Almost a week after Maryland ordered a Rockville-based laboratory to shut down its COVID-19 testing program, then seemingly eased that restriction Tuesday, questions remain over whether AdvaGenix tests are safe and reliable.
The company was Montgomery County’s largest coronavirus testing supplier before county leaders terminated their contract with the firm Tuesday in the wake of a cease-and-desist letter the Maryland Department of Health sent the firm last week.
On Wednesday, AdvaGenix CEO William Kearns called the state’s action an “error” in a letter to county leaders.
“While I am relieved to have the error corrected in the form of a revised order, the mistake did not come without consequences to the County and our residents. This error caused great disruption to the County’s testing program,” Dr. Kearns said in a letter to Montgomery County council members. “The error also caused confusion to the public, calling into question test results for more than 17,000 residents.”
Still, it’s not clear whether state or local officials are back on board with the firm.
A day earlier, the state health department revised its original cease-and-desist order, lifting the suspension of the company’s laboratory permit, but warning that the company can only collect and process COVID-19 samples when the Office of Health Care Quality gives it the green light to resume.
Still, the county ended its contract with AdvaGenix on Tuesday after suspending tests last week at government-operated clinics that were meant to primarily serve asymptomatic individuals due to concerns over the company’s testing and lab procedures.
Dr. Kearns, in his letter to county leaders, said the state inaccurately stated in the original order that the firm’s license had been suspended.
“That is not correct,” he wrote. “Our license has not been suspended and there is no basis to do so.”
He blamed “red tape” for the health department’s action.
“We should be fighting the virus, not red tape,” he wrote. “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.”
The Maryland health department said the updated order clarifies the fact that AdvaGenix has to cease only its COVID-19 testing and that it continues to “await notification from the lab that it has corrected its deficient practices.”
The state’s amended order says preliminary findings from a joint federal and state investigation of AdvaGenix found that there were “certain improper laboratory and COVID-19 testing procedures that endanger patient health, safety and welfare.”
On Wednesday, Montgomery County officials said they were unsure exactly as to why the state suspended the use of these tests.
“The reason we cannot comment on what issues may be brought up with the tests is that we don’t have a copy of the report. We don’t have definitive findings. … I can’t tell you definitely there were issues 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 there was an investigation and the order was put into place by the Secretary of Health,” said County Health Officer Travis Gayles.
A couple of walk-in testing clinics in Montgomery County are reopening this week. Testing at the Plum Gar Recreation Center at 19561 Scenery Drive, Germantown will be open Thursday from 1 to 4 p.m. The White Oak Recreation Center at 1700 April Lane, Silver Spring will be open for testing Friday from 9 a.m. to 4 p.m. Both of these sites had administered the AdvaGenix tests.
The county partnered with AdvaGenix in May to primarily test asymptomatic individuals such as frontline workers and nursing home staff and residents with oral swab tests. The county is still providing testing to symptomatic people at other labs.
Montgomery County ranks second after Prince George’s County with the most coronavirus cases in Maryland with more than 19,100 infections and 770 deaths reported as of Wednesday, according to health department data. Prince George’s County has reported more than 25,000 cases and 760 deaths. For the entire state of Maryland, the coronavirus has sickened more than 101,600 and killed more than 3,500 people.
For the next month, the state will provide 5,000 kits each week while the county searches for other test suppliers, according to a statement released last week.
In his letter to council members, Dr. Kearns said an unscheduled clinical lab inspection occurred at AdvaGenix on Aug, 10. The inspectors had reportedly determined that “additional specimen validation studies” were needed, which Dr. Kearns says the company will complete shortly. He also said the company is conducting its own in-house temperature stability study, which should resolve concerns outlined by the state.
AdvaGenix tests make up about 8% of the more than 265,000 total coronavirus tests administered to residents since the pandemic began.
Dr. Gayles recommends that residents who have been tested in the past two weeks at government-funded clinics using the AdvaGenix tests get retested at another site.
County residents with COVID-19 symptoms can call the Testing Helpline at 240-777-1755 to schedule a test. Residents can visit Maryland’s testing locator web page to find additional testing clinics.
• Shen Wu Tan can be reached at stan@washingtontimes.com.
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