Update October 28: COVID-19 test provider AdvaGenix says it has once again been approved by the Maryland Department of Health to resume COVID-19 testing.

Montgomery County canceled its contract with the Rockville-based company about two months ago due to questions about testing procedures. In a statement, AdvaGenix CEO William Kearns said the company had confirmed “the integrity of the specimens and accuracy of the tests we’ve conducted.”

A spokesperson for Montgomery County said it has no plans to contract and partner with AdvaGenix, despite its renewed approval from MDH.

“Based on a review of our current and future needs, we have sufficient capacity with our current vendors.”

Update August 26: Two weeks after Montgomery County ended its contract for COVID-19 testing with AdvaGenix, the company says it has completed studies requested by a federal oversight agency that show its tests were not compromised by heat or oral contaminants.

A letter from AdvaGenix CEO and Chief Scientific Officer Dr. William Kearns says the company completed a stability study of specimens and found they were not affected by high temperatures. It also found the daily high temperatures did not exceed the “upper stability limit” that might affect samples on any day between June 1 and Aug. 16. 

“Based on AdvaGenix’s own study and based on review of local temperatures, we have determined that zero patient specimens were adversely affected by temperature,” Kearns wrote. 

The Rockville-based company also found common “oral contaminants” such as drinking coffee, soda, eating food, smoking or using Chapstick did not affect the expected result. However, Keans wrote they require patients to not eat, drink, smoke, or chew gum 30 minutes before the saliva test.  

The state will review the data and decide whether AdvaGenix can continue testing or not. 

Update August 19: In a letter to the Montgomery County Council, AdvaGenix says an updated state order clarifies that their license was not suspended and, therefore, the company should be able to continue working with the county to provide testing. The Maryland Department of Health did revise the order to remove the word “suspension” in regards to AdvaGenix’s lab permit. It now reads that AdvaGenix can’t take or process COVID-19 testing samples until the health department “authorizes” the company to do so. It’s not immediately clear how Montgomery County will proceed after announcing the cancellation of the contract with AdvaGenix yesterday.

Original:

Montgomery County is terminating its contract with Rockville-based COVID-19 test provider AdvaGenix after officials raised red flags about the company’s testing procedures.

The county had canceled its free COVID-19 testing program last week after a joint federal and state investigation found “improper laboratory and COVID-19 testing procedures that endanger patient health, safety and welfare.”

An inspection revealed that the irregularities may have jeopardized the results of more than 17,000 tests, according to a spokesperson for Maryland’s Department of Health. AdvaGenix had administered 8% of the tests taken in Montgomery County, totaling about 19,000 tests over the last two months, according to the county.

Montgomery County health officials are advising anyone who has received a saliva-based test at a county government site in the last two weeks to seek another test elsewhere.

In a statement, AdvaGenix CEO and Chief Scientific Officer William Kearns defended the reliability of his company’s tests, attributing the investigation’s findings to regulatory red tape.

“It’s unfortunate that the county has taken this action when we expect a swift resolution to the regulatory issues in question,” Kearns said.

In an interview with ABC 7, the CEO called a cease-and-desist order from the state a “hit job.”

All county-operated testing sites remain closed until further notice. The county is working to fill the gap with tests supplied by the state. The Maryland Department of Health plans to replace the jurisdiction’s weekly supply of tests for the next four weeks, and officials are “working to identify additional test sources to support the County Government’s effort to offer broadly available free tests,” says a county press release.

Montgomery County is still testing symptomatic residents, and those tests are being processed by other labs, officials say. Individuals with symptoms can schedule a COVID-19 test by calling the county’s testing helpline at 240-777-1755.

Kavitha Cardoza contributed reporting.