FDA Reissues LumiraDx Fast Lab Solutions' EUA for SARS CoV-2 RNA STAR Complete Molecular Reagents to Allow High Throughput and Asymptomatic Testing Solutions
LONDON, Dec. 1, 2021 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX) announced today that the intended use for its Food and Drug Administration (FDA) Emergency Use Authorization (EUA) SARS-CoV-2 RNA STAR Complete, a rapid, nucleic acid amplification technology for high sensitivity, high throughput COVID-19 testing has been reissued. The EUA now includes (1) testing of asymptomatic individuals, (2) pooling of up to five individuals, (3) access to 384-well configuration on validated open RT-PCR systems and (4) inclusivity of the detection of the novel SARS-CoV-2 Omicron variant (B.1.1.529). LumiraDx SARS-CoV-2 RNA STAR Complete, developed with proprietary qSTAR technology, utilizes a single step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments, with results within 20 minutes. In clinical studies, the performance of LumiraDx RNA STAR Complete with asymptomatic individuals had a 95.2% positive agreement and 100% negative agreement when compared to another high sensitivity RT-PCR assay. In addition to the expanded intended use to include testing of asymptomatic individuals, the FDA authorized the company's high throughput initiatives with a pooling claim and access to open RT-PCR 384-well systems, therefore providing laboratories an economical and scalable pathway to rapidly support increase in testing capacity and allow for same day result reporting. Sanjay Malkani, President, LumiraDx Fast Lab Solutions stated, "Welcome to the new era of mass molecular testing solutions for high complexity centralized, stat and mobile labs. With the EUA Intended Use expansion on the LumiraDx SARS-CoV-2 RNA STAR Complete, we introduce the world to high throughput, efficiency, and performance while leveraging existing validated open RT-PCR systems. Whether centralized or on the go, with new innovations such as high complexity mobile labs capable of performing 2000 molecular tests per hour with only two operators, we credibly demonstrate the innovation of the qSTAR technology with equivalent analytical performance to the legacy nucleic acid amplification technologies." He continued, "With this revised EUA, allowing asymptomatic screening, pooling and use in 384-well RT-PCR systems, we enable laboratories to substantially increase the accessibility and affordability of COVID-19 molecular screening in community testing programs. With our growing Fast Lab Network, we have the potential to rapidly change the pace and possibilities of molecular testing." EUA Status of LumiraDx SARS-CoV-2 RNA STAR Complete About LumiraDx FastLab 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 FastLab Solutions enables laboratories to improve efficiency and reduce time to result. About LumiraDx LumiraDx is based in the UK with more than 1500 employees worldwide. 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 performance and benefits of the re-issued Emergency Use Authorization (EUA) SARS-CoV-2 RNA STAR Complete and expectations regarding the regulatory submission or clearance of additional tests. 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. View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-reissues-lumiradx-fast-lab-solutions-eua-for-sars-cov-2-rna-star-complete-molecular-reagents-to-allow-high-throughput-and-asymptomatic-testing-solutions-301435005.html SOURCE LumiraDx |
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Company Codes: NASDAQ-NMS:LMDX |