The US Division of Well being and Human Providers (HHS) has awarded $49.5m to Maryland-based MaximBio to fortify its manufacturing capabilities for diagnostic checks.
The funding was awarded by way of the US Administration for Strategic Preparedness and Response (ASPR) and is a part of a broader initiative by the Biden-Harris administration.
The Biden-Harris initiative included the disbursement of a $600m grant throughout 12 US-based Covid-19 check producers. As well as, the HHS reopened COVIDTests.gov to ship Covid-19 checks free of charge to households throughout the US.
MaximBio’s ClearDetect Covid-19 antigen house check was developed using grants from the US Division of Protection (DoD) and the Nationwide Institutes of Well being (NIH) by way of the Speedy Acceleration of Diagnostics (RADx) initiative. The check detects Covid-19-specific antigens within the nasal swab.
MaximBio’s ClearDetect test was cleared for in vitro diagnostic use by the US Meals and Drug Administration’s (FDA) emergency use authorisation in 2022. In September 2023, MaximBio up to date the ClearDetect checks to extend the check’s shelf-life expiration date to 24 months, when saved at 4°C-30°C.
There was a renewed interest in Covid-19 diagnostics and remedy in mild of latest Omicron subvariants. The Covid-19 in vitro diagnostic market is forecasted to be price roughly $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 house check. The over-the-counter fast antigen check can detect the brand new Covid-19 variant.
Final June, Cue Health additionally acquired de novo authorisation from the FDA for its Covid-19 at-home check, the Cue Covid-19 molecular check. The molecular nucleic acid amplification check can detect the SARS-CoV-2 virus and can be utilized in each point-of-care and at-home settings.
Different recipients of the $600m US HHS grant included California-based iHealth Lab, which acquired $167m for its iHealth Covid-19 antigen fast check. New Jersey-based Entry Bio and California-based CorDx acquired $88.7m and 86.4m respectively for his or her lateral stream immunoassays, CorDx Covid-19 Ag check and CareStart Covid-19 antigen home test.