LUCIRA™ CHECK IT COVID-19 Self-Test Receives Interim Order Authorization
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 Health Canada issued an Authorization with Conditions for the LUCIRA™ CHECK IT COVID-19 test kit. The Authorization with Conditions was issued by Health Canada under the Interim Order (IO) Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.
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Health Canada issues Authorization with Conditions for LUCIRA™ CHECK IT COVID-19 Self-Test. It is the first self-test authorized by Health Canada for individuals with or without COVID-19 symptoms. (Photo: Business Wire)
The LUCIRA™ CHECK IT COVID-19 test kit is the first self-test authorized by Health Canada for individuals with or without symptoms. It delivers PCR quality molecular accuracy in 30 minutes or less at home and is expected to be available online for Canadians to order by June 2021 for approximately $75.00 CAD, excluding applicable taxes and delivery charges.
Lucira CEO Erik Engelson commented, “Canada has a global reputation for world-class health care. We are proud our self-test was the first one authorized for use within this vast country. Numerous COVID-19 studies have demonstrated that testing improves safety and health, and no other self-test has Lucira’s PCR quality accuracy in such an easy to use form.”
Each LUCIRA™ CHECK IT COVID-19 test kit is a single-use test kit containing everything needed to conduct one COVID-19 test. It can detect a positive result in as few as 11 minutes or confirm a negative result within 30 minutes. It was designed and tested extensively for individuals to use independently and does not require a physician’s prescription or telehealth / supervised assistance.
As with Canada, the LUCIRA™ CHECK IT COVID-19 test kit is the first and only U.S. FDA Emergency Use Authorization (EUA) over-the-counter, single-use, PCR quality molecular test for COVID-19 that can be self-administered at home. Lucira’s test kit is also authorized in the U.S. for prescription at-home and point of care use.
Sensitive, accurate, easy to use
In clinical trials, the LUCIRA™ CHECK IT COVID-19 test kit’s easy-to-use ‘swab, stir and detect’ sequence demonstrated that 100% of users successfully performed the test in less than two minutes. Current centralized laboratory tests can typically take 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™ CHECK IT COVID-19 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 Trial setting, LUCIRA™ CHECK IT 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’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.
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 test kit is designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection. In the US, Lucira also offers the LUCIRA™ COVID-19 All-In-One test kit for point of care and prescription at home use.
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, Lucira’s testing program for select NBA fans. 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. 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.