Sense Biodetection (Sense), today 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.”
Veros COVID-19’s clinical performance was established in one of the most comprehensive clinical trials in COVID-19 diagnostic testing conducted to date. The multicentre study prospectively enrolled nearly 300 evaluable subjects during both the Delta and Omicron variant surges of the pandemic. All study sites represented near-patient testing / point-of-care environments, with all test operators reporting no prior formal laboratory training or experience.
Veros COVID-19 results were compared directly against a highly-sensitive, CE Marked and WHO & US FDA emergency authorized qRT-PCR test, from a world-leading developer and manufacturer of laboratory diagnostics. In just 15 minutes, the Veros COVID-19 delivered:
- 97.9% Accuracy (286/292),
- 95.2% Sensitivity (99/104); and
- 99.5% Specificity (187/188).
- 100% of operators agreed the Veros COVID-19 was easy-to-use, read and understand the results, with minimal hands-on time required from start to finish.
“Veros COVID-19’s clinical performance validated our high expectations for our proprietary molecular amplification technology, particularly because the data were obtained from two significant Variants of Concern – roughly half of our positives came from each of the Delta and Omicron waves,” said Dan Delaney, VP of Clinical & Regulatory Operations. “We look forward to generating additional evidence demonstrating Veros COVID-19’s ability to empower providers and their patients with accurate, reliable and trustworthy molecular results in 15 minutes, right at the point of care.”
Unconstrained by an instrument or reader, the Veros platform has the potential to improve access to rapid, highly accurate, point-of-care testing for many more people, which may lead to more precise diagnoses and improved speed to clinical decision making. Veros produces billions of copies of the target genetic material and delivers easy to read, instrument-free, laboratory-quality results directly to users within minutes. See how it works here.
For in vitro diagnostic use only.
Veros COVID-19 is intended for the detection of SARS-CoV-2 RNA in nasal samples from symptomatic patients suspected of COVID-19 infection by qualified healthcare professionals, in near-patient settings.
Before performing a test, please refer to the Instructions for Use.