The Rockville lab ordered by the state of Maryland to halt coronavirus testing after an inspection by federal and state experts over the summer has been given the all-clear to, once again, perform COVID-19 tests.
“I am pleased that AdvaGenix is approved to resume COVID-19 testing by the Centers for Medicare and Medicaid Services and the Maryland Department of Health,” said William Kearns, CEO and chief scientific officer of AdvaGenix, in a statement Wednesday. “AdvaGenix has confirmed the integrity of the specimens and accuracy of the tests we’ve conducted.”
AdvaGenix was Montgomery County’s main supplier of coronavirus testing before the Maryland Department of Health in August issued a cease-and-desist order that appeared to call into question all of the lab’s test results.
Montgomery County canceled its contract with the lab following the state’s order.
The lab had maintained test results were safe and accurate, and the issues uncovered by inspectors were a matter of “red tape” between the Food and Drug Administration, which authorized the lab to perform coronavirus testing, and another federal entity that regulates labs, known as CLIA.
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At issue was a dispute over whether the lab was required to perform a study of how lab specimens fared in high temperatures.
To resolve the inspectors’ concerns, the lab ended up conducting the temperature-stability study requested by inspectors, the results of which confirmed that specimens were not adversely affected by high heat common in the summertime, the lab previously said.
In the statement Wednesday, Kearns said, “We are in compliance with CLIA regulations and look forward to continuing our work to support the community and public health officials.”
Overall, AdvaGenix had performed a total of about 20,000 COVID-19 tests for Montgomery County before it was ordered to stop. Another 3,500 test samples that were collected from county residents were never analyzed as a result of the state’s cease-and-desist order.
After canceling its contract with the lab, Montgomery County moved on to another supplier: CIAN Diagnostic Laboratories in Frederick.
The county’s goal is to test 5% of the county’s 1.1 million residents each month. At a news briefing last week, County Executive Marc Elrich said the county was averaging about 11%.
Before jumping into the coronavirus testing field, AdvaGenix’s main line of business was genetic testing. “Moving forward, AdvaGenix is focused on COVID-19 testing, molecular genetic testing and expanded offerings, including influenza A and B testing,” Kearns said.