Lucira™ Health Commits 2 Million At-Home Molecular COVID-19 Test Kits on Amazon
Lucira Health (LHDX) announced over two million at-home COVID-19 test kits are now available on Amazon, providing rapid results with PCR-quality accuracy. Priced at $75, the Lucira Check-It test offers results in 30 minutes, a significant improvement over traditional lab tests. With a high accuracy rate of 98% compared to lab-based PCR tests, and the ability to detect all Omicron variant genome sequences, this innovative testing solution aims to alleviate overwhelmed testing sites. The test is FDA-authorized and available without a prescription.
- Availability of over two million Lucira Check-It COVID-19 tests on Amazon supports broader public access.
- The test boasts a 98% accuracy rate in comparison to standard lab PCR tests.
- Results can be obtained in just 30 minutes, enhancing user convenience.
- Eligible for reimbursement from private insurers, potentially increasing demand.
- None.
EMERYVILLE, Calif., Feb. 3, 2022 /PRNewswire/ -- Lucira Health, Inc. ("Lucira Health" or "Lucira") (Nasdaq: LHDX), a medical technology company focusing on the development and commercialization of transformative and innovative infectious disease test kits, announced more than two million Lucira™ Check-It COVID-19 tests, a rapid at-home test with PCR-quality accuracy, are available on Amazon.com. Lucira's tests are available with 1-2 day Prime delivery nationwide.
Nationwide surges of COVID-19 cases have resulted in overwhelmed testing sites and processing labs, making accurate at-home test options more critical than ever. Lucira's innovative tests uniquely combine the speed and at-home usability of rapid antigen tests and the accuracy and early detection of PCR. Lucira's tests are amplification tests, meaning they amplify virus genetic material, just like PCR tests, but are miniaturized to fit in the palm of your hand and were shown to be
"We have worked tirelessly to ensure Lucira Check-It COVID-19 tests are more accessible to the public," said Erik Engelson, Lucira Health's Chief Executive Officer. "Access to a COVID-19 test with PCR-level accuracy and early detectability, previously only available from a lab test, in 30 minutes without leaving your home can help Americans confidently return to work or school and get back to gathering in-person with family and friends. Amazon's distribution network enables more people in the United States to access this innovative and unique testing solution."
The test kit, the first and only single-use at-home amplification test authorized for emergency use by FDA, is available over the counter ("OTC") and can produce a positive result in as little as 11 minutes, or a negative result within 30 minutes. Immediately after testing, users can access a free, text-based digital LUCI PASS™ verified test result on their phone.
The Check-It COVID-19 test kit costs
The Lucira Check-It COVID-19 test kit has emergency authorization by FDA under EUA.
LUCIRA™ Check-It Test Kit
The Lucira™ Check-It (OTC) test is a Nucleic-Acid Amplification Tests (referred to as NAAT). The test fits in the palm of your hand, extracts genetic material from the virus and amplifies 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.
In a community trial setting, Lucira™ Check-It results were compared with the Hologic Panther Fusion, which is considered a high-sensitivity molecular test due to its low Limit of Detection ("LOD"). Lucira's accuracy was
Lucira has announced confirmation that its COVID-19 Check-It molecular self-test kits can detect
Each Lucira test kit contains everything needed to run a single 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. In the US, 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,
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 Lucira's ability to increase production, streamline operations and increase product availability; the success of Lucira's test platform with COVID-19 including its variants; the extent and duration of the COVID-19 pandemic and Lucira's expectations regarding customer and user demand for its COVID-19 test kit; Lucira's ability to obtain and maintain regulatory approval for its test kits, including Lucira's existing Emergency Use Authorization for its COVID-19 test kits; the performance of, and Lucira's reliance on, third parties in connection with the commercialization of its test kits, including Jabil Inc. and Lucira's single-source suppliers; Lucira's ability to successfully continue to expand internationally; any impact on Lucira's ability to market its products; demand for Lucira's products due to deferral of procedures using its products or disruption in its supply chain; Lucira's ability to achieve or sustain profitability; Lucira's ability to gain market acceptance for its products and to accurately forecast and meet customer demand; Lucira's ability to compete successfully; Lucira's ability to enhance and expand its product offerings; Lucira's ability to accurately predict continued expansion; Lucira's ability to accurately forecast revenue; development and manufacturing problems; capacity constraints or delays in production of Lucira's products; maintenance of coverage and adequate reimbursement for procedures using Lucira's products; and product defects or failures. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in Lucira's filings with the Securities and Exchange Commission and available at www.sec.gov, including in its 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.
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SOURCE Lucira Health
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