Sense Biodetection has obtained CE Mark for its new molecular diagnostic test, Veros Covid-19.
The new test provides accurate, instrument-free, laboratory-quality results in 15 minutes using patient-friendly anterior nasal swabs.
It is fully portable, disposable, self-contained and easy to use, without any need for an external power supply or additional reader.
Claimed to be the first and only fully integrated molecular diagnostic test, Veros Covid-19 has been designed to be used in near-patient environments, such as pharmacies, care homes, hospital emergency departments and urgent care centres.
The company stated that the test demonstrated 95.2% sensitivity, 97.9% accuracy and 99.5% specificity in a multicentre trial that enrolled approximately 300 subjects during the Delta and Omicron surges.
Results obtained from the Veros Covid-19 test were compared to a CE Marked and WHO and US Food and Drug Administration Emergency Use Authorized qRT-PCR assay.
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The company expects to initially launch the test in Ireland, as well as the Benelux and Nordic regions of Europe.
Sense Biodetection CEO Timothy Still said: “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.
“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.”
Last month, Sense Biodetection signed a distribution agreement with Una Health for the Veros Covid-19 Test in the UK.