LumiraDx Receives FDA Emergency Use Authorization and UK CTDA Approval for its Fast Lab Solutions Multiplex COVID and Influenza Molecular Assay

Rhea-AI Summary

LumiraDx Limited (Nasdaq: LMDX) has received Emergency Use Authorization from the FDA and validation under the UKHSA CTDA process for its LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay. This multiplex test allows for the simultaneous detection of influenza A, influenza B, and SARS-CoV-2 infections within 20 minutes, utilizing innovative qSTAR technology for high-throughput, direct amplification. The assay will soon be commercially available in the U.S. and U.K., following its launch in Europe in June 2022. It aims to enhance respiratory illness diagnostics, providing accurate results from a single sample.

Positive

• FDA Emergency Use Authorization received for LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay.
• Test allows simultaneous detection of influenza A, B, and SARS-CoV-2 in 20 minutes.
• Utilizes innovative qSTAR technology for high throughput and direct amplification.
• Commercialization in U.S. and U.K. to commence imminently.

Negative

• None.

• LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay receives Emergency Use Authorization from the FDA along with being successfully validated by the UK Health Security Agency (UKHSA) under the Coronavirus Test Device Approvals (CTDA) process.
• This multiplex test utilizes the innovative qSTAR technology allowing for high-throughput, direct amplification, with highly sensitive results on open molecular platforms.
• LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay adds to LumiraDx’s expanding portfolio of qSTAR molecular solutions for COVID testing.
  

LONDON, Feb. 06, 2023 (GLOBE NEWSWIRE) -- LumiraDx Limited (Nasdaq: LMDX) today announced that it has received an Emergency Use Authorization from the U.S. Food and Drug Administration and validation for use by the UKHSA under the CTDA process for the LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay that will allow high complexity laboratories to quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. This makes it essential to correctly identify them in order to treat and manage patients accordingly.

The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete multiplex test allows for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 infections within 20 minutes or less. The assay takes advantage of the innovative qSTAR technology which utilizes a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments which will be a powerful diagnostic tool for this respiratory season.

LumiraDx launched the LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay in the European Union and other markets that accept CE-IVD in June 2022 and will now begin commercialization of the test in the U.S. and U.K.

“With the limited number of direct amplification multi-analyte tests available, we believe that this test will become a fundamental tool for the detection and differentiation of SARS-CoV-2 from influenza,” explains Sanjay Malkani, President of the LumiraDx Molecular Diagnostics Business. “As the burden of respiratory illness continues, we look forward to providing our clinical diagnostic lab and reference lab customers with a high-throughput, highly sensitive multiplex test with results available in 20 minutes - and the added benefit of accurately detecting influenza and COVID from a single sample.”

The company plans to commence commercial shipments imminently.

About LumiraDx Fast Lab Solutions

LumiraDx Fast Lab Solutions 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 Limited (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Its actively controlled microfluidic technology provides fast, high performance and accessible diagnostic solutions wherever the patient is for nearly any testing scenario, creating unique testing options at the point of need.

The company offers a broad menu of lab comparable tests on a single portable Platform, with more than 30 assays on the market and in the pipeline, covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders. The company also supports high-complexity laboratory testing in an accessible high-throughput format to leverage current molecular laboratory operations.

Founded in 2014 and based in the UK, LumiraDx's diagnostic testing solutions are being deployed globally by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to help screen, diagnose, and monitor wellness as well as disease. More information on LumiraDx 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 LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay and the timing of commercial launch and shipments of certain products. 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; changes in interest rates, inflation rates and global and domestic market conditions; the effect of COVID on our business and financial results; obtaining or maintaining regulatory approval, authorization or clearance for our tests; and those factors discussed under the header "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission, or SEC, on April 13, 2022, in our report on Form 6-K that was filed with the SEC on August 16, 2022, and in other filings that we make 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.

FAQ

What is the LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay?

It is a multiplex test authorized by the FDA for simultaneous detection of SARS-CoV-2, influenza A, and influenza B, allowing results in under 20 minutes.

When did LumiraDx receive FDA authorization for its new assay?

LumiraDx received Emergency Use Authorization from the FDA on February 6, 2023.

What technology does the LumiraDx assay utilize?

The assay uses innovative qSTAR technology for high-throughput and direct nucleic acid amplification.

Is the LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay available in the U.S.?

Yes, the assay will begin commercialization in the U.S. following its launch in the European Union in June 2022.

What advantages does the LumiraDx assay provide over traditional tests?

The assay offers rapid results in 20 minutes and differentiates between respiratory infections caused by SARS-CoV-2 and influenza.