Montgomery Co. to reopen testing sites but questions over AdvaGenix tests remain

Montgomery County, Maryland, is restarting coronavirus testing at some county-run testing sites beginning Thursday, nearly a week after testing was temporarily suspended when the county’s provider of COVID-19 tests was ordered by the state to halt operations.

Walk-in testing resumes at the Plum Gar Recreation Center in Germantown on Thursday, and at the White Oak Recreation Center on Friday, County Executive Marc Elrich told reporters during an online news briefing Wednesday.

The test sites will use alternative coronavirus tests provided by the state.

The announcement comes just a day after the county terminated its contract with Rockville-based genetic lab AdvaGenix.

An inspection by federal and state health officials last week turned up “deficient practices” that called into question thousands of tests, according to the Maryland Department of Health, which had issued a cease-and-desist order barring the lab from processing COVID-19 tests.


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Lab blames ‘red tape’

The state has not yet explained the exact issue flagged by inspectors.

The lab has maintained its tests are safe and reliable, and the issue is 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.

There is an apparent dispute about whether the lab was required to perform a separate in-house “temperature-stability” study of the saliva-swab test kits it processes, or whether it could rely on temperature studies carried out by the manufacturers of the test kits themselves — in this case, Rutgers’ Clinical Genomics Laboratory and Utah-based Spectrum Solutions.

In a letter Wednesday to the Montgomery County Council, Dr. William Kearns, the AdvaGenix CEO and chief scientific officer, wrote that federal inspectors made an unannounced visit to the Rockville lab on Aug. 10 and “talked with us about additional specimen validation studies that they felt were necessary.”

In the letter, Kearns said the company is now conducting its own temperature study, which should be completed by the end of the week and “should resolve stated concerns by the state.”

In addition, the lab said the initial cease-and-desist order sent by the state inaccurately stated AdvaGenix’s laboratory license had been suspended.

“That is not correct,” Kearns said in the letter. “Our license has not been suspended and there is no basis to do so.”

A revised order by Maryland Health Secretary Robert Neall issued Tuesday removes the line about the suspension and said instead that the lab is barred from performing COVID-19 tests until the state “authorizes” it to resume testing.

In the letter to the county council, Kearns wrote: “We should be fighting the virus, not red tape. We want to serve our neighbors during this time of need. As a small business operating in Montgomery County, we would like to do all we can to keep the residents of Montgomery County safe and healthy.”

During the news briefing, officials said they had not yet seen Kearns’ letter to the county council.

Responding to questions from reporters Wednesday about why the county ended its contract with AdvaGenix, county officials pointed to the state’s original order barring AdvaGenix from performing the COVID-19 tests.

Sylvia Kinch, with the Montgomery County Office of the County Attorney, said: “Simply put, at this point in time, AdvaGenix is not able to comply with the terms of the contract because it’s not able to provide the testing that we had agreed to.”

‘We have no idea right now what the reasons were’

More than a week after the county first learned of the lab inspection, Elrich and Montgomery County Health Officer Dr. Travis Gayles said they still aren’t sure why the state ordered AdvaGenix to cease its testing operations.

“We have no idea right now what the reasons were,” Elrich said. “We have yet to see a report, at least that’s the last I heard, because we had not received anything on the case and why the state took the action that it did other than that it took the action.”

Gayles added, “I can’t tell you definitively there was an issue with A, B and C that caused the concern. We’re merely going off of what has been shared with us, in terms of knowing that there was an investigation and the order that was put into place by the secretary of health.”

The inspection was carried out by inspectors with the state and the federal Centers for Medicare and Medicaid Services. “We were not involved in that process,” Gayles said.

The county attorney said Montgomery County has not yet received an invoice for any of the nearly 18,000 tests AdvaGenix performed over the past two months.

Elrich said it’s “totally possible” the county could renew its contract with AdvaGenix “assuming everything gets cured.”

WTOP has reached out to the state health department about why the state’s original cease-and-desist order was revised, as well as the Centers for Medicare and Medicaid Services for a copy of the inspection report or a summary of its findings.

Fewer cases, but fewer tests statewide

Meanwhile, Montgomery County recorded 59 new coronavirus cases Wednesday out of a total of 2,330 tests performed in the county, which is the highest number of tests performed in the state, according to Elrich.

Statewide, there were 414 new coronavirus cases reported, and a total of about 13,800 tests. The number of tests is down by more than half from the day before.

“What we’ve seen across the county over the last several days is cases have decreased,” Gayles said. “But there is a concerning trend that testing is down significantly across the board.”

“We’re going to continue to watch and monitor to see if that is an ongoing trend, if we are seeing continued decreases in the amount of testing that’s provided … because certainly we want to see testing numbers higher as the case counts come down,” Gayles said.

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