COVID-19 update: U.S. test capacity to reach 10,000/day; pharma White House meeting Monday; Scangos heading BIO response
The first death in the U.S. attributed to COVID-19 was disclosed on Feb. 29. Within hours the federal government and the biopharmaceutical industry announced new responses to the outbreak.
FDA released a policy that will quickly expand COVID-19 testing, President Donald Trump told reporters about a White House meeting with pharmaceutical industry leaders, and BIO made public an initiative to bring the biotech industry into the fight.
The FDA policy allows high complexity, CLIA-certified laboratories to immediately begin testing for COVID-19 while they are pursuing an Emergency Use Authorization (EUA). Previously the agency had required that labs wait until they had completed the EUA process.
The guidance permits labs to start offering coronavirus testing as soon as validation is complete. It recommends that labs submit an EUA request 15 business days after validation.
Prior to the guidance released Saturday, COVID-19 testing in the U.S. was restricted to public health labs using kits provided by the CDC. A flaw in kits released by CDC had limited the number of tests that could be performed.
The combination of the new FDA policy and expanded availability of CDC test kits will bring U.S. COVID-19 test capacity to 10,000 tests per day by the end of next week, Scott Becker, CEO of the Association of Public Health Laboratories, said in a tweet.
Also on Feb. 29, Trump said that leaders of the largest pharmaceutical companies will meet at the White House on March 2 to discuss the development of COVID-19 therapies and vaccines.
The meeting had been scheduled prior to the outbreak to discuss drug pricing. Trump said drug pricing will remain on the agenda along with medical countermeasures.
BIO announced that George Scangos, CEO of Vir Biotechnology Inc. (NASDAQ:VIR), is chairing the trade association’s committee on coronavirus response efforts.
Vir is partnering with WuXi Biologics Inc. (HKEX:2269) to discover and develop mAbs against COVID-2 (see “Vir, WuXi Collaborating on COVID-19 mAbs”).
The BIO committee is coordinating a biotechnology industry-wide effort involving dozens of companies that "have stepped forward with diagnostics, vaccines and potential new therapeutics," BIO Chairman Jeremy Levin told BioCentury. Levin is chairman and CEO of Ovid Therapeutics Inc. (NASDAQ:OVID).
BIO is “working closely with our members to help them connect with the appropriate government agencies and organizations,” Rich Masters, BIO’s EVP for public affairs, told BioCentury. “This is particularly important for small companies that may not have the resources or experience in working with these entities. In these cases, BIO is leveraging our relationships to ensure that the best science is connecting with the right partners.”