- FDA late Tuesday announced it granted Emeryville, California-based biotech Lucira Health an emergency use authorization for the first coronavirus diagnostic test for complete self-testing at home.
- Lucira's single-use molecular test kit delivers results in 30 minutes or less and is authorized for prescription home use with self-collected nasal swab samples for people age 14 and older suspected to have COVID-19 by their healthcare provider. The company expects its testing kit to cost about $50 and to be available nationally by early spring 2021 through providers.
- Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement that individuals "will be able to take immediate action, based on their results, to protect themselves and those around them."
While FDA has previously authorized COVID-19 diagnostic kits that allow an individual to self-collect a sample at home, Lucira's is the first test that can also provide results at home without being processed at an outside lab.
Some public health experts see widespread availability of in-home self tests as having the potential to dramatically increase the nation's capacity for coronavirus testing, while relieving some of the pressure on labs and healthcare systems as the U.S. this week reported a daily average of nearly 160,000 new COVID-19 cases.
Though Lucira's test is expected to be available nationally by early spring 2021 through healthcare providers, the molecular diagnostic will be first made available in the "near future" to patients of Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale.
Still, Michael Mina, a professor of epidemiology at Harvard's T. H. Chan School of Public Health, has previously expressed concerns that even with an EUA for a fully at-home test it might not be "massively produced" initially in sufficient numbers needed for mass screening.
Mina also contends there's been no effort to date from FDA and CDC to provide "serious guidance" about how these kinds of tests could be deployed and used by consumers. "I worry that we are going to have a haphazard rollout of them," he said.
Early in the pandemic, FDA raised concerns over whether the average consumer could safely and correctly collect a nasal specimen for COVID-19 testing. However, Shuren said a diagnostic that "can be fully administered entirely outside of a lab or healthcare setting has always been a major priority" for the agency, which is continuing to work with test developers to "support the availability of more at-home test options.”
The test involves swirling a self-collected nasal swab sample in a vial that is placed in the testing unit. A light-up display then shows whether a person is positive or negative. A positive test result can be generated in as few as 11 minutes, according to the company.
FDA noted in its EUA announcement that "prescribing healthcare providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state and federal requirements. To help providers with reporting, the agency said Lucira Health has developed box labeling and quick reference instructions. It remains to be seen if consumers will follow through on that reporting.
As for the broader category of potential at-home tests, some infectious disease experts think there remains an open question as to whether consumers who test positive will report the results to their healthcare providers.
When it comes to accuracy, Lucira's website claims its at-home rapid COVID-19 test is comparable to the polymerase chain reaction (PCR) gold standard for detecting SARS-CoV-2 infections. Lucira contends its diagnostic, which uses a method called loop mediated amplification reaction (LAMP), was able to accurately detect 94% of infections found by "one of the most reliable FDA authorized" PCR tests, and also correctly identified 98% of the healthy, uninfected people in a clinical trial.
In addition to the milestone at-home testing, FDA said Lucira's test is also authorized for use in point-of-care settings for all ages. However, when the diagnostic is used as a POC test for individuals younger than 14 years old, the agency said samples must be collected by a healthcare provider.