Molecular diagnostics innovator, Sense Biodetection, has entered into a strategic distribution agreement with Cruinn Diagnostics for the Irish market.
Cruinn, a supplier in the healthcare and laboratory market, is among the network of planned EU distribution partners authorised to market Veros COVID-19. Sense received CE Mark for Veros COVID-19 in early March 2022.
Ryan Roberts, chief commercial officer of Sense, said: “Cruinn’s reputation for customer service and innovative point-of-care products is best in class in its market. With Veros COVID-19 in its diagnostic portfolio, Cruinn can now offer customers a rapid, self-contained single-use molecular test that offers laboratory-quality results and can enable improved access and faster diagnosis than a lab-based test, helping to provide exceptional care for patients.
“This will be the first instrument-free molecular test for COVID-19 to enter the Irish market, highlighting the strategic importance of this agreement to Cruinn. Sense’s approach to molecular testing delivers great opportunity for accessibility, speed, and clinical value to patients at the point of care.”
The Veros platform has the potential to improve access to rapid, point-of-care testing which may lead to more precise diagnoses and improved speed to clinical decision making. Using an amplification technology, Veros COVID-19 delivers instrument-free, lab-quality molecular results directly to users within minutes.
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 authorised qRT-PCR test, from a world-leading developer and manufacturer of laboratory diagnostics. In just 15 minutes, the Veros COVID-19 delivered:
o 97.9% Accuracy (286/292)
o 95.2% Sensitivity (99/104)
o 99.5% Specificity (187/188)
o 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.
