The U.S. Food and Drug Administration (FDA) is moving much more quickly to grant special ’emergency use authorization’ to equipment and tests that could help increase testing for the novel coronavirus in the U.S., which lags behind most countries in the world when it comes to tests conducted relative to the size of its population. One type of test just approved for use could help expand the availability of frontline testing in hospitals and at clinics where patients are receiving care – without requiring round-tripping to a dedicated diagnostics lab.
Cepheid’s COVID-19 test, which the agency approved this week, also has the advantage of being able to be run either with or without use of a nasal swab, which is key because supplies of nasal swabs are taxed globally in light of the need for testing. It’s also a molecular, PCR-based test, with high rates of accuracy just like the lab-based testing that’s already in place across facilities in the U.S., but it uses the company’s GeneXpert machine (basically a diagnostics kit the size of an inkjet printer cartdrige lab in a box roughly the size of an inkjet printer) to produce results on-site.
Cepheid says that around 23,000 of its GeneXpert micro-labs are already in use around the world, with around 5,000 of those located in the U.S. The company’s hardware has been running tests for the flu for years already, with high reliability rates. The new COVID-19 tests for the system will begin to be shipped out by the Sunnyvale-based molecular diagnostics company starting next week.
Testing in the U.S. has increased over the past week, thanks in large part to widespread efforts to expand availability especially in hard-hit regions like New York State. But the need for more tests is still pressing, as the limits of availability mean that essentially only the most severe cases, often requiring confirmed contact tracing or proof of elevated risk, are being tested. Solutions like Cepheid’s, as well as other potential alternative test methods than can be done entirely at home, like Scanwell’s forthcoming test that looks for antibodies in a person’s blood, are much-needed if we hope to truly expand testing to a degree that it can properly inform any coronavirus mitigation strategy.