Maxim Biomedical has revealed the plans to manufacture and market three million Maxim SARS-CoV-2 Rapid Antigen Diagnostic Tests for the diagnosis of Covid-19 by the end of the year.
The test uses Lateral Flow Assay (LFA) technology with a streamlined workflow and a closed-tube format to avoid the need for a reader or expensive equipment to perform.
The patent-pending assay consists of specimen swab, reagents and test strip in a compact self-contained environment, which enables incubation, reading and disposal in a single tube.
Furthermore, the test is designed to offer results within 15 minutes and results can be reviewed for a period of two hours, which is longer than what most LFA tests offer.
In a recent interview, Maxim Biomedical COO Jonathan Maa said: “Maxim Biomedical has always endeavoured to provide high-quality testing where it would fulfil 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 frontline workers.”
Maxim SARS-CoV-2 Rapid Antigen Diagnostic Test was developed by Maxim Biomedical as part of Rapid Acceleration of Diagnostics (RADxSM) initiative, in conjunction with the National Institutes of Health (NIH).
The company expects to produce over one million tests per month by the end of the year and scale up the production rate to 15 million tests per month at the beginning of next year.
Currently, the company is collaborating with TEAM Technologies to expand its manufacturing capacity.
TEAM Technologies president and CEO Marshall White said: “We combined Maxim Biomedical’s development expertise and TEAM Technologies’ speciality manufacturing capabilities to rapidly scale production quantities of the SARS-CoV-2 rapid antigen test.”
Maxim is also working with the US Department of Defense, Emory University, Northwestern University and the University of Massachusetts to independently assess the clinical performance of the assay.
The Maxim SARS-CoV-2 Rapid Antigen Diagnostic Test has not been the Food and Drug Administration (FDA)-cleared or approved.