Dive Brief:
- Thermo Fisher is the second commercial test developer to get FDA's nod for an emergency use novel coronavirus test available immediately, per an announcement late Friday. Roche was the first commercial test maker to achieve the status.
- On Sunday, the Trump administration's coronavirus task force also described details of a private-public partnership with commercial labs, and pledged to make 1.9 million high through-put tests available this week at 2,000 labs.
- Separately, the American Clinical Laboratory Association said late Friday it expects daily testing capacity to exceed 20,000 next week, with the potential to grow to 280,000 by April 1. Still, those estimates assume no shortages of necessary materials and supplies such as specimen collection swabs, N95 respirators, and materials for viral transport, ACLA added.
Dive Insight:
After what critics called a slow and patchy response and in particular botched testing roll-out, the administration in recent days has stepped up its efforts to coordinate the private sector and state and local officials to ramp up testing.
The government's top infectious disease official, longtime leader of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, said at the Sunday press conference: "We can describe this as entering into a new phase in the testing space."
Still Fauci warned that "the worst is ahead for us."
Like the emergency use authorization (EUA) given to Roche early Friday, FDA said it greenlighted Thermo Fisher's request within 24 hours of receipt. BD may be close behind; the company disclosed plans late Friday to file an EUA early next week for a test that can run on its molecular diagnostic system it says are already used in nearly every U.S. state.
In FDA's announcement of the Thermo Fisher EUA, Commissioner Stephen Hahn said "more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process," a jump from the 60 referenced earlier by Center for Devices and Radiological Health Director Jeff Shuren.
Thermo Fisher expects to be able to provide results within four hours of a lab's sample receipt. Its PCR instrument that runs the test is already used in clinical labs worldwide, the company said.
Thermo Fisher stood alongside BD, Quest, Roche and other major U.S. businesses involved in COVID-19 response at President Trump's declaration of a national emergency Friday.
At Friday's White House event, Quest CEO Steve Rusckowski said his company and LabCorp would be leveraging the SARS-CoV-2 diagnostic from Roche that was granted EUA.
"We now have capabilities from Roche Diagnostics that we will bring into our facilities this weekend," Rusckowski said. "And I know myself and also my colleague at LabCorp will be doing the same, so the capacity available to the American public to support this action with consumers will be considerably increased in the next few weeks."
BD said late Friday it will submit for emergency use authorization to FDA early this coming week. The test for the novel coronavirus will run on its BD MAX system, which the company said "is already in use in hundreds of laboratories across the U.S. in nearly every state." Another test maker, Spain-based CerTest Biotec, began running a SARS-CoV-2 diagnostic on BD's MAX systems in Europe last week.
BD also said it's working on a potential point-of-care test that would run on the same system as some of its flu and strep tests.
The list of other commercial players with recent COVID-19 updates includes Opko Health-owned BioReference Laboratories, which on Friday said it's now accepting specimens for testing from across the U.S. Alongside the New York State Department of Health, it's also providing testing via a public drive-through facility in New Rochelle, New York, and will aim to offer 5,000 tests per day at satellite testing locations in New York to be set up next week. Meanwhile, French biotech BioMerieux on Thursday said it's speeding three different SARS-CoV-2 tests to market.
Thermo Fisher at the start of the month announced a deal to acquire Qiagen for approximately $11.5 billion, a combination expected to be completed in the first half of 2021. The Department of Health and Human Services said Friday it awarded Qiagen $598,000 to support development of a rapid diagnostic to add to its existing respiratory panel. A test launch is not imminent; HHS said it could be ready within 12 weeks for FDA review.
HHS has also provided funding to DiaSorin, which it believes could have a test submission ready within 6 weeks, and Hologic, which is hoping to get a high-throughput test across the finish line sooner.
