– The CE Mark for the Alveo be.well COVID-19 Flex Test is Alveo’s first regulatory approval
– Alveo plans to submit the test for approval by the U.S. Food and Drug Administration under emergency use authorization
Alameda, CA – 02/10/21 – Alveo Technologies, Inc. (Alveo) announced today that it has received its first regulatory approval with the CE (Conformité Européenne) Mark for its be.well COVID-19 Flex Test. The be.well platform is a molecular test based on an isothermal nucleic acid amplification process, and has a real-time healthcare data application program to help accelerate time to COVID-19 treatment and surveillance.
“Alveo is pleased to have CE Mark registration and to have the be.well platform contribute to the public health need for high quality testing related to COVID-19,” said Ron Chiarello, Ph.D., CEO, Founder, and Chairman for Alveo. “This is a first step to deliver our product platform with real-time results and life-saving diagnostic information to everyone, anytime, everywhere.”
The Alveo be.well COVID-19 Flex Test will soon be made available in the UK and European markets. Alveo is also developing other tests as part of the be.well platform to help decentralize diagnostics and for use in any setting providing greater impact and access to healthcare data.
Alveo is leading the transformation of the consumer health tech market with a low-cost, easy-to-use, at-home diagnostic platform that will change the way infectious diseases are detected and managed. The company’s be.well™ testing system gives individuals access to cutting-edge molecular testing and cloud-based data analytics for rapid diagnosis and management of infectious diseases. With an initial focus on acute respiratory infections, including COVID-19, Influenza A/B and RSV, Alveo’s agile and dynamic diagnostic platform can be adapted to detect a wide range of diseases that threaten public health. Affordable access to real-time, at-home results will transform the way individuals, healthcare providers and public health professionals identify and manage disease outbreaks. With be.well™, we will know sooner, act faster and make better-informed decisions toward personalized intervention options that benefit individuals and the entire population.
To learn more, visit https://alveotechnologies.com/
Marketing & Media Coordinator