As part of its growing portfolio of medical device and healthcare solutions, Team Technologies, Morristown, Tenn, will produce point-of-care (POC) rapid antigen covid-19 tests to assist organizations seeking the benefits of rapid testing for covid-19. Team Technologies is producing the in vitro diagnostic (IVD) test with Maxim Biomedical, Rockville, Md, which developed the test as part of the NIH Rapid Acceleration of Diagnostics RADxSM initiative, a program launched last April to speed innovation in the development, commercialization, and implementation of testing technologies for covid-19. Team Technologies has facilities across the United States providing a variety of services ranging from product development and supply line expertise to packaging and kitting of the SARS-CoV-2 diagnostic tests. “We are pleased to be working with the team at Maxim Biomedical as an instrumental partner in bringing this much needed testing solution to market,” says Marshall White, president and CEO of Team Technologies. Collectively, Team and Maxim currently have a goal to produce 3 million tests by year’s end and to achieve a production rate of 15 million tests per month in early 2021. The SARS-CoV-2 Rapid Antigen Diagnostic Test utilizes 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 achieves this by combining 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 two hours. Complementing the IVD and POC experience of Maxim Biomedical, Team Technologies is employing its medical device manufacturing capabilities to rapidly scale production quantities of the SARS-CoV-2 rapid antigen test. “Many organizations, from schools to businesses to factories, can benefit from having the ability to perform testing that produces safe, quick and easy-to-interpret results,” White adds. “We are proud to partner with our colleagues at Maxim Biomedical to make this test available.” Jonathan Maa, COO of Maxim Biomedical Inc., says, “Maxim Biomedical has always endeavored to provide high-quality testing where it would fulfil unmet needs. The urgent demand for testing is an opportunity to apply our expertise in LFA technology. We developed a point-of-care rapid antigen test that is safe for community use and reduces risk for patients and front-line workers. We are glad we found a partner like Team Technologies to help us bring this important test to market.” As part of an effort to boost covid-19 testing capacity, 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. This SARS-CoV-2 Rapid Antigen Diagnostic Test has not been FDA cleared or approved. For more information, visit Team Technologies and Maxim Biomedical.
NILA Applauds CRL for Launching Saliva-Based Covid-19 Test
August 19, 2020
HHS Launches Pilot Program of Fast Molecular POC Test for Covid-19
November 19, 2020