Skip to main content
Premium Trial:

Request an Annual Quote

Sense Biodetection Obtains CE Mark for Rapid, Disposable COVID-19 Molecular Diagnostic

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.

The Scan

Machine Learning Helps ID Molecular Mechanisms of Pancreatic Islet Beta Cell Subtypes in Type 2 Diabetes

The approach helps overcome limitations of previous studies that had investigated the molecular mechanisms of pancreatic islet beta cells, the authors write in their Nature Genetics paper.

Culture-Based Methods, Shotgun Sequencing Reveal Transmission of Bifidobacterium Strains From Mothers to Infants

In a Nature Communications study, culture-based approaches along with shotgun sequencing give a better picture of the microbial strains transmitted from mothers to infants.

Microbial Communities Can Help Trees Adapt to Changing Climates

Tree seedlings that were inoculated with microbes from dry, warm, or cold sites could better survive drought, heat, and cold stress, according to a study in Science.

A Combination of Genetics and Environment Causes Cleft Lip

In a study published in Nature Communications, researchers investigate what combination of genetic and environmental factors come into play to cause cleft lip/palate.