Lucira's at Home Molecular Tests Can Detect Omicron (B.1.1.529) SARS CoV-2 Variant of Concern

Rhea-AI Summary

Lucira Health, Inc. (Nasdaq: LHDX) announced that its COVID-19 Check-It and All-In-One test kits can detect 100% of genome sequences of the Omicron variant, as confirmed by evaluation against the GISAID database. These self-test kits provide PCR-quality results at home within 30 minutes and do not require a prescription or additional equipment. Lucira's tests are designed to remain effective amid viral mutations and have shown a 98% accuracy rate in clinical comparisons with high-sensitivity tests. This innovation aims to facilitate safer travel and gatherings during the pandemic.

Positive

• 100% detection rate of Omicron genome sequences confirmed.
• Tests provide PCR-quality accuracy in less than 30 minutes.
• 98% accuracy in clinical trials compared to high-sensitivity tests.

Negative

• None.

• Lucira assessment confirms COVID-19 Check-It (OTC) and All-In-One (Rx) molecular self-test kits' ability to detect 100% of Omicron variant genome sequences analyzed
  
• Lucira assays target viral sequence regions unaffected by the spike protein mutations found in Omicron, Delta and other Variants of Concern
  
• Lucira's tests are the only EUA Authorized, at home self-test kits that deliver PCR quality accuracy and early detectability in a single-use, all-in-one kit with results in 30 minutes or less
  

EMERYVILLE, Calif., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Lucira Health, Inc. ("Lucira Health," "Lucira" or the "Company") (Nasdaq: LHDX), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, announced that its Lucira Check-It (OTC) and All-In-One (Rx) Test Kits can detect Omicron (B.1.1.529), a SARS CoV-2 Variant of Concern.

Lucira Health performs ongoing surveillance of emerging SARS-CoV-2 strains by assessing reactivity against sequence databases. Lucira's evaluation of the Omicron variant (B.1.1.529) demonstrated that Lucira's COVID-19 assay can detect 100% of genome sequences of this variant available in the GISAID database as of November 26, 2021. This confirmation is consistent with previously identified variants including Alpha, Beta, Delta, Gamma, and other sequences that the Company has assessed.

"While there is still a lot to learn about the Omicron variant, the ability to detect circulating strains is fundamental to help slow the virus spread," said Debkishore Mitra, Ph.D., Chief Technology Officer and co-founder of Lucira Health. "This is why our team is relentlessly assessing newly available genetic sequences against our test."

Dr. Mitra continued, "We selected our assay targets to maximize accuracy and to help ensure the assay would hold up in the face of mutations in the spike protein and other fast-evolving genomic regions. We're proud to share it's done exactly that to date, with reactivity to 99.9% of known COVID-19 virus strains."

"At Lucira, we believe you shouldn't have to choose between rapid antigen tests that can't reliably detect infection before symptoms and lab-based PCR tests that can be difficult to access and take days to deliver results," added Erik Engelson, President and Chief Executive Officer of Lucira Health. "We believe our tests' unique ability to deliver PCR-quality results in less than 30 minutes at home make it the test of choice to enable travel, return-to-work, and gathering with family and friends for individuals and companies around the world."

Accurate, easy to use

The LUCIRA™ CHECK IT COVID-19 test kit is designed to deliver PCR quality molecular accuracy in 30 minutes or less at home. Each single-use test kit contains everything needed to conduct one COVID-19 test. It was designed and tested extensively for individuals to use independently and does not require a physician's prescription or supervised assistance. There is no additional equipment such as a reader or instrument to purchase.

In clinical trials, 100% of users successfully performed the test at home in about two minutes using Lucira's easy-to-use 'swab, stir and detect' CHECK IT test kit.

Molecular tests are more sensitive than antigen tests because they amplify critical parts of the viral target. The targeted, molecular amplification that LUCIRA™ CHECK IT and PCR tests employ makes them demonstrably more reliable than "rapid" antigen tests, which can miss active COVID-19 infections.

In a Community Trial setting, LUCIRA™ CHECK IT results were compared with the Hologic Panther Fusion, considered a high-sensitivity molecular test due to its low Limit of Detection ("LOD"). Lucira's accuracy was 98%, detecting 385 out of 394 positive and negative samples correctly when compared to the Hologic Panther Fusion, and excluding ten samples with very low levels of virus (those with very high PCR cycle thresholds of 37.5 or greater) that possibly no longer represented active infection. Comparative positive results agreed 97% of the time among this sample, and negative results agreed 98% of the time..

LUCIRA™ CHECK IT Test Kit

The LUCIRA™ CHECK IT 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 one-page 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. Lucira also offers a free LUCI PASSTM digital verified test result back to a user's phone. LUCI is accessed via text and does not require downloading an app. There is also an opt-in for public health reporting for users who wish to transmit their results to the relevant public health authorities.

Lucira's identical, prescription product is also available for sale to healthcare providers at lucirahealth.com

About Lucira Health

Lucira 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™ CHECK IT COVID-19 Test Kit (OTC) and 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. For more information, visit www.lucirahealth.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "can," "plans," "will," "may," "anticipates," "expects," "potential," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Lucira's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including our ability to increase production, streamline operations and increase product availability; the success of our test platform with COVID-19 including its variants, the impact to our business of the ongoing COVID-19 pandemic; our ability to successfully continue to expand internationally; any impact on our ability to market our products; demand for our products due to deferral of procedures using our products or disruption in our supply chain; our ability to achieve or sustain profitability; our ability to gain market acceptance for our products and to accurately forecast and meet customer demand; our ability to compete successfully; our ability to enhance our product offerings; development and manufacturing problems; capacity constraints or delays in production of our products; maintenance of coverage and adequate reimbursement for procedures using our products; and product defects or failures. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Lucira assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

Investor Contact
Greg Chodaczek
Investorrelations@lucirahealth.com
347-620-7010

FAQ

What is Lucira Health's recent announcement about Omicron detection in LHDX test kits?

Lucira Health confirmed that its Check-It and All-In-One test kits can detect 100% of Omicron variant genome sequences as of November 26, 2021.

How accurate are LHDX's COVID-19 self-test kits?

Lucira's Check-It test kits have shown a 98% accuracy in clinical trials compared to the Hologic Panther Fusion test.

What is the processing time for LHDX's COVID-19 test results?

Lucira's COVID-19 test kits provide results within 30 minutes.

Are Lucira's test kits FDA authorized?

Yes, Lucira's tests are EUA Authorized as at-home self-test kits.

What advantages do LHDX test kits offer compared to traditional tests?

Lucira's test kits deliver PCR-quality results at home without requiring a prescription or additional equipment, making them user-friendly.