As of Tuesday, FDA has authorized 203 tests related to SARS-CoV-2, the virus that causes COVID-19. These include 166 molecular diagnostic tests, 35 antibody tests, and two antigen tests. But widespread access to the tests themselves is only half the battle. Communities impacted by the virus also need access to COVID-19 testing supplies like, like nasopharyngeal swabs and viral transport media.
The Advanced Medical Technology Association (AdvaMed) recently unveiled a national testing registry that compiles information from diagnostics companies along with publicly available data on daily tests performed to create a centralized and standardized COVID-19 testing supply registry.
The registry is expected to provide weekly state- and national-level updates on the number of molecular, antigen, and serology (antibody) tests shipped in the United States to help state and federal governments in their pandemic responses. AdvaMed and AdvaMedDx, the association’s division of diagnostics companies, developed the registry in partnership with 13 commercial diagnostics manufacturers: Abbott, BD, bioMérieux, Bio-Rad, Beckman Coulter, Cepheid, Hologic, Ortho Clinical Diagnostics, QIAGEN, Roche Diagnostics, Sekisui Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific. According to AdvaMed, these companies represent 95% of the COVID-19 testing market.
Scott Whitaker, president and CEO of AdvaMed, penned an op-ed piece published by Morning Consult, describing the important role that the registry will play in the fight against COVID-19.
"If the road to recovery goes through testing, we believe this registry provides the map," Whitaker wrote. "We stand ready to partner with all healthcare providers, laboratories, and other key stakeholders in the testing ecosystem to collaborate in any and every way we possibly can to win this fight."
Whitaker said the registry will create a deeper understanding of the supply of COVID-19 tests, with the aim of bolstering coordination across a wide set of public and private sector entities working to increase testing availability. It is a key step in identifying, addressing, and unlocking any challenges to the continued growth in U.S. COVID-19 testing, he said.
According to the most recent dataset AdvaMed has published from the new COVID-19 testing registry, total U.S. shipments of COVID-19 molecular diagnostic tests reached about 100 million, as of July 25.
“The 100-million mark represents yet another extraordinary milestone as the medical technology industry ramps up to meet the demand for testing posed by the coronavirus pandemic,” Whitaker said in an AdvaMed press release. “The diagnostics industry will continue to work 24/7, around the clock, to ensure widespread availability of test kits and supplies, doing everything possible to help beat this public health crisis.”
Balancing the urgency of COVID-19 testing with regulatory oversight
FDA has had its work cut out for it this year. Along with issuing an unprecedented number of emergency use authorizations for COVID-19 tests, ventilators, and other medical devices aimed at addressing pandemic-related needs, the agency has a responsibility to make sure it is still providing adequate oversight on these new products.
In June, FDA began cracking down on previously authorized tests that later turned out to have accuracy concerns. Chembio Diagnostic System's SARS-CoV-2 antibody test, which had been among the first COVID-19 antibody tests authorized in the United States, was also among the first to have its emergency use authorization revoked.
FDA said it has learned more regarding the capability for performance of SARS-CoV-2 antibody tests during the pandemic, and what performance is necessary for users to make well-informed decisions, and Chembio's test didn't make the cut.
“Since the beginning of the COVID-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed,” Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health, said at the time. “By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate – including taking action when a test’s benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public.”