MaximBio designed, tested and will manufacture ClearDetect™ in the United States to help meet the growing demand for home testing
Press Release published by PR Newswire
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 in the home and at the point-of-care with an accurate and easy-to-use solution.” Mr. Maa said that the ClearDetect™ COVID-19 Antigen Home Test is just the first of a series of at-home diagnostics MaximBio has in the works.
The test will be available in two kit configurations—packaged two (2) tests in a box for convenient at-home use, and in a bulk 25-test pack amenable for healthcare settings, schools, workplaces, and other high-volume testing scenarios. MaximBio expects both configurations to be competitively priced and affordable. According to Mr. Maa, the company is poised for immediate production ramp up in anticipation of a late February/early March launch.
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. It is intended for use only under the Food and Drug Administration’s Emergency Use Authorization.
About Maxim Biomedical, Inc.
Headquartered in Rockville, MD, Maxim Biomedical is a leading diagnostic healthcare company providing innovative solutions through the development and manufacture of trusted testing solutions. Our mission is to create diagnostic products that are affordable, accessible, and enable actionable testing to improve patient outcomes around the globe. For more information, visit maximbio.com