Hologic and Quidel Corp. are the latest firms to receive fast-track approval from the U.S. Food and Drug Administration to supply molecular assays lab tests to detect COVID-19.
They join Thermo Fisher Scientific, which received emergency authorization for its coronavirus test late last week. Thermo Fisher's West Coast operations are based in Carlsbad. Spokesman Ron O'Brien said Carlsbad employees are involved but declined to provide details of their role in supplying test kits.
In addition, Carlsbad's GenMark Diagnostics applied last week for emergency authorization from the FDA for its COVID-19 test.
The company is awaiting word on its application. But it is currently shipping coronavirus tests to hospital labs for research use, including Northwell Health Labs in New York.
Delays in testing in the United States have set back the nation's efforts to fight against the pandemic. Federal officials waited until early March to bring private companies into the testing effort. Now they are ramping up. By the end of this week, government officials expect 1.9 million tests should be available.
Hologic applied for emergency FDA authorization for its coronavirus test on Saturday. It was approved on Monday.
Based in Massachusetts, Hologic employs about 1,000 workers in San Diego, where its diagnostics division is based. Hologic acquired San Diego's Gen-Probe in 2012 for $3.8 billion.
The COVID-19 test was developed locally, and it will be manufactured "right here off Mira Mesa Boulevard," said Kevin Thornal, president of the company's Diagnostic Solutions division.
"Right now we're are talking about tens of thousands (of tests) for the remainder of the month of March, scaling up to 600,000 in the month of April," he said. "And we have already made a million-dollar investment that will allow us to increase capacity beyond that in the future."
Hologic's tests run on its proprietary Panther Fusion system — high throughput diagnostic machines about the size of a compact car. Panther Fusion equipment is currently installed in about 100 hospitals and labs in the U.S., including sites in San Diego.
The automated equipment is capable of processing 1,150 tests per day, said Thornal. Results can be ready in as little as three hours.
But that doesn't mean patients necessarily will get their results that fast.
Transporting samples from hospitals, clinics and other remote locations to centralized labs for complex testing typically takes a day or longer, according to experts.
Quidel Corp., which makes diagnostic tests for everything from influenza to strep A to pregnancy, won emergency approval Tuesday from the FDA to supply its molecular assay to detect COVID-19.
"We are proud to have quickly developed this assay in mere weeks, and to have manufactured kits, several of which are in transit to customers," said Quidel Chief Executive Douglas Bryant, in a statement.
Quidel said it anticipates "significant demand" but did not reveal how many test kits it expects to ship to hospitals and laboratories. The company did not respond to requests for comment.
Quidel's Lyra assays are designed for use with existing molecular testing machines, such as the Applied BioSystem's 7500 Fast DX equipment.
GenMark makes smaller, easier to operate testing machines. The company ePlex systems are installed in about 250 hospitals in the U.S. and can deliver results in under two hours.
Because of the quick turnaround and relatively small size, the company expects its system to be used for urgent testing, including patients entering the hospital with advanced symptoms, intensive care patients and health care workers in direct contact with coronavirus patients.
On March 2, the company began shipping COVID-19 detection tests to its Hong Kong distributor and some U.S. hospitals for research use.
"The situation we are in at the moment is that the demand in the U.S. and the world is beyond the current testing capability," said Scott O'Brien, senior vice president at GenMark. "We were the first one to offer this type of testing to the market. I think it shows the power of a local company to provide this test."
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