The Food and Drug Administration has given the green light to the first at-home COVID-19 test, another victory in the fight against the devastating disease.
On Tuesday, the FDA announced that they’d given emergency authorization to the over-the-counter test that has shown promising results, correctly identifying 96 percent of positives and 100 percent of negatives in those experiencing symptoms.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen Hahn said. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”
According to its website, the home test is created by Ellume, a company that develops and manufactures digitally-enabled diagnostic products for healthcare professionals and consumers. The test consists of swabbing your nose and then using a “Bluetooth connected analyzer” to send the results to your smartphone.
Ellume said that the company was planning on making the test at $30 or less over time though their “initial investments in manufacturing are very large, and the initial price may be higher.”
According to the FDA, the company plans to make 20 million of these tests available in the United States within the first few months of 2021, with 3 million produced in January alone.
