FDA authorizes first COVID-19 test for self-testing at home

Yesterday afternoon, the U.S. FDA issued an Emergency Use Authorization (EUA) to a COVID-19 molecular diagnostic test that provides individuals with a result within 30 minutes, in the comfort of their home.

As opposed to currently available at-home testing products, which have patients self-collect a nasal swab sample and ship it for processing in a lab, the Lucira COVID-19 All-in-One Test Kit includes all the materials and instructions necessary for individuals to conduct the test themselves.

To do so, they self-collect a nasal swab sample and then swirl it within an included sample vial, according to the FDA EUA letter. The vial is then placed into a battery-powered test unit device that eventually displays an LED light next to the positive or negative indicator (or a light next to each one, if the test was inconclusive).

The single-use test requires a prescription, and is intended for home use among those aged 14 years or above with suspected COVID-19. The kit is also authorized for use in a point-of-care setting, but in that case a provider must collect samples when the test is used for those under the age of 14.

Lucira said in its announcement that it anticipates the test will cost roughly $50, and will initially have limited availability.

The platform had been under development for about half a decade as a flu diagnostic, the company said. The company then shifted gears to COVID-19 earlier this year. It’s also aiming to update its EUA or file a new EUA by Q2 2021 to allow for online consultation and overnight delivery of the kit.

WHAT’S THE IMPACT?

Lucira said that it validated the All-in-One Test Kit in a study of “more than 100 people from a broad range of ages, ethnicities and education levels” from California. In the study, 100% of participants with suspected COVID-19 were able to conduct the test themselves under observation and out of the home. Positive results from the company’s test were in 94.1% agreement with another FDA-authorized COVID-19 assay, Lucira said, while negative results were in 98% agreement.

The U.S. is facing down a winter wave of new COVID-19 cases, and demand for in-person testing services is again on the rise. A new option that not only keeps infectious patients away from long lines, but also provides a prompt result, can help cut down new transmissions of the disease and more quickly connect patients to care.

“A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.

“We look forward to proactively working with test developers to support the availability of more at-home test options.”

THE LARGER TREND

2020’s COVID-19 pandemic has been paired with a flurry of EUAs and other unusual regulatory moves out of the FDA. While this has led to some confusion among home testing startups, especially early in the pandemic, the agency has authorized a total of 288 tests (233 molecular, 58 antibody and seven antigen) as of Nov. 17.

Several EUA’s over the course of the year broke new ground for how providers, organizations, public health programs and patients could receive results. These included LabCorp’s home collection RT-PCR test, which received an EUA in April; a July update that allowed the same test to handle asymptomatic and pooled testing; a home-collected saliva sample platform authorized in May; and Abbott’s $5 rapid test, issued its EUA in late August.

Not to be lost in the mix is Cue Health’s connected testing platform, a rapid molecular test that was authorized in June, but received $481 million from HHS and the Department of Defense to ramp up production.

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