Montgomery Co. ends contract with lab providing COVID-19 tests

Officials in Montgomery County, Maryland, have terminated a contract with the genetic testing lab that had been providing coronavirus tests for county-run sites since May.

The cancellation of the county’s contract with Rockville-based AdvaGenix comes after the state issued an order barring the lab from processing the tests.

An inspection by state health officials turned up “deficient practices” that called into question thousands of tests, according to the Maryland Department of Health.

Montgomery County had suspended all testing at county-run testing sites Aug. 14.

A news release from the county posted Tuesday said officials there are now working to reopen testing sites with the help of the state health department, which it said has committed to replace the weekly supply of tests for the next four weeks.

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Residents who are experiencing COVID-19 symptoms are still able to schedule an appointment for a test by calling the county’s testing helpline at (240) 777-1755.

Word of possible issues with the AdvaGenix tests first came to light last week, when Montgomery County suspended operations at two of its testing sites.

On Friday, Maryland’s Office of Healthcare Quality issued a cease-and-desist order, barring AdvaGenix from processing COVID-19 tests and ordering it to notify all patients whose tests it had processed that the results of those tests are “erroneous or questionable.”

AdvaGenix: Tests are ‘safe and accurate’

The exact issue uncovered by inspectors is still unknown. The state health department said the inspection was triggered by a complaint and revolved around “pre-analytic deficiencies that may have affected sample integrity.”

In a statement Tuesday afternoon, AdvaGenix CEO Dr. William Kearns insisted the company’s tests are “safe and accurate,” and that the matter stemmed from a regulatory disagreement.

“It’s unfortunate that the county has taken this action when we expect a swift resolution to the regulatory issues in question,” Kearns said in the statement. “AdvaGenix’s COVID-19 tests are safe and accurate. We have fully cooperated with federal, state and local officials at every step in this process. AdvaGenix wants to resolve this dispute as quickly as possible and get back to the important work of helping our community.”

An earlier statement from the company said: “The crux of this dispute lies in regulatory issues between FDA and other federal laboratory regulators for COVID-19 testing, not the health, safety or substance of our testing. This has to do with regulatory approvals, not with test results.”

WTOP has reached out to both the FDA and the Centers for Medicare and Medicaid Services, which was said to be preparing a report on the matter.

Of the 265,000 COVID-19 tests given to Montgomery County residents, about 8% were provided by AdvaGenix, according to the county.

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