Cue Health, a healthcare technology company, has received De Novo authorization from the U.S. Food and Drug Administration (FDA) for its Cue COVID-19 Molecular Test. This authorization affirms the test’s compliance with the FDA’s rigorous standards for safety and efficacy. Previously available under an Emergency Use Authorization, the Cue COVID-19 test provides results within 20 minutes and can be connected to mobile smart devices. With an overall accuracy rate of 98%, the test detects all known variants of concern and integrates into Cue Care, the company’s comprehensive test-to-treatment service.
Cue Health’s Chairman and CEO, Ayub Khattak, expressed gratitude for the FDA’s landmark authorization, highlighting the test’s reliability and accuracy in home and point-of-care settings. Khattak emphasized the company’s commitment to enabling faster and more informed healthcare decisions while enhancing convenience in care and treatment. Cue Health’s integrated platform also includes the recently authorized molecular mpox test, as well as other molecular tests currently under FDA review or in clinical studies.
Founded in 2010, Cue Health leverages diagnostic-enabled care to empower individuals in managing their health. The company’s platform offers personalized access to lab-quality diagnostic tests at home and point-of-care, along with telehealth consultations and treatment options. In addition to serving individual consumers, Cue Health collaborates with public sector agencies, healthcare providers, and enterprises. With over 100 patents, the company is headquartered in San Diego and has received FDA authorization for various diagnostic tests, including the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription. Cue Health’s future plans involve expanding its diagnostic test menu and advancing its innovative healthcare solutions.
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