ROCKVILLE, MD — The Rockville lab ordered by the state to stop processing COVID-19 tests following an investigation into its protocols has been cleared to resume testing, the company announced Wednesday.
"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 AdvaGenix owner Dr. William Kearns. "AdvaGenix has confirmed the integrity of the specimens and accuracy of the tests we've conducted."
AdvaGenix, once the largest supplier of COVID-19 tests for Montgomery County, had to halt testing after state and federal officials visited the lab in August and found deficient practices.
Health officials did not go into specifics but said investigators found "improper laboratory and COVID-19 testing procedures that endanger patient health, safety, and welfare."
Montgomery County cut ties with the lab shortly thereafter.
Kearns disputed the investigation, saying that the tests were safe and accurate — and that the issues investigators found had to do with a "pre-analytical temperature stability study."
Before being ordered to stop, AdvaGenix had processed more than 19,000 tests — or roughly 8 percent of the total testing provided to county residents.
After cutting ties with AdvaGenix, the county inked a deal with CIAN Diagnostic Laboratories in Frederick.
Dr. Travis Gayles, the county's top health official, said the county recently had a conversation with AdvaGenix about its services.
"At this time, based upon our current needs, we have the (testing) capacity but, consistent with what we've always said, we continue to explore new partnerships, particularly if there are new opportunities for new technology to integrate into the systems that we have," he said. "So that's where we currently stand with AdvaGenix, as well as with other companies that could potentially be able to meet those needs as they arise in the future."
The county is consistently meeting its goal to test 5 percent of its population per month.