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FDA approves San Diego company's coronavirus test kit

Posted at 4:54 PM, Mar 20, 2020
and last updated 2020-03-20 21:28:31-04

SAN DIEGO (KGTV)-- As more people grow weary of the coronavirus pandemic, the race is on to get more test kits in the hands of medical professionals.

Sorrento Valley's Hologic Diagnostic Solutions is making a big dent in the test kit shortage.

Staying at home and away from others is Gov, Gavin Newsom's hope to curb the spread of COVID-19. But that does not curb fear. Many San Diegans still wish to get tested, but health officials say there just isn't enough.

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“The testing situation is frustrating for everyone," Dr. Eric McDonald, Medical Director of Epidemiology and Immunization of San Diego County, said. "There is a shortage of kits.”

Since the Chinese government released the COVID-19 genetic sequencing on Jan. 8, 2020, medical diagnostics companies have been working around the clock to invent a new, efficient test. One of those is Hologic Diagnostic Solutions in Sorrento Valley.

"We started doing exploratory science to figure out, what is the virus, and what can we do to help?" Kevin Thornal, President of Hologic Diagnostic Solutions, said.

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On Monday, the FDA approved Hologic's clinical trials for Emergency Use Authorization. Since then, they have shipped hundreds of thousands of their test kits to their clients, including local hospitals, laboratories, public health systems, and the Department of Defence, for testing military personnel.

“What you’ll see is something like this," Thornal held a small vile. "This is just a small vile that has a nasal swab that looks like a Q-tip. And that will be put up your nose, and they’ll put it into a vile this and send it off to the lab.

Their machines can test up to 1,000 samples in a day, and results come out in about three hours.

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Unlike early manual-style tests, Thornal said Hologic's automated kits take out the possibility of human error. Plus, everything from research and development to production happens here.

“The test was invented by scientists that live here right here in San Diego," Thornal. "And right now, our operations team right here off of Mira Mesa Boulevard, that’s where all of this manufacturing is occurring, is shipping out from here to the globe.”

Hologic said their goal is to send out 600,000 test kits per month, worldwide by April.