FDA Reissues LumiraDx Fast Lab Solutions’ EUA for SARS CoV-2 RNA STAR Complete Molecular Reagents to Allow High Throughput and Asymptomatic Testing Solutions
December 1, 2021 (London) : 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
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 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.
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 1500 employees worldwide.
Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com
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.