Hologic Gets FDA Authorization for Asymptomatic Covid Test - TheStreet

Hologic Gets FDA Authorization for Asymptomatic Covid Test

Hologic's coronavirus test for asymptomatic subjects has received emergency use authorization from the Food and Drug Administration.
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Hologic  (HOLX) - Get Report shares rose Monday after the medical instruments and supplies company said its coronavirus test had received emergency-use authorization from the Food and Drug Administration for asymptomatic subjects.

Shares of the Marlborough, Mass., company recently traded at $66.56, up 3.4%. The stock had climbed 23% year to date through Friday.

The company’s test is called Panther Fusion SARS-CoV-2. 

“Hologic’s assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people,” the company said in a statement.

“This availability is expected to play a key role in identifying early infection in exposed individuals, as well as reopening schools, workplaces and the economy in general.”

“[A]ccurately identifying individuals early in the course of infection -- so they can quarantine before passing on the virus -- is critical to stemming the spread of this pandemic,” said Kevin Thornal, president Hologic’s diagnostic solutions division.

An FDA report “compared more than 50 covid-19 tests and demonstrated that Hologic’s assays are the most analytically sensitive of the fully automated, high-throughput molecular tests on the market,” the company said.

“High analytical sensitivity is one of the key characteristics for tests to be used effectively in asymptomatic screening and pooling workflows.”

In other coronavirus news Monday, Inovio Pharmaceuticals  (INO) - Get Report said the FDA put its late-stage coronavirus-vaccine trial on “partial clinical hold.”

Novavax  (NVAX) - Get Report kicked off the final phase of its developing coronavirus vaccine trials in the U.K. 

And MediciNova  (MNOV) - Get Report said its intranasal coronavirus vaccine prototype was showing some success in tests on mice.