ROCKVILLE, Md. — Montgomery County has ended its contract with AdvaGenix, the Rockville-based company that was providing and processing COVID-19 tests for the county government's free testing clinics, officials announced Tuesday.
The Maryland Department of Health issued a cease-and-desist directive and order last Friday prohibiting AdvaGenix from processing COVID-19 tests.
"In response to the State’s announcement last week, the County has been working to restore its testing capacity and reopen testing sites. The Maryland Department of Health has committed to replace the weekly supply of tests for the next four weeks," Montgomery County officials said in a release.
According to Dr. William Kearns, CEO and chief scientific officer for AdvaGenix, the “crux of the dispute” relates to federal laboratory regulations for COVID-19 testing – not the “health, safety or substance of our testing.”
Kearns told WUSA9 on Monday, the same day the lab was inspected, that the single deficiency found was a "pre-analytical temperature stability study" that is required by CLIA – a set of guidance issued by the Centers for Medicare & Medicaid Services for labs performing COVID-19 tests – but not the FDA.
"It's unfortunate that the county has taken this action when we expect a swift resolution to the regulatory issues in question,” Kearns said. “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."
County officials are working to identify additional test sources to support the effort to offer broadly available free tests.
The county will continue to provide testing to symptomatic individuals using existing partnerships with other labs, officials said. According to the county’s statement last week, AdvaGenix tests had primarily been used on asymptomatic subjects.
On Aug. 13, Montgomery County Executive Marc Elrich and County Health Office Dr. Travis Gayles said the county’s COVID-19 testing program that was being processed through AdvaGenix had been “suspended immediately following a thorough review of the AdvaGenix testing and lab process.”
Since the beginning of the COVID-19 pandemic, more than 265,000 COVID-19 tests have been administered to county residents. Tests provided by AdvaGenix were approximately 8% of these tests.
The AdvaGenix kits were primarily used at the Wheaton Library and Community Recreation Center testing sites. County officials have asked residents tested at either site over the past two weeks to get retested at another location.
Elrich also said during a press conference Thursday morning that the county was looking for backup kits to resume testing at the affected sites.
The county signed a contract with AdvaGenix in May to use the company’s self-administered oral swab coronavirus tests. The tests promised results in 48 hours or less.
At the time, Elrich called the contract a “game-changer” for the county.
The county’s statement did not specify what specific issues had been identified with AdvaGenix’s lab or testing processes. WUSA9 reached out to the Maryland Department of Health for more information.