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Cue Health has received a $28m federal contract for the development of Flu A/B, RSV and Covid-19 molecular multiplex tests for both point-of-care (POC) and over-the-counter applications.
The contract has been awarded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services.
The test is being developed to identify and distinguish the four viruses, delivering results in approximately 25 minutes.
Cue Health has also submitted an application to the US Food and Drug Administration (FDA), seeking emergency use authorisation (EUA) for its Cue Flu + COVID-19 Molecular Test.
Additionally, the company has applied to the FDA for the De Novo classification of the Cue RSV Molecular Test, seeking authorisation.
In March this year, the corporation secured EUA from the FDA for the Cue Mpox (Monkeypox) Molecular Test, which can be used at POC at any CLIA-waived facility.
Cue Health chairman and CEO Ayub Khattak said: “We expect this test will arm individuals and their providers with actionable information that can reduce community spread, increase the efficacy of treatment and help lead to better health outcomes.”
In 2020, Cue secured a contract from BARDA to boost the development, validation and FDA approval of its Covid-19 test.
It is claimed to be the first molecular test to obtain FDA EUA for over-the-counter and at-home use without a prescription.
Recently, the corporation secured De Novo authorisation from the FDA for the same Covid-19 test called the Cue Covid-19 Molecular Test. All molecular tests of the company run on the Cue Health Monitoring System.
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- Source: https://www.medicaldevice-network.com/news/cue-health-contract-multiplex-test-development/
