NEW YORK – Sense Biodetection announced on Tuesday it has obtained the CE mark for its rapid, disposable COVID-19 molecular diagnostic test called Veros. The firm anticipates an initial launch in Q1 in Ireland, and the Benelux and Nordic regions.
The Veros COVID-19 test uses nasal swabs and a proprietary enzymatic nucleic acid amplification chemistry to provide instrument-free results in 15 minutes. It was designed for use in near-patient environments, such as hospital emergency departments, pharmacies, care homes, and urgent care centers, the firm said in a statement.
"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," Sense Biodetection CEO Timothy Still said in a statement.
A prospective multicenter study with approximately 300 subjects was performed during the Delta and Omicron surges, Sense said, to evaluate the system in near-patient and point-of-care environments with test operators who had no formal lab training or experience. Compared to a US Food and Drug Administration Emergency Use Authorized RT-qPCR assay, Veros demonstrated 95 percent sensitivity and nearly 100 percent specificity.
Dan Delaney, VP of clinical and regulatory operations at Sense, said the clinical performance validated the firm's "high expectations" for its proprietary molecular amplification technology, particularly because the data was obtained from two significant variants of concern.
Sense is based in Oxford and Cambridge, UK, as well as in Boston and is backed by investors such as Koch Disruptive Technologies, Cambridge Innovation Capital, Earlybird Health, and Mercia Asset Management.
The firm intends to develop a range of tests on the Veros platform for infectious diseases such as influenza, respiratory syncytial virus, and sexually transmitted pathogens.