MaximBio’s ClearDetect Covid-19 antigen home test was cleared for in vitro diagnostic use by the US Food and Drug Administration’s (FDA) emergency use authorisation in 2022. Image Credit: MaximBio.

The US Department of Health and Human Services (HHS) has awarded $49.5m to Maryland-based MaximBio to fortify its manufacturing capabilities for diagnostic tests.

The funding was awarded through the US Administration for Strategic Preparedness and Response (ASPR) and is part of a broader initiative by the Biden-Harris administration.

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The Biden-Harris initiative included the disbursement of a $600m grant across 12 US-based Covid-19 test manufacturers. In addition, the HHS reopened COVIDTests.gov to deliver Covid-19 tests for free to households across the US.

MaximBio’s ClearDetect Covid-19 antigen home test was developed using grants from the US Department of Defense (DoD) and the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADx) initiative. The test detects Covid-19-specific antigens in the nasal swab.

MaximBio’s ClearDetect test was cleared for in vitro diagnostic use by the US Food and Drug Administration’s (FDA) emergency use authorisation in 2022. In September 2023, MaximBio updated the ClearDetect tests to increase the test’s shelf-life expiration date to 24 months, when stored at 4°C-30°C.

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There has been a renewed interest in Covid-19 diagnostics and treatment in light of new Omicron subvariants. The Covid-19 in vitro diagnostic market is forecasted to be worth approximately $3bn in 2030, as per GlobalData’s market model.

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In November 2023, US-based ACON Laboratories received 510(k) marketing clearance from the FDA for its Flowflex Covid-19 antigen home test. The over-the-counter rapid antigen test can detect the new Covid-19 variant.

Last June, Cue Health also received de novo authorisation from the FDA for its Covid-19 at-home test, the Cue Covid-19 molecular test. The molecular nucleic acid amplification test can detect the SARS-CoV-2 virus and can be used in both point-of-care and at-home settings.

Other recipients of the $600m US HHS grant included California-based iHealth Lab, which received $167m for its iHealth Covid-19 antigen rapid test. New Jersey-based Access Bio and California-based CorDx received $88.7m and 86.4m respectively for their lateral flow immunoassays, CorDx Covid-19 Ag test and CareStart Covid-19 antigen home test.