Montgomery County terminates coronavirus testing contract with AdvaGenix

County terminates COVID-19 testing contract with AdvaGenix

State ordered Rockville lab to stop testing after concerns about protocols

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Montgomery County has terminated its COVID-19 testing contract with Rockville lab AdvaGenix after state officials ordered the company to stop testing because of concerns about protocols.

The lab was processing COVID-19 tests in the county for asymptomatic individuals, providing 88% of the total testing offered through county-operated sites. AdvaGenix accounted for 8% of total testing provided by the county, state, medical providers, and others.

The contract termination follows the state’s Aug. 14 cease and desist order and directive for AdvaGenix to stop processing the tests, which were self-collected.

The state halted the testing because of “improper laboratory and COVID-19 testing procedures that endanger patient health, safety and welfare,” according to the order.

But in a statement sent to Bethesda Beat Monday evening, Dr. William Kearns, CEO and chief scientific officer of AdvaGenix, said the company’s coronavirus tests are “safe and effective.”

“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,” he said. “This has to do with regulatory approvals, not with test results. We believe we have followed the FDA approval process, Maryland state guidance, all of the recommendations of the test’s manufacturer, and we have worked cooperatively with public health officials.”

In a statement released later on Tuesday afternoon, Kearns said the company is still working to resolve the dispute and get back to testing.

“It’s unfortunate that the county has taken this action when we expect a swift resolution to the regulatory issues in question,” he said.

The state estimated that as many as 17,254 people might have been affected. Mary Anderson, a spokeswoman for the county’s health department, told Bethesda Beat Friday afternoon that approximately 18,000 residents have been given an AdvaGenix test in the county.

On Aug. 13, the county announced that it was temporarily suspending tests at county-operated clinics following the state discussing its joint investigation with federal officials.

In a press release sent Tuesday afternoon, county officials stated that they are working to restore testing capacity and reopen testing sites. All of the county’s testing sites except one — Wheaton Library and Community Recreation Center — were closed down starting Thursday. Appointments at the centers were canceled.

State-provided testing of 5,000 tests per week will be used at the Wheaton recreation center. The test will be provided for the next four weeks through CIAN Diagnostics laboratories.

Charlie Gischlar, a spokesman for the state health department, told Bethesda Beat Friday afternoon that the state’s order stops AdvaGenix’s COVID-19 testing until it has corrected “deficient practices.”

Symptomatic individuals are still being tested through other labs that have “existing partnerships” with the county, according to the release.

Kearns said in the AdvaGenix statement that the lab has been a “loyal and reliable” partner to the county and provided tests and results in a “timely manner.”

“We have done all that has been asked of us. … We look forward to resolving this with our regulators as quickly as possible, to get back to the important work of testing.”

Although Kearns said the dispute isn’t related to test results, Dr. Travis Gayles, the county’s health officer, said in a media briefing on Thursday that anyone who has been tested with an AdvaGenix test in the last two weeks should consider being retested.

More than 265,000 residents have been tested in the county since early March.

Need a test?

Residents with COVID-19 symptoms are asked to call the Testing Helpline at 240-777-1755 to schedule a test.

There are more than 30 testing sites operated by the county, state, medical providers and others in the county.

Briana Adhikusuma can be reached at briana.adhikusuma@bethesdamagazine.com.

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