Coronavirus: South Bay Biotech’s Test Wins Emergency FDA Approval

SUNNYVALE, CA — A South Bay biotechnology firm announced Saturday that it has obtained emergency use authorization for a test that detects the new coronavirus in about 45 minutes.

Sunnyvale-based Cepheid received the emergency authorization from the U.S. Food and Drug Administration, Reuters reports.

The company’s Chief Medical and Technology Officer Dr. David Persing described the test in a statement as a “transformative” tool that can relieve some of the pressure healthcare facilities face.

"During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” Persing’s statement said.

“An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources."

The COVID-19 test is designed to work Cepheid’s more than 23,000 automated GeneXpert Systems globally, the report said.

Operating the testing systems doesn’t require special training.

The company said it will make the testing devices available by March 30 but offered no further details. The cost of the test is not yet known.

FDA Commissioner Stephen Hahn touted the device as an "important step" in expanding the United States' beleaguered testing capabilities.

“Today marks an important step in expanding the availability of testing and, importantly, rapid results,” Hahn said in a statement.

“Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

Read more at Reuters