Lucira™ Check-It PCR-Quality, At-Home Molecular COVID-19 Test Now Available in the Optum Store

• Lucira’s COVID-19 test is the only EUA authorized rapid at-home self-test that delivers PCR accuracy and early detectability in a single-use test kit with results in 30 minutes

• Availability in the Optum Store expands access to this unique testing option amidst a surge of US COVID-19 cases caused by the Omicron variant
• Lucira’s test uniquely offers PCR accuracy and early detection without the 24 hour+ wait for results

EMERYVILLE, Calif., Jan. 11, 2022 (GLOBE NEWSWIRE) — Lucira Health, Inc. (“Lucira Health” or “Lucira”) (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 PCR-Quality, At-Home Molecular COVID-19 Test is now available in the Optum Store (store.optum.com).

“Expanding access to Lucira’s first-of-its-kind test is critical in the face of the current surge of COVID-19 cases. Our at-home molecular test delivers the lab-quality accuracy of PCR combined with the rapid, on-the-spot results of antigen tests, so you can detect early COVID-19 infection, including Omicron, before potentially putting others at risk,” said Erik Engelson, President and Chief Executive Officer of Lucira Health. “The Optum Store connects consumers with high-quality, affordable health products and services to improve their overall health and care, and we’re proud to offer our tests to their customers.”

The Lucira Check-It COVID-19 test kit has emergency authorization by FDA under EUA.

Lucira™ Test Kits

The Lucira™ Check-It (OTC) and All-In-One (Rx) test kits are molecular Nucleic-Acid Amplification Tests (referred to as NAAT). The tests fit in the palm of your hand, extract genetic material from the virus and amplify it, similar to PCR lab tests, to detect the presence of virus earlier and more accurately than antigen tests. The test uses an approach called reverse transcriptase loop-mediated isothermal amplification (“RT-LAMP”). 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 to purchase, such as a reader or instrument.

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 five times in each nostril. 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 Pass™ digital verified test result back to a user’s phone. LUCI Pass™ 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.

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.

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%, correctly detecting 385 out of 394 positive and negative samples in comparison to the Hologic Panther Fusion, 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.

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 extent and duration of the COVID-19 pandemic and our expectations regarding customer and user demand for our COVID-19 test kit; our ability to obtain and maintain regulatory approval for our test kits, including our existing Emergency Use Authorization for our COVID-19 test kits; the performance of, and our reliance on, third parties in connection with the commercialization of our test kits, including Jabil Inc. and our single-source suppliers; 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 and expand our product offerings; our ability to accurately predict continued expansion; our ability to accurately forecast revenue; 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