LUCIRA COVID-19 Test Kit Identifies Viral Variants

LUCIRA COVID-19 All-In-One Test Kit reactive to at least 99.9% of all known COVID-19 virus strains

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.

Each single-use LUCIRA COVID-19 All-In-One Test Kit can conduct one COVID-19 test and be ordered by healthcare professionals from lucirahealth.com.

Sensitive, accurate, easy to use

Lucira’s easy-to-use ‘swab, stir and detect’ test platform demonstrated that 100% of users successfully performed the test in less than about two minutes of hands-on time in usability testing. The current centralized laboratory testing environment takes two to 14 days to generate similarly accurate test results.

Molecular tests are more sensitive than antigen tests because they amplify critical parts of the viral target. The targeted, molecular amplification that LUCIRA COVID-19 All-In-One Test Kit and PCR tests employ makes them demonstrably more sensitive and reliable than “rapid” antigen tests, which can miss active COVID-19 infections.

In a Community-based clinical trial, the LUCIRA COVID-19 All-In-One Test Kit results were compared with the Hologic Panther Fusion, considered one of the highest sensitivity molecular tests due to its low Limit of Detection (LOD). Lucira achieved a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA). Excluding samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieved 100% positive percent agreement. Lucira has since completed an additional Community Testing study among asymptomatic individuals and this data is currently under FDA review.

LUCIRA ALL-IN-ONE Test Kit

The LUCIRA COVID-19 All-In-One Test Kit Test Kit fits in the palm of a hand, extracts genetic material from the virus and amplifies it similar to PCR lab tests. Each Lucira test kit contains everything needed to run one COVID-19 test. Users get the test device, two AA batteries, sample vial, swab and simple instructions. The batteries are inserted into the device and the sample vial is placed in the test unit. The user then opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial, which is then gently pressed into the test unit to start the test. The “ready” light will blink until a “positive” or “negative” green light is illuminated within 30 minutes.

About Lucira Health

Lucira Health is a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits. Lucira’s testing platform produces lab quality molecular testing in a single-use, consumer-friendly, palm size test kit powered by two AA batteries. Lucira designed its test kits to provide accurate, reliable and on-the-spot molecular test results anywhere and at any time. The LUCIRA COVID-19 All-In-One Test Kit (RX) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

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