Sense Biodetection (Sense), is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform.

The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets.

Using rapid molecular amplification technology, the instrument-free test uses a nasal swab sample to give users results within 15 minutes. According to Oxford, U.K.-based Sense, the test demonstrated 95.2% sensitivity, 97.9% accuracy and 99.5% specificity in a multicenter trial that enrolled approximately 300 subjects during the delta and omicron surges.

Sense CEO Timothy Still said its speed, quality and convenience differentiated it from other point-of-care technologies. “When you look at testing, there’s not really been any breakthroughs in bringing molecular diagnostics to point of care settings. It’s always been a very technical type of technology that’s been run in a central lab,” he told BioWorld.

“Until recently there hasn’t been a way to get that same level of performance in a point of care format and definitely not in a disposable format. What Sense is doing is bringing testing in a disposable format to the patient so they can not only be tested in clinics but ultimately at home.”

The CE mark is the first regulatory approval for Sense Biodetection. In addition to targeting Germany, Spain and Italy, the company is applying for Coronavirus Test Device Approval, which will permit a test launch in the U.K. A partnership agreement with U.K. distributor Una Health Ltd. has already been signed.

“Una is an ideal commercial partner because of its exceptional experience in launching new products and creating opportunities for improved patient care,” said Sense chief commercial officer Ryan Roberts. “Una’s strong relationships with customers in the point-of-care segment will be well served by the benefits that our rapid Veros Covid test can bring to the health care delivery process, providing the confidence of lab quality results wherever they are needed.”

Beyond COVID-19
The European launch could pave the way for Sense to launch tests in the influenza, respiratory syncytial virus and sexually transmitted disease markets. Still said the company is scaling the technology to address a variety of viral and bacterial pathogens.

“Our R&D team continues to make progress with additional products, and we hope by the end of 2022 to be out in clinical trials for those products,” said Still. “We’re also in the process of investing in a brand new fully automated manufacturing line that we hope to have available by the end of this calendar year.”

In 2021, Sense raised $65 million in a series B financing round led Koch Disruptive Technologies, a subsidiary of Koch Industries Inc. Proceeds from the round will be used to open a manufacturing capacity in Cambridge, England.

“Following our recent clinical trials, one of our top priorities has been expanding our facilities to bolster innovation and manufacture at scale to meet anticipated demand,” said Still. “These investments position us well to meet health care’s unmet needs for rapid, instrument free, high-quality molecular diagnostics for a variety of conditions. In addition, it positions us to address the emerging capacity guidelines from government agencies like the FDA for high volume production of COVID-19 tests.”

However, as European operations gear up, Still said Sense will look to raise more funds. “We are always looking at opportunities to raise capital to help us build out the company so we will be talking to folks throughout 2022. That process will start soon and we’re very excited by the future.”

According to a report by Insight Partners, the point-of-care molecular diagnostics market is projected to reach $5.3 billion by 2028 from $2.2 billion in 2021, at a CAGR of 13.4% from 2021 to 2028. Growth of the market is anticipated due to growing demand for specific viral detection methods which are affordable, convenient and can quickly limit rising cases of infectious diseases. However, pricing pressures owing to reimbursement cuts may restrain market growth.

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