Regulatory FDA approves first-ever at-home test for both COVID and...

FDA approves first-ever at-home test for both COVID and Flu


The first over-the-counter, at-home test that can identify both COVID-19 and influenza has received emergency use authorization from the Food and Drug Administration. 

The FDA has allowed Lucira Health to market and sell its at-home test, the COVID-19 & Flu Home Test is available without a prescription and consists of a testing device that checks a nasal swab sample for SARS-CoV-2 and influenza A and B. Children up to two years will be evaluated using samples obtained by an adult whereas users older than 14 may collect their samples.

About three years after approving its first-ever EUA for a coronavirus diagnostic—a high-volume lab test from Roche that received the go-ahead just 24 hours after submitting its application—late last week, the FDA made history once more. This time, the EUA was granted the first ever at-home, over-the-counter test that could simultaneously identify COVID-19 and the flu, making it the first test ever approved to do so.

Jeff Shuren, Director of the Center for Devices and Radiological Health at FDA, stated in the release:

“The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs.”

According to the FDA, the test identified positive COVID-19 and influenza A diagnoses in roughly 88% and 90% of patients, respectively.

As there are not enough instances of the strain presently circulating, the diagnostic’s capacity to detect positive cases of influenza B in the real world could not be evaluated by the researchers. The FDA claims that the test was still able to detect the virus in contrived specimens, and the EUA has ordered the test developer to keep gathering real-time influenza B samples for additional testing.

Emergency authorizations from the COVID period are nothing new to Lucira. It was the first test maker to be granted a EUA in November 2020 for a coronavirus diagnostic that could be used at home, albeit a prescription was still necessary. The molecular test is conducted using a single-use testing device that was previously developed as the possible flu solution.

At the start of 2021, Lucira went public through an IPO that raised around $153 million, well before the $50 test’s commercial introduction. Since then, the business has faced several financial challenges because of a decrease in COVID-19 testing. It just recently filed for Chapter 11 bankruptcy, with CEO Erik Engelson blaming the FDA’s protracted approval process for the combination test as a key contributor to the company’s declining profitability.

The CEO of Lucira has blamed the extensive authorization process of the FDA as the main reason for bankruptcy. The company explained that as it was not sure when will they receive the regulatory license approval, they had built inventory for an anticipated autumn 2022 launch, which would have been particularly helpful during the current respiratory season. 

Lucira is looking for a financial partner who may assist in resuming the production and development of further at-home medications.

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