- FDA on Tuesday approved an emergency use authorization for the first diagnostic test for COVID-19 that can be purchased over the counter and fully performed at home without a prescription.
- The antigen test from Australia's Ellume detects SARS-CoV-2 virus proteins from a nasal swab sample and delivers results in about 20 minutes to users via smartphone. Unlike similar tests, Ellume's diagnostic is authorized for people with or without coronavirus symptoms and for those as young as 2 years old.
- The company, which developed the test with a $30 million contract from NIH's Rapid Acceleration of Diagnostics (RADx) initiative, is ramping up manufacture of the product and expects to produce more than 3 million tests in January and deliver 20 million to the U.S. within the first half of 2021.
The EUA comes a week after FDA authorized the first non-prescription test that requires a lab to process a self-collected sample. That nod went to laboratory giant LabCorp, which is selling the kit through its Pixel consumer website and may expand into retail channels. LabCorp in April won FDA's first EUA for a COVID-19 diagnostic test with a home collection option, but that kit was only available with a prescription.
Last month, FDA authorized the first prescription COVID-19 test for home use, Lucira Health's molecular test kit for people 14 and older suspected of having the virus. The Emeryville, California-based biotech expects its kit to be available nationally by early spring 2021 through providers and cost $50 or less.
Ellume said its test, which will sell for about $30, correctly identified 96% of positive samples and 100% of negative samples in a multi-site U.S. clinical study of both adults and children above 2 years of age. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.
However, in Tuesday's announcement, FDA emphasized that a small percentage of positive and negative results from the Ellume test may be false, similar to other antigen tests.
"Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible. This is especially true if there are fewer infections in a particular community, as false positive results can be more common when antigen tests are used in populations where there is little COVID-19 (low prevalence)," according to the agency.
Jeff Shuren, director of FDA's Center for Devices and Radiological Health, also noted that the Ellume test is less sensitive and less specific than typical molecular tests run in a lab, which is also the case for other antigen tests. "However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic," Shuren said in a written statement.
The Ellume COVID-19 Home Test includes a sterile nasal swab with child adapter, a dropper, processing fluid and an analyzer. The sample must be collected further back than with the usual nasal swab, but not as far back as with the nasopharyngeal swabs used by healthcare providers. A Bluetooth-enabled app connects with the analyzer to walk the user through the instructions for performing the test and reading the results.
FDA said it has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that involve home collection of samples that are sent to a lab for processing.