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Maryland Company Poised to Produce Millions of Point-of-Care COVID-19 Tests that Deliver Accurate Results in 15 minutes

November 25th, 2020

 

The company's brand new point-of-care (POC), ready out-of-the-box antigen test is based on a Lateral Flow Assay technology (LFA) that produces visually interpreted results within 15 minutes.

 

As part of this herculean effort, MaximBio has built out its test production and distribution network to include TEAM Technologies and other partners that will eventually bring millions of MaximBio's rapid tests to the market.

Although the test has not yet received Food and Drug Administration (FDA) approval, MaximBio is confident that it will be able to produce 3 million tests per month early in 2021 with significant scale up of production to 15 million tests per month in Q2 2021.

360Dx - Maxim Biomedical Ramps Up Manufacturing, Completes Validation of 15-Minute SARS-CoV-2 Antigen Test

October 19th, 2020

 

To gain acceptance in the market, the company has eliminated the use of an instrument and designed an assay with user safety and convenience in mind. Maxim Biomedical's test strip uses proprietary detection nanoparticles conjugated to antibodies that target the SARS-CoV-2 nucleocapsid protein in a nasal swab sample to ascertain whether the test is positive or negative. The design enables a healthcare worker to take a nasal swab from a patient, insert the swab in the test tube that contains a reagent, and then break the swab so that the tube can be closed. Prior to closing the tube, the test strip is also inserted.

Maxim Biomedical was recently awarded an undisclosed amount of funding to further develop and validate its test through the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) initiative, which aims to support the commercialization of new tests and bring technologies to market within six months that would normally take years to develop and launch.

Maxim Biomedical Inc. Rapid Antigen COVID-19 (SARS-CoV-2) Test to Deliver Results in Less Than 15 Minutes While Reducing Risk of Exposure to Healthcare Workers

September 4th, 2020

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.

The National Institutes of Health Award Maxim Biomedical Millions in Manufacturing and Scale Up Support for MaximBio SARS-CoV-2 Rapid Antigen Test

September 2nd, 2020

The National Institutes of Health today announced $129.3 million in scale-up and manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. NIH is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can return results within 24 hours. These tests add to initial awards made to seven companies on July 31, 2020.

“The opportunity to scale up high-throughput laboratories and rapid point-of-care tests to meet the needs of communities all around the country is critical,” said Rick A. Bright, Ph.D., senior advisor to the NIH director and lead for the RADx-Advanced Technology Platforms program. “The RADx initiative reflects the scientific ingenuity, technical diversity and logistical capabilities of the private sector at its finest.”

Siemens and partners remove barriers, scramble to help protect Americans

In the United States, the first case of COVID-19, caused by the SARS-CoV-2 virus, was discovered on January 21 - by the end of May there were over 1.8 million cases and more than 100,000 had died. So, Juan Aparicio and his research team at Siemens Technology got word in June that the Advanced Robotics for Manufacturing (ARM) Institute was looking for robotic and automated solutions to increase the speed and scale at which the United States can diagnose COVID-19, they knew they had to work fast.

Six short weeks later, in "record time," they wrote a winning proposal and signed, sealed and delivered the contracts needed for ARM's choice of partners - Siemens Technology, Maxim Biomedical and Siemens Healthineers - to get started.

The partners are automating the test strip evaluation in Lateral Assay (LFA) tests - like those used in pregnancy tests women take at home - so the U.S. can reach the scale needed for effective management and control of things like coronavirus.

Throughout the next 11 months, Siemens Healthineers and Siemens Technology will transfer technology as it matures to Maxim Biomedical.