The FDA issued an Emergency Use Authorization (EUA) yesterday for the first prescription molecular diagnostic test for COVID-19 that can be performed entirely at home. Emeryville-headquartered Lucira Health’s single-use test kit can produce a positive or negative result within 30 minutes.
Lucira’s test kit is differentiated by its simple ‘swab, stir and detect’ design. This process takes up to 30 minutes, but a positive test result can be generated in as few as 11 minutes. That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results.
“There are currently two types of COVID-19 tests that detect whether a person is infected and potentially infectious,” said Lucira Health CEO Erik Engelson. “Antigen tests detect viral proteins and can provide results quickly. However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests. Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests, and considered the ‘gold standard’ for determining if someone is infected.”
Lucira’s single-use device has been developed over five years, initially as a flu test kit, that patients would eventually be able to purchase from local drug stores. When the pandemic began early this year, Lucira redirected its efforts to COVID-19.
To validate the test for the FDA, more than 100 people from a broad range of ages, ethnicities and education levels were enrolled in Lucira’s Community Testing Study in Northern and Southern California, including the San Francisco Bay Area. Based on the trial’s design, patients suspected of having COVID-19 tested themselves outside their residences under observation by trained professionals. The community-based trial reported that 100% of the individuals were able to successfully run the test.
While Lucira scales up manufacturing capabilities, its COVID-19 test kit will initially be available on a limited basis in point of care settings and healthcare networks that prescribe the test for patients to use at home. Lucira is committed to making at home testing accessible and anticipates its test will cost around $50.
The Lucira Test Kit is expected to be available to patients served by healthcare providers including Sutter Health in Northern California in the near future. By early spring 2021, it is expected to be available nationally through health care providers.
Located at the Wareham EmeryStation campus on Hollis and 62nd, Lucira Health was founded in 2013 by Debkishore Mitra and John Waldeisen. Lucira’s current CEO is Erik Engelson. They currently have 40 employees.
Read the entire press release on lucirahealth.com.