This FDA EUA first and only PCR quality, single-use, COVID-19 at home, self-test kit is available for $55 to all Amazon US customers
Lucira Health, Inc. (Nasdaq: LHDX), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, today announced that its LUCIRA™ CHECK IT COVID-19 test kit is now available on Amazon.com in the US. Each LUCIRA CHECK IT test kit provides a PCR quality test result at home in 30 minutes or less. After testing, users can also receive a free, text based digital LUCI PASS verified test result on their phone for work or travel. The product costs $55 and includes free standard shipping.
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LUCIRA™ CHECK IT COVID-19 self-test is now available on Amazon. Each test kit provides a PCR quality test result at home in 30 minutes or less. (Photo: Business Wire)
Lucira CEO Erik Engelson said, "We are excited to offer the first at-home COVID-19 self-test to provide an on-the-spot result with molecular accuracy available to millions of US customers on Amazon. We are looking forward to making our test available to more customers thanks to its availability on Amazon."
Lucira Executive Vice President Kelly Brezoczky added, "We’re proud Amazon has made Lucira’s PCR quality over-the-counter COVID test available in its store. We’re making it easy for people to test at home, and then go places with our LUCI PASSTM test result on their phone."
Lucira developed the LUCI PASSTM to provide users an easy way to receive a digital verified test result. Customers simply text the word "LUCI" to 44544 and then follow the simple steps to upload their test results. All test results are digitally verified through LUCI’s secure portal. Once users have a LUCI PASS on their phone they can show their negative test result at entrances to conferences, workplaces, arenas, and for travel and leisure.
The LUCIRA™ CHECK IT COVID-19 test kit is available over the counter (OTC) in the US. LUCIRA’s prescription version was the first U.S. FDA EUA-authorized, prescription, molecular diagnostic test for COVID-19 that can be self-administered by patients at home or used in a physician’s office. It is also the first self-test authorized by Health Canada for individuals with or without symptoms.
Sensitive, 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.
In clinical trials, 100% of users successfully performed self-testing at home in less than two minutes using Lucira’s easy-to-use ‘swab, stir and detect’ CHECK IT test kit. The current centralized laboratory testing environment currently takes two to fourteen days to generate similarly accurate results.
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 instructions. The batteries are inserted in 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 user who wish to transmit their results to the relevant public health authorities.
Lucira still has its identical, prescription product available for sale to healthcare providers at lucirahealth.com
About Lucira Health, Inc.
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 (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.
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. Such forward-looking statements include statements regarding, among other things, the continued availability of Lucira’s test kit on Amazon. 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, which include, without limitation, risks and uncertainties associated with Lucira’s business in general and the other risks described in Lucira’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2021 and subsequent filings made by Lucira with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Lucira undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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