process to ensure legitimacy and accuracy of these labs."

The FDA, which gave Orig3n emergency authorization to conduct coronavirus testing last spring, has not yet responded to Gannett New England reporters seeking comment.

According to a Massachusetts DPH spokesman, Orig3n told the agency after it was contacted by DPH that errors in testing occurred because of a broken vial or contaminated plate during final processing, an explanation DPH investigators are now trying to confirm.

In an email to Gannett New England reporters on Friday, Plohoros, Orig3ns spokesman, said human error at the beginning of the laboratory testing process caused a pre-extraction reagent that was used in the affected batch tests to become contaminated.

In an Aug. 18 press conference, Massachusetts Secretary of Health and Human Services Marylou Sudders said erroneous results from Orig3n affected the number of COVID-19 cases reported in Fall River and Taunton.

The positive test rates for that three-day period for that one lab just seemed high, and so (we) went back, and the lab stopped processing, they're still not processing any tests, Sudders said, adding that DPH staff was analyzing tests processed prior to the discovery to make sure the issue was, as Orig3n told the DPH, a one-time problem rather than a more structural issue.

Dr. Michael Mina is an assistant professor of epidemiology at Harvard T. H. Chan School of Public Health who has experience running laboratories that perform PCR testing.

Mina says a lab that processes 6,000 to 12,000 PCR coronavirus tests a day as Orig3n has said it does would need to be run with what he called extreme quality control measures.

It requires an amazing amount of concentration and care to really ensure you're not getting contamination or any number of other problems that can happen, he said. If this was an easy (test), I would have said, sure, any lab can do it but this particular (test) ... it really is a finicky test. You have to be extremely careful about how you're doing it, and that means you need a lot of quality controls. You need to be a really diligent lab.

Mina, who stressed he has no knowledge of Orig3n other than circulating allegations that the company had previously been investigated, said when a mistake like the kind Orig3n described occurs, staff should immediately stop processing, sterilize the area and alert any affected patients and health departments.

The fact that the Massachusetts DPH noticed the problem and not Orig3n is a problem, Mina said.

That shows in general that the quality control wasn't being maintained, he said, adding that performing intense quality control checks multiple times daily is a core tenet of running any lab, especially a high-complexity clinical lab. And if we're giving them the benefit of the doubt, they didn't know that there was a problem because otherwise it's just nefarious.

Mina said that a professionally run lab would likely have caught the mistake, and alerted the state DPH immediately.

Part of the reason for that is simply a motive to care for the patient, who will likely make important decisions about their own behavior based on the test result they receive, which in turn affect other people.

At Brigham, for example, where I was one of the medical directors, of course people feel embarrassed (about making a mistake), but there's this strong culture where people recognize that their embarrassment is not worth a patient's hardship, Mina said. That's one thing that really, I think, lacks a little bit when we move into industry laboratories running clinical tests. That same spirit of honesty ... might not exist everywhere.

While mistakes at labs are common, Mina said, they're also commonly fixed and they don't usually require an investigation.

Mina said that the U.S. did need to increase its capacity to process coronavirus tests this spring, but labs, especially ones new to the medical diagnostics space, as Orig3n is, need to be monitored closely.

It's just important to keep all these things in check, Mina said. The frenzy to do coronavirus testing has been so extreme. I don't think labs should be immediately shut down for mistakes, but we have to remain vigilant to ensure that all the testing that is being done is up to the highest standards.

Trevor Ballantyne and Jeannette Hinkle are reporters for Gannett New England.

Originally posted here:
The sudden spike in Mass. COVID-19 cases was jarring. Now, the company that did the tests is under investigation. - The Gardner News

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