Coronavirus test gets emergency approval by US FDA

Chris Davies - Feb 5, 2020, 9:34 am CST
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Coronavirus test gets emergency approval by US FDA

A new coronavirus test has been fast-tracked to approval in the US, with the FDA giving the green light to broader use of a diagnostic panel that can identify the disease. The US Food and Drug Administration used an emergency use authorization (EUA) to allow more widespread testing with what was previously a diagnostic limited to official government labs.

The 2019-nCoV Real-Time RT-PCR Diagnostic Panel had been in use already, but only at Centers for Disease Control and Prevention (CDC) labs. It relies on respiratory secretions from nasal or oral swabs, with a so-called reverse transcriptase polymerase chain reaction indicating whether the sample comes from someone infected by the new coronavirus.

Even now, though, the EUA doesn’t mean you’ll be able to head down to your local Walgreens or CVS and pick up a coronavirus test off the shelf. Use of the diagnostic panel will be limited to qualified laboratories designated to the CDC; in the US, they’ll need to be certified to perform high complexity tests, too. It’s also worth not in that the test isn’t infallible, and even if it comes back negative there could still be 2019-nCoV infection.

Coronavirus has arguably spread more panic than it has actual disease at this stage, at least in the US. Identified first in Wuhan, China, in December 2019, links to travel from that area are still the primary connection to those who have come down with the virus. “At this time,” the FDA says, “federal health officials continue to believe that the threat to the general American population from this virus is relatively low.”

All the same, the Administration was under pressure to speed up diagnostics for possible cases, not least because of the coronavirus’ relatively extended period between infection and symptoms being displayed. The HHS declared it a public health emergency on January 31, 2020.

With no commercially-available diagnostic test, the EUA was seen as the next best thing. Indeed, the CDC requested these broader approvals for the test. Anybody who considers themselves a potential risk for coronavirus should seek advice from their health care provider.

Symptoms of 2019-novel coronavirus (2019-nCoV) are similar to those of flu, and include fever, coughing, and difficulty breathing. The FDA is also working with other diagnostic developers to fast-track more tests that can be used to speed up the process, as well as treatments and preventatives.


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