After declaring a national emergency to allow more federal aid to states scrambling to address the COVID-19 pandemic, President Donald Trump’s administration has vowed to step up the quantity and availability of novel coronavirus diagnostics through efforts led by diagnostics developers and supported by Google and retail giants.
The commitment announced Friday afternoon in a nationally-televised press conference, was intended to resolve weeks of controversy fueled by the botched rollout of the CDC’s initial test for SARS-CoV-2, the slow pace of testing in part due to government red tape, and political squabbling.
Two grants totaling about $1.3 million were announced Friday by the U.S. Department of Health and Human Services (HHS). The Biomedical Advanced Research and Development Authority (BARDA) will award $679,000 to DiaSorin Molecular of Cypress, CA, toward rapid development of its Simplexa COVID-19 Direct Assay, while QIAGEN will receive approximately $598,000 to accelerate development of its QIAstat-Dx RPS2 test for COVID-19.
Additionally, HHS Secretary Alex Azar II, MD, designated Admiral Brett Giroir, MD, Assistant Secretary for Health and head of the Public Health Service, to coordinate COVID-19 diagnostic testing efforts among Public Health Service agencies—including the Centers for Disease Control and Prevention, the FDA, as well as state and local public health authorities, and private and public clinical laboratories.
A day earlier, the FDA approved its third Emergency Use Authorization (EUA) for a diagnostic since the outbreak of COVID-19—but the agency’s first for a commercially-distributed test—by approving Roche’s cobas SARS-CoV-2 Test within 24 hours of receiving the company’s application.
To speed up access to the test, the FDA offered no objection to Roche pre-positioning its test so that labs could initiate testing immediately upon authorization of the EUA. As a result, laboratories can immediately run tests on Roche’s high-volume platform, which will greatly increase national testing capacity, the FDA said.
During the event, Trump announced that the federal government and Google are partnering to develop a website allowing users to screen themselves for novel coronavirus by answering questions about their symptoms and their risk factors, to see if they warrant getting tested. The website would direct users to a “drive through” testing site, White House Coronavirus Response Coordinator Deborah L. Brix, MD, told attendees.
Google is among corporate giants that are partnering with the Trump administration to widen access to testing, along with retail rivals Walmart and Target, and healthcare/pharmacy chains CVS Health and Walgreens.
Investors signaled support for the national emergency declaration and accelerated testing efforts by propelling the Dow Jones Industrial Average to its biggest single-day point gain ever, rocketing 1,985 points or 9.3% a day after it posted the worst one-day loss since Black Friday 1987.