World's First 15-minute, Instrument-free, Lab-Quality Molecular Test Available Now
Global molecular diagnostics innovator, Sense Biodetection (Sense), announced today that it had entered into a strategic distribution agreement with Cruinn Diagnostics Ltd. (Cruinn) for the Irish market. Cruinn, a leading supplier in the healthcare and laboratory market, is among the network of planned EU distribution partners authorized to market Veros COVID-19. Sense received CE Mark for Veros COVID-19 in early March 2022.
"Cruinn's reputation for customer service and innovative point-of-care products is best in class in its market," commented Ryan Roberts, Chief Commercial Officer of Sense. "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," said Aidan Wearen, head of Marketing and Sales for Cruinn. "Sense's approach to molecular testing delivers great opportunity for accessibility, speed, and clinical value to patients 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. Using a proprietary, rapid molecular 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 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)
- 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
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.
About Sense Biodetection
Sense Biodetection is a global molecular diagnostics company focused on empowering patients and transforming healthcare access and affordability by bringing lab-quality results through easy-to-use, rapid, disposable molecular tests without the constraints of an instrument. The company's Veros product platform will enable widespread testing to enhance patient access, improve patient health and lower systemic healthcare costs. Backed by respected investors, such as Koch Disruptive Technologies, Cambridge Innovation Capital, Earlybird Health and Mercia Asset Management, Sense is growing rapidly as it launches Veros COVID-19 and builds a portfolio of additional tests for other diseases. Sense recently received CE Marking in Europe for Veros COVID-19.
For more information, visit www.sense-bio.com and follow the company on Twitter and LinkedIn.
About Cruinn Diagnostics
Established in 1998 in partnership with some of the leading manufacturers from across the world, Cruinn Diagnostics Limited quickly established itself as one of Ireland's leading distributors of Laboratory supplies and equipment to the Clinical, Industrial, Pharmaceutical, Veterinary, University and Research industries.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220317005055/en/
Contacts:
Media Contact:
Mike Sinclair (for Sense Biodetection)
Halsin Partners
+44 7968 022075
msinclair@halsin.com
