U.S. moves to unlock COVID-19 test capacity
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The U.S. government and industry took steps Friday to unlock COVID-19 testing capacity, including authorizing a commercial test, allowing New York to regulate tests conducted in the state, and funding development of two rapid diagnostics.
HHS Secretary Alex Azar appointed Brett Giroir, assistant secretary for health and head of the Public Health Service, to coordinate COVID-19 diagnostic testing efforts across the U.S. government and the private sector.
CDC Director Robert Redfield and FDA Commissioner Stephen Hahn will report to Giroir on all issues related to COVID-19 diagnostic testing.
The most immediate results will come from the Emergency Use Authorization (EUA) FDA granted to Roche for COVID-19 tests that run on the company’s automated cobas 6800 and cobas 8800 systems.
FDA had allowed Roche (SIX:ROG; OTCQX:RHHBY) to ship test materials ahead of the authorization, so large-scale testing should start quickly.
The cobas test systems, which are widely used around the world, are the first commercial tests to receive an FDA EUA.
Each cobas test unit can provide “up to 96 results in about three hours and a total of 1,440 results for the cobas 6800 System and 4,128 results for the cobas 8800 System in 24 hours,” Roche said.
The company said it will make “millions of tests a month” available.
The test is also “available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present,” Roche said.
FDA said it exercised its “enforcement discretion and is not objecting to the New York State Department of Health (NYSDOH) authorizing certain laboratories in New York to begin patient testing” for COVID-19.
BARDA funding Qiagen, DiaSorin tests
HHS’s Biomedical Advanced Research and Development Authority is funding development efforts at Qiagen N.V. (Xetra:QIA; NYSE:QGEN) and DiaSorin Molecular LLC to develop systems that could provide COVID-19 test results in one hour.
DiaSorin's test will be used on the company’s Simplexa Direct technology, a platform FDA has cleared for influenza and respiratory syncytial virus (RSV) tests.
DiaSorin could submit its rapid COVID-19 test for EUA within six weeks, BARDA said, while Qiagen’s test “could be ready within 12 weeks for EUA consideration by the FDA.”
Thermo Fisher Scientific Inc. (NYSE:TMO) is acquiring Qiagen in a deal announced March 3 (see “Thermo Takes Out Qiagen for $11.5B”).
Other tests are also reaching the market.
Luminex Corp. (NASDAQ:LMNX) said Friday that four independent clinical labs have validated laboratory developed tests (LDTs) for automated, rapid detection of the SARS-CoV-2 virus using the company’s Aries System.
“These LDTs demonstrate that high complexity laboratories using the Aries System can immediately add novel coronavirus diagnostics to their testing menu,” the company said.
Separately, CerTest Biotec S.L. said Friday it is rolling out a COVID-19 test in partnership with Becton Dickinson. The real-time PCR test, which can provide results for up to 24 samples in less than three hours, will be available only in Europe, the partners said.