Now that we’ve all been trained to take nasal swabs for COVID-19, we’ll soon have the opportunity to do it for the flu at the same time as well.
The Food and Drug Administration legalized the first over-the-counter home control that can trip and differentiate the outcome of a flu control from a COVID-19 control outcome.
The Lucira COVID-19 and flu home control is a single-use control, which can be purchased without a prescription. A nasal swab is used as for a COVID home checkup; within 30 minutes or less, the test shows positive or negative effects for influenza A, influenza B, and COVID-19.
“Today’s authorization of the first over-the-counter screening capable of detecting influenza A and B, as well as SARS-CoV-2, is a major step in customers’ access to diagnostic checks that can be performed entirely at home,” said Dr. Jeff Shuren. , director of the FDA’s Center for Devices and Radiological Health, in Friday’s announcement.
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Lucira Health began manufacturing its COVID-19 and flu test in Canada in August 2022 and its current value is around $70.
The insurance policy can also determine how much consumers pay.
Lucira Health to Announce U. S. Value Labeland a release date at a later date, corporate chairman and CEO Erik Engelson told USA TODAY. carry this out and, of course, for FDA recognition,” he said.
The company also recently sold a Lucira Check It COVID-19 test ($34. 99), which is a molecular test, similar to polymerase chain reaction (PCR) lab tests, and more accurate than other immediate at-home antigen tests.
In addition to Canada, home checks for COVID and flu can already be performed in Australia and Europe (the screening that will be performed there also checks the RSV), according to the medical site WebMD.
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The FDA said the check identified:
Lucira Health, a medical generation company founded in Emeryville, California, was hoping to get an emergency use provision from the FDA around the same time Canada gave it approval.
Production had already started to meet expected demand, as demand for its COVID-19 declined. Without the expected profit from CombinedArray, the company filed for Chapter 11 bankruptcy and plans to proceed with the sale of the company. announced on February 22.
“Unfortunately, as restrictions eased in 2022, we saw a decrease in the request for COVID-19 verification. This, combined with slower-than-expected regulatory approval for the new combined verification kit developed for the 2022-2023 flu season, has led to inadequate earnings and capitalization to offset expenses,” Engelson said in the bankruptcy announcement. “Despite all efforts to reduce capital expenditures and restructure our business, we have taken this step to maximize the price of our assets.
In January, the company announced the addition of a Medi-Call telehealth call with the acquisition of its COVID-19 and flu in Canada.
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