FDA Fast Tracks San Diego Company's Multi-Virus Rapid Test, In Time for Flu Season

Carlsbad-based GenMark Diagnostics has been given emergency use authorization for its ePlex Respiratory Pathogen Panel 2 (RP2), a rapid result diagnostic test that screens for multiple viruses at once, including the virus that causes COVID-19.

NBC Universal, Inc.

As we enter flu season, a San Diego-based company has received emergency FDA clearance for a test that can screen for the flu, coronavirus and other viruses on one patient sample.

It’s meant to keep hospitals from being overwhelmed as the ongoing COVID-19 pandemic overlaps with flu season. The two diseases present many of the same symptoms.

Carlsbad-based GenMark Diagnostics has been given Emergency Use authorization for it’s ePlex® Respiratory Pathogen Panel 2 (RP2), a rapid result multiplex molecular diagnostic test.

CEO Scott Mendel told NBC 7 the test can screen a critically ill patient for multiple viruses including the coronavirus and results take less than two hours.

It can help health care providers on the front lines, too.

“One of their nurses presented a fever and they were unsure what she had,” said Mendel, recounting an example of how the test helped a hospital make better-informed decisions. “Only did they know that she didn’t have COVID-19, they had even more confidence because they were able to identify what she did have, which was just the common cold.”

Hospitals like Rady Children’s and Scripps have been using a simpler version of the test for years, but will now pivot to the expanded version.

Mendel told NBC 7 the test has been on the market for small scale use since July. The FDA approval allows for companies to shorten the typical 6 to 12-month process to get it commercialized and distributed to more places around the country.

The test will only be available to hospitals and health care providers for use on patients.

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