FDA authorizes combination flu-COVID test for home use
The FDA announcement came two days after Lucira filed for Chapter 11 bankruptcy. Above, the FDA building on the agency's campus in Silver Spring, Md. Credit: AP/Jacquelyn Martin
The Food and Drug Administration has approved the first over-the-counter test for both flu and COVID-19, but the company that makes it recently filed for bankruptcy, raising questions about when the at-home test might become available.
The test by Lucira Health will be able to be purchased without a prescription and can tell the difference between COVID-19 and the flu with a single nose swab, with results in about 30 minutes, the agency said.
Dr. Jeff Shuren, the director of the FDA's device division, called the test, which received emergency use authorization Friday, "a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home."
Dr. David Hirschwerk, medical director of North Shore University Hospital, said the at-home test would make diagnosis easier and more convenient for people.
"A rapid test that can accurately distinguish the virus that somebody has would be welcome, and very helpful," Hirschwerk said Saturday.
The test would have been useful during the height of the flu season but would currently have limited value as the season winds down, Hirschwerk said.
The FDA announcement came two days after Lucira filed for Chapter 11 bankruptcy. Company officials said they had anticipated receiving FDA approval last August, in time for the 2022-23 flu season. Without that seasonal revenue, Lucira had to cut costs, reduce its workforce and eventually file for bankruptcy, according to a company statement.
Erik Engelson, president of the California-based company, said in a statement that Lucira intends to "move forward in normal course [of] operations, while concurrently pursuing a sale process."
But the bankruptcy casts a shadow over the company's future, said Anna Bershteyn, an assistant professor at the NYU Grossman School of Medicine.
"If a company goes bankrupt, that's not a good sign" on getting out a product, Bershteyn said.
Company officials have not said when the combo test will come to market, or what the price will be.
Bershteyn said companies making medical diagnostic tools face a "tricky" market in which demand can quickly change.
"The [pharmaceutical] space is a weird space. You either make it big or die," Bershteyn said. "We see a lot of bankruptcies."
Long Islanders learned that lesson Thursday, when the pharmaceutical company Akorn Operating Company LLC filed for bankruptcy and laid off all its employees, including 303 people at its Amityville plant.
Still, Bershteyn said the medical field is undergoing a "revolution" in diagnostic tools available for home use, from telemedicine visits to at-home EKG kits.
"The other day my child had an ear infection and we didn't want to take her out," Bershteyn said. She said she bought an over-the-counter ear scope and had a telemedicine visit in which the doctor was able to see inside the girl's ear and make a diagnosis.
"We're seeing a wonderful movement where we're putting more tools in the patient's hands," she said. "It's so much more convenient."
Craig Schneider is a Long Island native and Stony Brook University alumnus. He joined Newsday as a general assignment reporter in January 2018 after 20 years at the Atlanta Journal-Constitution.
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