The U.S. FDA has nudged the emergency use authorization (EUA) program forward once again, this time with a template for applications for tests that can be performed entirely at home, in the office and at schools. FDA Commissioner Stephen Hahn said in an accompanying statement that tests of this sort “will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”
The agency said the template updates the benchmarks for both sensitivity and specificity, adding that the sensitivity metric for non-lab testing is lower than is recommended for lab-based tests. It also said that while this does incur some risk, it is more than offset by the “tremendous benefits of broader access to simple and fast testing options.”
The template addresses molecular and antigen diagnostic testing using specimens drawn from respiratory samples and saliva. Of note, human usability studies should include at least 100 participants for OTC tests, while only 30 participants would be needed for prescription-only tests. Sponsors should evaluate the test at a minimum of two testing sites – thereby encouraging diverse enrollments – or recruit for an at-home study via the internet. The template said that an at-home study may have to include collection of comparator samples via an FDA-authorized home collection kit and a molecular assay authorized for that collection kit.
The template also advised that the use of monetary incentives can bias the enrollment population, so the sponsor should contact that agency prior to the onset of recruitment. An observer may be necessary if the sample is drawn by the parent when the subject is aged between 3 to 13 years, while those aged 14 to 17 years can self-collect, again with an observer present. The enrollment should include all ages, with 20% coming from those younger than 14 and roughly 35% aged at least 65.
Quest: FDA has approved new extraction method
In other COVID-19-related news, Quest Diagnostics Inc., of Secaucus, N.J., said the FDA has granted the company an EUA for a novel lab technique that will cut down on the time needed to extract viral RNA from patient specimens. Quest said the authorization will enable the company to expand its daily testing capacity by 35,000 tests per day.
Steve Rusckowski, Quest’s board chairman and CEO, said this new technique would be deployed to a number of the company’s labs across the U.S., adding, “with more testing capacity, we expect to improve turnaround times for our customers and patients.” Five of Quest’s labs can run the new extraction method, which can be applied to pooled specimens. The labs in question are located in two sites in California (San Juan Capistrano and Valencia), and one location each in Texas, Kansas, Virginia and Massachusetts.
Quest said it can perform 135,000 COVID-19 molecular diagnostic tests per day, and that the new technique will provide an additional 35,000 tests a day “in overall capacity over the next several weeks.” The combination of specimen pooling and the new method will “increase capacity even further,” Quest said, projecting a total capacity of 180,000 tests per day by Labor Day. In the coming weeks, the company said it will be able to process priority one patient samples in a single day, while other tests will be handed within two to three days.
Advamed’s Whitaker: Time for a testing supply registry
The effort to push back against the SARS-CoV-2 virus has been hampered by inadequate supplies of several items. However, the task of tracking these supplies has been complicated by the vastness of the U.S. and the large number of different lab types. Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), made the case in a July 29 op-ed that the time has come for a national registry for tracking these supplies.
Whitaker posed the question of whether the latest surge in diagnoses is a second wave of the COVID-19 pandemic rather than an echo of the first wave, adding that there is little dispute that the solution requires the ability to “test everyone who needs it.” Just as central to that effort is the ability of manufacturers to send their supplies to the locations most in need, thus the justification of forming a testing supply registry.
Whitaker said this registry has the support of Advamed and 13 diagnostic testing companies, which represent 95% of the national testing capacity. The registry takes in data from the 13 participants along with publicly available data on the number of tests performed, permitting the creation of a routinely updated picture of tests shipped in the U.S. each week. This database covers molecular, serology and antigen tests.
Since the onset of the pandemic, roughly 80 million tests have been shipped, with daily shipments now numbering more than 1 million per day. Whitaker said a group of scientists from Harvard University had argued that 1,500 tests per 1 million U.S. residents would have to be conducted daily to get a handle on the pandemic, adding that 2,000 tests are being conducted per million as of this week. Whitaker said that if the road to recovery “goes through testing,” the COVID-19 test supply registry “provides the map.”