Newswise — LumiraDx, a next-generation point of care diagnostics company will be hosting an industry workshop at this week’s American Association for Clinical Chemistry (AACC) Annual Conference in Chicago. The workshop, held on July 27th, will include data-backed insights on the impact of LumiraDx’s advanced microfluidic technology over lateral flow point-of-care antigen tests, and the role of these rapid immunoassays in response to the COVID-19 pandemic.
Speaking during the session will be lead author on a number of research papers(1,2) reviewing the SARS-CoV-2 Ag test, Paul Drain, MD, MPH, FIDSA, Associate Professor in the Departments of Global Health, Medicine (Infectious Diseases), and Epidemiology at the University of Washington, along with Brian DuChateau, Ph.D., D(ABMLI), VP of Clinical and Scientific Affairs, LumiraDx.
Key findings in the study revealed that the LumiraDx SARS-CoV-2 Ag test showed a 97.6% positive agreement to RT PCR in patients up to 12 days following symptom onset, and 100% PPA up to Ct 33.(1)
Dr. DuChateau commented, “Studies have shown that point of care antigen tests with sufficient sensitivity and specificity can facilitate diagnosis, treatment, and mitigate reliance on slower, conventional laboratory-based testing and infrastructure.” He continued, “However, the COVID-19 pandemic not only demonstrated the need for this type of testing, but also showed how quick result turn-around-time can mitigate rates of infection. LumiraDx’s actively controlled microfluidic testing technology brings lab-comparable performance to the point-of-need, supporting several unique use-cases during the pandemic and beyond.”
The workshop, ‘Clinical Performance of the LumiraDx Platform and Intended Applications’, will be held on Wednesday, July 27th from 2:45- 3:45 at the Exhibit Hall Theater 3 in the McCormick Place Convention Center Chicago.
In addition to hosting the workshop, LumiraDx will be exhibiting in the show’s main exhibition hall at booth #4821, and will be presenting its poster abstract ‘Correlation of the Rapid, Point-of-Care LumiraDx SARS-CoV-2 Antibody Test to Other SARS-CoV-2 Antibody Tests and to Viral Neutralization’ (poster B-195) and be featured in a poster abstract by John’s Hopkins Hospital ‘Implementation of POCT COVID-19 Testing Using a LumiraDx SARS-CoV-2 Testing Platform in Patient and Employee Testing Environments’ (poster A-142.)
More information on the workshop and annual conference may be found here.
References
1. A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study, Infectious Diseases and Therapy 2021
2. Rapid Diagnostic Testing for SARS-CoV-2, NEJM, 2022
About the LumiraDx SARS-CoV-2 Antigen Test
The LumiraDx SARS-CoV-2 Antigen test has not been FDA cleared or approved, but has been authorized by the FDA under an EUA for use by authorized laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of the product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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
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.
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 SARS-CoV-2 Ag test. 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 and those factors discussed under the header "Risk Factors" in the Annual Report on Form 20-F for the year ended December 31, 2021, which was filed by LumiraDx with the Securities and Exchange Commission ("SEC") on April 13, 2022, and other filings made by LumiraDx 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.
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