On January 19, 2022 , Maxim Biomedical (MaximBio) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for their new ClearDetect™ COVID-19 Antigen Home Test ( ClearDetect™ ).
| ROCKVILLE, Md., Jan. 25, 2022 /PRNewswire/ -- On January 19, 2022, Maxim Biomedical (MaximBio) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for their new ClearDetect™ COVID-19 Antigen Home Test (ClearDetect™). The at-home diagnostics market is growing rapidly and is expected to value over USD 7.6 billion and register a CAGR of over 5.4% by the end of 2028. MaximBio designed, tested, and will manufacture their new assay in the United States to help meet this growing demand for home testing.
The ClearDetect™ COVID-19 Antigen Home Test employs proven Lateral Flow Assay (LFA) technology with a simplified workflow that can easily be done at home without the need for equipment or a reader. The test’s unique format involves only 3 components—a swab, a test strip, and a test tube pre-filled with sample buffer. This eliminates reagent measuring or the need to handle dropper bottles as required with other card-based and self-test systems. To perform a test, a self-collected nasal swab is mixed with the sample buffer in the tube and the swab handle is snapped off. A test strip is added, and the tube is capped for incubation, reading and safe disposal in one tube. Results are available within 15 minutes and the signal lines can be visualized for up to 1 hour, making the test quick and the result reviewable for a longer period than many LFA tests.
The ClearDetect™ COVID-19 Antigen Home Test performed well, when compared to an EUA-authorized PCR method, achieving 86.9% Positive Agreement (PPA) and 98.9% Negative Agreement (NPA), making it one of the more sensitive and specific antigen tests receiving EUA. The test also performed favorably when evaluated by the NIH with specimens positive for the Omicron variant, detecting 100% of live virus Omicron samples diluted to a PCR Ct value of 25.8. In the same study, ClearDetect™ detected the Omicron variant at a higher dilution than two other EUA-approved antigen 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 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
SOURCE Maxim Biomedical, Inc. |
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