MaximBio Wins EUA for At-Home COVID-19 Test
While COVID-19 infections rates are on a downturn, the viral threat is expected to become an endemic concern, which means at-home testing will remain a booming sector in the industry. With its newly authorized at-home antigen test, Rockville’s MaximBio expects to carve out a significant share of the market.
At the end of January, the U.S. Food and Drug Administration granted Emergency Use Authorization to MaximBio’s ClearDetect COVID-19 Antigen Home Test, which has been designed to be as user-friendly as possible. MaximBio Chief Operating Officer Jonathan Maa believes that the company’s ClearDetect test will differentiate itself from other tests on the market due to its simplicity and the strength of the company’s proven Lateral Flow Assay (LFA) technology. In an interview with BioBuzz, Maa said at-home testing is an urgent need in the United States and that need “will exist for some time.”
“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,” Maa said.
The ClearDetect test consists of only three parts, a swab, a test strip, and a test tube pre-filled with sample buffer. Maa explains that the simplicity of the setup benefits patients because they do not need to measure out reagents or handle dropper bottles as some other at-home tests require. Once the swab is taken and deposited in the tube, results are available within 15 minutes. What’s more, the results of the test will remain visible for up to 30 minutes, which allows plenty of time for an individual to capture the results of their test.
With COVID-19 expected to become an endemic concern, meaning a virus that is always circulating within the population, the at-home testing market is expected to grow to $7.6 billion by the end of 2028, a compound annual growth rate of 5.4%. MaximBio expects its new at-home test will meet the growing demand, Maa said.
At-home tests are a desirable commodity as it provides a diagnostic result for a possible infection without having additional exposure risks or potentially spreading the infection to others at a doctor’s office or testing center. At-home antigen tests work on a fairly simple principle. The nasal passage is typically the point of infection in most people—when swabbed and tested, proteins that are on the surface of the SARS-CoV-2 virus are detected if an infection is present.
In testing, the ClearDetect test performed well when it was compared to a PCR test that had previously been authorized by the U.S. Food and Drug Administration under Emergency Use Authorization. In that study, the ClearDetect achieved an 86.9% Positive Agreement (PPA) and 98.9% Negative Agreement (NPA). That makes the test one of the most sensitive and specific antigen tests to receive EUA from the FDA, Maa said.
Additionally, Maa said that the ClearDetect test was also assessed by the National Institutes of Health for its ability to detect the Omicron variant. In that test, the MaximBio detected 100% of live virus Omicron samples diluted to a PCR count value of 25.8. Additionally, ClearDetect detected the Omicron variant at a higher dilution than two other EUA-approved antigen tests.
With the recently garnered authorization, Maa said MaximBio will ramp up manufacturing in order to meet expected demands. Peak manufacturing is expected to be about 12 million units per month, Maa said. The company will accomplish that through a combination of in-house manufacturing and contracting with a third party manufacturing organization.
The test will be available in two kit configurations, two tests per box. It will also be available in a bulk 25-test pack which is convenient for healthcare settings, schools, workplaces, and other high-volume testing scenarios, according to the company. Pricing has not been formally announced but the company said the cost will be “competitive and affordable.” Rollout is expected to begin in late March or early April, Maa said.
When it comes to distribution, MaximBio will rely on a newly-struck deal with Thomas Scientific. When the deal was struck last month, MaximBio Chief Commercial Officer Anthony Morrison touted the partnership. In a brief statement, Morrison said Thomas Scientific’s “dedication to provide the best products with personal, efficient service makes them an ideal partner for MaximBio as we team up to help meet the growing demand for COVID-19 testing.”