Lab Defends Itself After State Raises COVID-19 Testing Concerns

ROCKVILLE, MD — Rockville-based AdvaGenix labs — the largest supplier of COVID-19 tests at sites run by Montgomery County — is disputing an investigation that found deficient practices that could "endanger patient health, safety, and welfare."

Speaking outside AdvaGenix's laboratory on Friday, owner Dr. Williams Kearns told multiple media outlets that the company is "being slandered."

"We are being slandered, and I'll leave it at that," Kearns said. "I think there's a lot more going on here than meets the eye."

Kearns told reporters that state and federal officials investigated AdvaGenix last week, after receiving an anonymous complaint.

What investigators found was "improper laboratory and COVID-19 testing procedures that endanger patient health, safety, and welfare," according to the Maryland Department of Health.

The department did not go into specifics, but ordered AdvaGenix to immediately stop providing tests until the deficiencies were corrected.

In May, Montgomery County officials inked a deal with AdvaGenix to provide coronavirus testing to about 20,000 people per week. The self-administered oral swab tests could produce results in fewer than 48 hours.

Following the release of the findings, Montgomery County officials temporarily shut down most of its COVID-19 testing sites. They did not say exactly when the clinics would reopen, but urged the thousands of residents who got tested in the last two weeks to get retested.

One Takoma Park resident said her daughter had already gotten retested after receiving a false positive from AdvaGenix.

"We had anyone who had been around her tested. She was tested again several times after that and the results were always negative," Lisa Goodwin told Patch. "It disrupted our lives. We were unable to work. It caused undue stress to her, on our family, and extended family."

Speaking to reporters on Friday, Kearns said AdvaGenix's test results were safe and reliable — and that investigators had an issue with a "pre-analytical temperature stability study."

The study, he explained, is required by the Centers for Medicare & Medicaid Services, not by the U.S. Food and Drug Administration.