Maryland Company Poised to Produce Millions of Point-of-Care COVID-19 Tests that Deliver Accurate Results in 15 Minutes
Rockville, Maryland’s Maxim Biomedical (MaximBio) is on the cusp of bringing 3 million of its new and effective point-of-care COVID-19 tests to the fight against the coronavirus pandemic in early 2021, with a scale up to 15 million tests per month expected by Q2 2021.
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.
MaximBio is a family-owned business that was founded in 2005; it is part of the Maxim family of businesses. The company operates out of its 26,000 square foot fully FDA-registered, cGMP compliant, and ISO13485 certified facility in Rockville that houses 13 labs. MaximBio offers a suite of FDA and CDC approved products, as well as customizable CDMO services.
“We develop and commercialize our own in-house products like our SARS-CoV-2 test and we can help our customers take a concept, develop it, validate it, and take it to market. Quality is a huge priority for us at MaximBio. We are very proud of the quality systems that ensure we only deliver the highest level products,” stated Jonathan Maa, MaximBio’s Chief Operating Officer (COO), and the company’s lead on COVID-19 initiatives.
“We’re really excited about getting our rapid antigen test to the market,” he added.
The company’s deep experience in the diagnostic development space and as a CDMO partner enabled the company to pivot quickly to developing SARS-CoV-2 diagnostic testing. In addition, MaximBio’s partnership with the NIH through its Rapid Acceleration of Diagnostics (RADxSM) program has helped the company accelerate the development and production of its rapid antigen test.
“Our rapid antigen test is a highly sensitive product that is visually interpreted, which is a big advantage. Expensive equipment is not required to use our assay. Everything you need is right in the box. We’ve developed a closed tube design where everything—the reagents, the sample swab, and the test strip—is enclosed in a single tube…This reduces the risk of exposure and avoids spillage when the test is being used,” stated Maa.
The SARS-CoV-2 rapid antigen test is easy to use, with results in 15 minutes or less. There are several unique aspects to MaximBio’s new test.
First, the sample swab’s handle can be broken off, leaving the swab within the tube for the entire process, significantly reducing the risk of contamination. Second, the test can be visually interpreted; a test strip is dropped into the tube and if two lines appear, the test is positive. This allows the test to truly operate as a POC diagnostic, in that complex test readers and other expensive equipment are not required to interpret results. The test can be administered and easily and inexpensively read.
“There is a higher level for accessibility for some of the other available assays. Readers are not cheap and there are some supply chain limitations for getting them. There are also limitations on who can actually administer the test. For example, some readers can only be used in CLIA lab environments,” shared Maa. “Our test is a true POC diagnostic.”
“The goal of our test is to increase accessibility to as many locations as possible. We want to enable testing in low resource environments. There are many use cases for our test, but one market we are interested in is universities that need to test their students but don’t have labs,” he added. “Our test is designed to be administered by a clinician and someone trained to use the test, so schools are a good fit.”
Scaling up test production has been a challenge that MaximBio has handled with aplomb.
“Due to the COVID-19 need, you just have to move fast. The NIH’s support has allowed us to scale up smoothly. The first thing we had to do was set up production lines that can handle this volume and so we can make as many tests as possible as fast as we can,” shared Maa.
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.
“We started manufacturing tests in house and have developed partnerships to increase capacity. It’s been amazing to see how the diagnostics community has come together. Historically, we have been the CDMO people have come to and now we are operating on the other side,” he added.
“Having more frequent and rapid testing is an important part of getting control of the pandemic. With POC rapid tests that are easily read, we can test on a more widespread scale, which will help contain the virus more effectively,” stated Maa. “We are a small company, but we are nimble. We have a family culture here at MaximBio and we’re proud to have contributed to the fight against COVID-19.”
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.
With COVID-19 numbers spiking across the globe, MaximBio’s promising new rapid antigen test is more welcome good news to add to the recent Pfizer and Moderna announcements about the 95% effectiveness of their respective vaccine candidates.
There seems to be more and more light at the end of the COVID-19 tunnel.
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