The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.

In Monday's report: FDA facilitates diagnostic test availability for asymptomatic testing and sample pooling, U.S. Republicans' reactions to new outbreaks, and other Congressional updates.

Monday, 29 June 2020

• On 16 June, the U.S. Food and Drug Administration (FDA) posted updates to their Molecular Diagnostic Templates for developers that intend their assay to be used for pooled patient samples or for screening asymptomatic individuals not suspected of having COVID-19. FDA has previously authorized molecular diagnostic tests for individuals suspected of having COVID-19 by their health care provider, where patients may be symptomatic, pre-symptomatic, or asymptomatic. Importantly, it has always been at the discretion of health care providers whether or not to test asymptomatic individuals. There is currently no SARS-CoV-2 diagnostic test for the broad screening of asymptomatic individuals for COVID-19. Recognizing that organizations may want to conduct screening of asymptomatic individuals as part of a broader strategy to help ensure the safety of their employees, patients, students and others, FDA has updated their Emergency Use Authorization (EUA) templates and available FAQs to assist developers who wish to develop tests for screening asymptomatic individuals. Given that testing asymptomatic individuals means an increased number of tests and an expected lower level of disease prevalence, particularly if the population is at low risk for exposure to or contracting COVID-19, developers may be interested in using pooling techniques to preserve testing resources. Read more here.

• The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. Congressional leaders will soon name the chair of the coronavirus oversight commission, which was created by the CARES Act to increase transparency and oversight of the coronavirus relief funds. A new Government Accountability Office (GAO) report said the $670 billion Paycheck Protection Program had limited safeguards and insufficient guidance and oversight planning all of which have increased the likelihood that borrowers may misuse or improperly receive loans. The latest coronavirus outbreaks are reshaping the GOP’s political and legislative strategy, with Republicans planning to focus more on health care in the next coronavirus relief bill. They’ve also expressed rare frustration at the Trump administration for its decision to wind down federally supported testing sites. Read about these and other updates online here.

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