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Key FDA Diagnostic Authorizations of the Week

Since the emergence of the SARS-CoV-2 pandemic in particular, news in the infectious disease drug and medical device pipeline has moved at an accelerated pace.

The following is a round-up of this week's key infectious disease FDA approval and authorization pipeline news, with links to full stories.

Quest: FDA Authorization Could Raise Daily Test Capacity by 35000

The newly authorized method extracts RNA with the Mag-Bind Viral RNA Xpress Kit and the Hamilton MagEx STAR.
  • The Mag-Bind test allows technicians to “isolate viral DNA & RNA from whole blood, serum, plasma & bodily fluids using magnetic beads” according to the manufacturer, Omega Bio-Tek. 
  • The MagEx STAR and related products are described by Hamilton Company as “fully automated solutions for magnetic bead-based nucleic acid extraction and is ideal for isolation of pathogen RNA from coronavirus...and can process up to 96 samples at a time.”
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First COVID-19 Diagnostic Test Approved for Everyone

The US FDA has given the go-ahead to allow an existing COVID-19 diagnostic test be indicated for everyone.

On Friday, the FDA reissued LabCorp’s COVID-19 RT-PCR Test for emergency use authorization (EUA) to indicate it for use to test people who do not have coronavirus 2019 (COVID-19) symptoms or who have no reason to suspect infection.

This makes it the very first COVID-19 diagnostic test with this indication.  

LabCorp was given the nod by the federal agency to expand use of its test to anyone, after the company provided data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population. 

“FDA’s authorization of the first diagnostic test to be used for anyone, regardless of whether they are showing symptoms of COVID-19 or have other exposure risk factors, is a step toward the type of broad screening that may help enable the reopening of schools and workplaces,” FDA Commissioner Stephen Hahn, MD, said.

Read more.
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