LumiraDx Fast Lab Solutions Partners with Audere for At-Home Self- Collection Solution for use with SARS-CoV-2 RNA STAR Complete
LumiraDx (NASDAQ: LMDX) has partnered with digital health non-profit Audere to launch a self-collected COVID-19 nasal specimen collection kit, authorized for use with the LumiraDx SARS-CoV-2 RNA STAR Complete assay. This collaboration aims to increase testing accessibility, allowing laboratories to integrate Audere's HealthPulse@home solution. The STAR Complete assay is currently authorized for emergency use by the FDA. This initiative aligns with LumiraDx's commitment to providing efficient and accessible testing solutions in various healthcare settings.
- Partnership with Audere enhances access to COVID-19 testing.
- Integration of HealthPulse@home allows labs flexibility in specimen collection.
- The collaboration aims to support high-quality, cost-effective testing solutions.
- LumiraDx SARS-CoV-2 RNA STAR Complete has not received FDA clearance or approval.
- The emergency use authorization is contingent on the ongoing declaration of circumstances warranting it.
LONDON, Dec. 15, 2021 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX) today announced a partnership with digital health non-profit Audere, to offer a self-collected COVID-19 nasal specimen collection kit that has been authorized for use with the LumiraDx SARS-CoV-2 RNA STAR Complete assay to process self-collected samples. Audere's testing solution, HealthPulse@home, closely aligns with LumiraDx's continual efforts to increase testing access and support a growing number of testing needs.
Laboratories utilizing the SARS-CoV-2 RNA STAR Complete will be able to integrate HealthPulse@home into their systems. Using HealthPulse@home authorized labeling instructions, labs can provide their own specimen collection kit solution that fits into the lab's preference of kit registration, accessioning, and flexibility of shipping carriers. The HealthPulse@home solution is designed for efficiency and simplicity and requires no additional usability studies.
Sanjay Malkani, President, LumiraDx Fast Lab Solutions stated, "With the recent FDA EUA Intended Use expansion on the LumiraDx SARS-CoV-2 RNA STAR Complete, we are bringing access to innovative testing solutions right to the community - whether through high sensitivity mobile molecular labs or through the convenience of superior, simple, remote self-collection technologies with Audere. By working with Audere, and providing remote collection, we further enable high quality, cost-effective, convenient, and accurate testing that fits into the needs of the clinic and individuals."
Paul Isabelli, Chief Operating Officer, Audere, stated "We are excited to partner with LumiraDx and further its mission to provide quality and highly accessible testing solutions that fit the needs of the Lumira Dx Fast Lab Solutions network and the clinics and individuals it serves. The use of HealthPulse@home in conjunction with LumiraDx SARS-CoV-2 RNA STAR Complete will broaden access to self-testing solutions, allowing individuals to confidently continue on the path to normalcy."
EUA Status of LumiraDx SARS-CoV-2 RNA STAR Complete
The LumiraDx SARS-CoV-2 RNA STAR Complete has not been FDA cleared or approved but has been authorized by FDA for emergency use under an EUA for use by authorized laboratories. The LumiraDX SARS-CoV-2 RNA STAR Complete has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
About LumiraDx Fast Lab Solutions
LumiraDx Fast Lab Solutions is a dedicated LumiraDx business unit that supports high-complexity laboratory testing by utilizing its innovative qSTAR nucleic acid amplification technology in an accessible high-throughput format to leverage current molecular laboratory operations. Utilizing Fast Lab Solutions enables laboratories to improve efficiency and reduce time to result.
About LumiraDx
LumiraDx (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease. LumiraDx has on the market and in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform. In addition, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-efficient COVID-19 testing solutions from the lab to point of need.
LumiraDx is based in the UK with more than 1600 employees worldwide.
Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com
About Audere
Audere is a Seattle-based digital health nonprofit developing solutions to improve global health outcomes in the world's most underserved communities. Our team of passionate, innovative minds advances health equity by revolutionizing the detection and treatment of diseases, such as malaria, COVID-19, and HIV. Through a deep understanding of key global health needs, Audere combines smartphone technology, computer vision & machine learning, and the best of cloud-based services to deliver tailored healthcare technology solutions worldwide. Development of our projects is funded by grants from the Bill & Melinda Gates Foundation and Justworks. Learn more at auderenow.org.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the integration of the LumiraDx SARS-CoV-2 RNA STAR Complete Audere's technologies and the associated benefits and synergies. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including, among others, general economic, political and business conditions; the effect of COVID-19 on LumiraDx's business and financial results; maintaining EUA approval for the LumiraDx SARS-CoV-2 RNA Star Complete and those factors discussed under the header "Risk Factors" in the Proxy Statement and Prospectus filed pursuant to Rule 424B(3) with the Securities and Exchange Commission ("SEC") on September 10, 2021 and other filings with the SEC. Although LumiraDx believes that it has a reasonable basis for each forward-looking statement contained in this press release, LumiraDx cautions you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which it cannot be certain. LumiraDx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Media Contact:
Colleen.McMillen@lumiradx.com
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