We have developed a hand-held testing platform that produces PCR quality molecular results in a single-use, consumer-friendly test kit powered by two AA batteries. The Lucira Check It COVID-19 Test Kit--available over the counter--and Lucira COVID-19 All-In-One Test Kit--available with a prescription--are designed to provide a clinically relevant COVID-19 result at-home within 30 minutes from sample collection. Our platform has four key attributes: (1) robust target identification, (2) colorimetric assay, (3) consumer-friendly test kit and (4) flexible assay architecture. We utilize molecular assays to amplify and detect the target through a combination of loop-mediated isothermal amplification, or LAMP, and proprietary colorimetric detection chemistry. These assays are then stabilized and packaged inside the hardware utilizing a flexible architecture to allow for multiplexed detection. Our simple and intuitive test kits are designed for high usability and high accuracy while also being purpose-built for low-cost manufacturing.
Current standard of care tests fall into one of three categories: molecular tests, antigen tests and antibody tests. Molecular tests have superior sensitivities among the testing modalities and therefore can identify contagious people earlier. Molecular testing infrastructure in the United States does not meet the immediate demands of infectious disease management on a mass-population scale. It relies on centralized testing that involves complex sample transportation, logistics, and throughput bottlenecks, taking two to 14 days to return a result. More recently, benchtop instruments have been developed to perform these complex and sensitive molecular tests in the Point of Care setting, but these tests still require a healthcare operator and dedicated instrumentation which limits their portability and throughput. Antigen tests have emerged as a category of stopgap tests that address the needs for portability and affordability. However, they tend to generally have low sensitivities, often missing early positives when viral loads are not yet high enough to be detected by an antigen platform. Antibody tests have limited clinical relevance because they do not test for active infection and therefore do not indicate whether a person is actively contagious. Lucira’s COVID-19 test kit became the first ever FDA EUA authorized at-home molecular test for any disease state. We designed our test kit to mitigate the shortcomings of both molecular lab-based and antigen testing to provide a portable, accessible, accurate and easy to use at-home test for infectious diseases. We believe that at-home molecular testing will be the third generation of molecular diagnostic testing.
The Lucira Check It COVID-19 Test Kit--available over-the-counter--is a direct-to-consumer and a business-to-business product. The Lucira COVID-19 All-In-One Test Kit--available with a prescription--is a direct-to-physician, hospital/clinic, and business-to-business product. Business and non-profit buyers are diverse, because of the great need for accurate, reliable and on-the-spot COVID-19 molecular test results. They include employers, film productions, professional sports team organizations, homeless shelters, summer camps, schools, religious organizations, and distributors. End users are individuals with or without COVID-19 symptoms aged 2 and older. Individuals aged 14 years and older can self-collect nasal swab samples, while an adult--for Lucira Check It--and a healthcare professional--for Lucira All-In-One--run the test for children aged 2-13.
Lucira Check It COVID-19 Test Kits helped to safely reopen the Chase Center to Golden State Warrior fans. Here’s an article for more details: https://www.businesswire.com/news/home/20210422005691/en/ The Lucira test was also used to support pre-travel testing for US athletes participating in the Tokyo Olympics. Here is the link for that testing: https://www.meenta.io/product/tokyo-games-pretravel-testing/ Our test kit has 4.7/5 stars on Amazon with 97 reviews. Here is a customer testimonial: “This is a great product! It’s super easy to use and getting the results so quickly from a test as accurate as you get in a doctor’s office is amazing. Spending time with elderly family, it has given me peace of mind that I am covid free for the visit. Now that I’m vaccinated, I still bought a couple extra to use in the event I don’t feel well, I can rule out mild covid symptoms.” *Please note: for the question regarding FDA approval, Lucira’s technology has received FDA Emergency Use Authorization (EUA)
When Lucira received authorization, the FDA Commissioner noted, “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.” Lucira’s test is groundbreaking as the first at-home molecular test and fills an unmet need for decentralized, accessible, high accuracy testing.