ROCKVILLE, Md., Sept. 4, 2020 /PRNewswire/ -- Today, Maxim Biomedical (Maxim), a company dedicated to the development of high quality, in-vitro diagnostic (IVD) and Point-of-Care (POC) testing solutions, announced plans to produce and market as many as 3 million Maxim SARS-CoV-2 Rapid Antigen Diagnostic Tests (patent pending) by the end of the year. The test was developed in conjunction with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADxSM) initiative.
The Maxim SARS-CoV-2 Rapid Antigen Diagnostic Test employs proven Lateral Flow Assay (LFA) technology with a streamlined workflow, and a closed-tube format that eliminates the need for expensive equipment or a reader to perform. The assay combines the specimen swab, reagents, and test strip in a compact self-contained environment, allowing for incubation, reading and disposal in one tube. Results are available within 15 minutes and stable for more than 2 hours, making the test quick and the result reviewable for a longer period than many LFA tests.
In a recent interview, Jonathan Maa, COO of Maxim Biomedical Inc. said, "Maxim Biomedical has always endeavored to provide high quality testing where it would fulfill unmet needs. COVID-19 represents an opportunity to apply our expertise in LFA for application at the point-of-care with an eye to community safety and reducing risk for patients and front-line workers."
According to Mr. Maa, the company is on track to meet their goal of greater than 1 million tests per month by year's end and to achieve their production rate of 15 million tests per month in early 2021. The company is working with TEAM Technologies (Morristown, TN) to expand manufacturing capacity.
Asked about working with Maxim, Marshall White, President and CEO of TEAM Technologies said, "We combined Maxim Biomedical's development expertise and TEAM Technologies' specialty manufacturing capabilities to rapidly scale production quantities of the SARS-CoV-2 rapid antigen test." He went on to say, "TEAM Technologies is proud to partner with the great folks at Maxim Biomedical to bring this test to market."
Maxim has partnered with the U.S. Department of Defense, Emory University, Northwestern University and the University of Massachusetts to independently evaluate the assay's clinical performance.
Dr. Wilbur A. Lam, MD, Ph.D., Associate Professor of Pediatrics and Biomedical Engineering at Emory University School of Medicine led the evaluation of the Maxim SARS-CoV-2 Rapid Antigen Diagnostic Test at Emory. Dr. Lam has high praise for the assay. "Our RADx center evaluated Maxim's technology and our scientists and physicians collectively agreed that this device would be extremely effective. We're especially enthusiastic about the device's simplicity, usability, low cost, and convenience."
This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx SM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00020.
The Maxim SARS-CoV-2 Rapid Antigen Diagnostic Test has not been FDA cleared or approved.
About Maxim Biomedical Inc.
Founded in 2005 as a branch of the Maxim family of businesses, Maxim Biomedical was created as a company dedicated to the development of high quality, in-vitro diagnostic (IVD) and Point-of-Care (POC) testing solutions that make positive contributions to public health and healthcare worldwide. Maxim Biomedical's 26,000 square foot facility houses over 13 individual laboratories. The company offers a line of FDA and CDC approved products, as well as raw materials, and customized CRO/CMO services.
About TEAM Technologies
Headquartered in Morristown, TN with 13 facilities throughout the United States, TEAM Technologies is a leading solutions provider supporting the foremost global healthcare products companies. With its 'ONE TEAM, MANY TECHNOLOGIES' philosophy, TEAM boasts an extensive lineup of manufacturing processes designed to service the oral care, infection prevention and control, advanced wound care, pharmaceutical dispensing, IVD diagnostics and other medical end markets. For more information, visit teamtech.com.
SOURCE Maxim Biomedical, Inc.