EMERYVILLE, Calif.– Lucira Health, Inc. (Nasdaq: LHDX), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, today confirmed it can successfully identify the “double mutant” variant of COVID-19 with its Lucira molecular test kit.
The “double mutant” variant was first identified in India on March 24, 2021, and found in California on March 25, 2021, by Stanford Clinical Virology Lab scientists. Unlike other variants, it has two genetic mutation sequences that the Center for Disease Control (CDC) is tracking.
According to Lucira Health Chief Technology Officer and co-founder Debkishore Mitra, Ph.D., variants occur when viruses replicate themselves. These variants include well-known strains first discovered in England, South Africa, and Brazil. Variants can occur when the genetic code packaged inside the virus starts copying itself and the new copies inadvertently start replicating a new, mutant code. These errors can cause a virus to elude the immune system and become more challenging to detect.
“A test is only helpful if it can detect the virus it’s designed to find,” said Dr. Mitra. “That’s why we started routinely monitoring COVID-19 viral variants, even before the FDA’s voluntary guidelines were released this February. As sequences from new virus strains become available, we compare their genetic code with our test using a well-established, extremely accurate computer model.
“Since we began this monitoring, our Lucira test kit has been reactive to more than 99.9% of available COVID-19 viral sequences, which are roughly 30,000 letters long. It’s complex work, but really important since users rely on our test for accurate results.”
Dr. Mitra added, “Our focus is on providing a test that’s easy for an individual to use and extremely accurate. If someone uses our ‘gentle swab’ test and has COVID-19, they can know in as few as 11 minutes on-the-spot. If they are not infected, they will know within 30 minutes. Precision and performance matter, and we can’t afford to let any variants escape detection.”
Lucira Health’s U.S. designed and manufactured product was the first FDA-authorized, prescription, molecular diagnostic test for COVID-19 that could be fully self-administered by patients at home or used in a physician’s office. Results are produced on-the-spot.
