Global molecular diagnostics innovator, Sense Biodetection announced receipt of CE Marking for Veros Covid-19, the first and only fully integrated, easy-to-use molecular diagnostic test that provides laboratory-quality results in 15 minutes. Unconstrained by an instrument or reader and using a patient-friendly anterior nasal swab, Veros Covid-19 was designed for use in near-patient environments, such as hospital emergency departments, pharmacies, care homes, and urgent care, providing accurate results and streamlining clinical decision making. Sense anticipates launching Veros Covid-19 in Europe this quarter, initially in Ireland, Benelux and the Nordic regions.

Analytical performance testing has demonstrated that Veros Covid-19 is over 1,000 times more sensitive than widely used antigen tests. It brings the performance of lab-based PCR tests, which detect approximately 30% more true positives than antigen tests, directly to the point of care. Furthermore, where the performance of some antigen tests has waned with new variants, Veros Covid-19 has maintained 100% conservation in all Variants of Interest and Concern identified to date by WHO and US CDC.

“Obtaining our first regulatory approval is a pivotal milestone for Sense, allowing us to deliver on our founders’ vision in 2014 to empower patients and clinicians with a pioneering new class of diagnostic product. We look forward to making Veros Covid-19 available in many European countries this quarter, followed by other major markets as additional regulatory approvals are obtained.” said Timothy I. Still, Chief Executive Officer of Sense Biodetection. “This is the first step in our ambitious plan to develop a wide range of tests on the Veros platform to transform the treatment of many other infectious diseases, including influenza, respiratory syncytial virus (RSV) and sexually transmitted pathogens.”