The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.

Within a month of disclosing a CA$175.6 million (US$124.7 million) award from the Canadian government to use its antibody discovery platform for the analysis of patients who have recovered from COVID-19, Abcellera Biologics Inc. closed a $105 million series B financing aimed at expanding its capacity and investing in new technologies that complement its antibody discovery engine.

The U.S. Department of Health and Human Services (HHS) has posted a national COVID-19 testing strategy in response to legislation passed in April, and the plan suggests that 300,000 tests per day should suffice to corral the pandemic. That calculation drew immediate fire from House and Senate Democrats, who characterized the plan as an attempt “to paint a rosy picture about testing,” but they also pushed the Senate to pass House legislation that would provide another $75 billion in funding for testing and contact tracing.

DUBLIN – Merck & Co. Inc. is placing two separate bets on recombinant viral vector technology in a broad effort to tackle COVID-19, in which it is also in-licensing a small-molecule antiviral drug. Kenilworth, N.J.-based Merck is acquiring Austrian vaccine developer Themis Bioscience GmbH in a move that propels the latter firm’s COVID-19 vaccine program to the front ranks of the industry pipeline. It is entering a COVID-19 vaccine development collaboration with the not-for-profit vaccine research organization IAVI.

The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”