ROCKVILLE, Md. — The CDC and the Maryland Department of Health have approved Rockville-based molecular diagnostic laboratory AdvaGenix to resume COVID-19 testing, the company said in a statement Wednesday.
According to company CEO and Chief Scientific Officer Dr. William Kearns, AdvaGenix has been found to be back in compliance with CLIA (Clinical Laboratory Improvement Amendments) regulations regarding coronavirus testing.
“AdvaGenix has confirmed the integrity of the specimens and accuracy of the tests we’ve conducted,” Kearns said. “We are in compliance with CLIA regulations and look forward to continuing our work to support the community and public health officials.”
The company had previously been contracted by Montgomery County to use AdvaGenix tests at six coronavirus testing sites. Kearns said AdvaGenix had invested a million dollars and hired a dozen techs to help the county deal with COVID-19.
According to Montgomery County, more than 19,000 AdvaGenix tests had been conducted over a two-month period – about 8% of all people tested in the county between June and August.
The county canceled that contract in August, however, when the Maryland Department of Health found AdvaGenix had not conducted a pre-analytical temperature stability study – something required by CLIA regulations. Kearns said at the time that the state of Maryland had not informed AdvaGenix the company had to check that box and that there were no issues with the tests or the testing protocols themselves.
Kearns said now that AdvaGenix is back in CLIA compliance, it plans to resume COVID-19 testing.
“Moving forward, AdvaGenix is focused on COVID-19 testing, molecular genetic testing and expanded offerings including influenza A and B testing,” he said.