Cue Health Inc. (“Cue Health” or “Cue”), a healthcare technology company, today announced it has received regulatory approval from The Central Drugs Standard Control Organisation (CDSCO) for the Cue COVID-19 Test for professional point-of-care use in India. Internationally, Cue has also received the CE mark in the European Union (EU), as well as Interim Order authorization from Health Canada.
In the U.S., the Cue Health Monitoring System, together with the Cue COVID-19 Test Kit, has been authorized both for point-of-care use by providers as well as for over-the-counter use by consumers. Cue was the first-ever U.S. Food and Drug Administration (FDA) Emergency Use Authorized molecular-based diagnostic test for home use without a prescription. Cue is being used by the National Basketball Association (NBA) and the Mayo Clinic, in addition to a range of other clinical and point-of-care settings, including essential businesses, schools, nursing homes, hospitals, physicians’ offices, dental clinics, professional sports leagues, live event venues, hotels, federal and state agencies, and other settings around the country.
“There is an urgent, global demand for real-time, actionable, and connected health data and we plan to fill that unmet need around the world. Now, with this authorization, we can make a positive impact in India, just as we have been able to do in the United States,” said Ayub Khattak, co-founder and CEO of Cue. “By making diagnostic testing accessible, fast, accurate and easy to use, we can facilitate faster and better-informed decision making.”
Cue’s easy-to-use, portable COVID-19 test provides highly accurate, lab-quality results – including detection of emerging variants – directly to connected mobile smart devices in about 20 minutes, and Cue’s natively digital platform allows for end-to-end integrated reporting of test results.
Cue expects to enable end-to-end care journeys from diagnostic tests to physician consultation via telemedicine through intervention. The Cue Health Monitoring System is designed to deliver a broad menu of tests through one system. Cue plans to develop a suite of offerings to address respiratory health, sexual health, cardiac and metabolic health, women’s health, men’s health, and chronic disease management by connecting diagnostics with telemedicine.