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Sense Biodetection Gearing up to Debut Instrument-Free Point-of-Care MDx

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NEW YORK – With a $15 million top-up on its recent Series B financing and its Veros platform now submitted to the US Food and Drug Administration, Sense Biodetection is gearing up to debut its instrument-free molecular approach.

The Abingdon, UK-based firm anticipates obtaining the CE mark for Veros in the first quarter of 2022 and expects to subsequently launch an Emergency Use Authorized COVID-19 test in the US, pending such authorization from the FDA.

Sense developed a proprietary enzyme-based isothermal nucleic acid amplification technology that it claims is highly sensitive and specific, providing molecular results in less than 15 minutes without the need for any instrumentation.

"We really see ourselves as the first truly disposable molecular platform that can be used at any convenient testing venue and ultimately by patients at home," said Timothy Still, the firm's president and CEO, in an interview.

Sense Biodetection is currently in the process of establishing its intellectual property and publishing data on the technology. As such, the firm has not disclosed the granular details of its isothermal method beyond that it uses a proprietary enzymatic process to separate the strands of nucleic acids followed by a controlled exponential amplification process.

"We're obviously not sharing all of the information about how the technology works until we are commercial," Still said.

Although the molecular diagnostic technology is isothermal, Still noted that it has performance characteristics that are "like PCR" and offer an improvement over other widely used isothermal methods, such as loop-mediated isothermal amplification, or LAMP.

And, unlike conventional PCR and some of the more common isothermal technologies, Sense's method has been developed specifically for deployment in a single-use, disposable automated test device, Still said.

The Veros platform also boasts operation across a wide temperature range, he said, as well as an integrated "high-contrast visual readout," without the constraints of a thermal cycling instrument, a reader instrument, or any external power supply.

Similar isothermal technologies that have debuted during the SARS-CoV-2 pandemic include a LAMP-based assay with additional enzymatic tweaks called FRANKD from Poland-based firm GeneMe that has claimed particularly high sensitivity for a LAMP test. An isothermal method called exponential amplification reaction, or EXPAR, was also recently paired with rapid sample prep to bring testing time down to five minutes by a team in the UK. And, molecular diagnostic systems from Lucira Health and Cue Health are based on isothermal chemistries, albeit with requirements for small instruments, and these firms have already obtained EUA for COVID-19 tests.

Besides isothermal amplification at the point of care, there are also numerous handheld PCR systems commercialized or in development, including single-use disposable PCR from firms like Nuclein and Visby Medical.

Gearing up

The data from Sense's clinical trials to support the EUA indicate the technology is as sensitive and specific as lab-based RT-PCR testing, Still said, if not better in some cases. This is also a dramatic improvement over antigen testing but with a similar workflow of "swab, swirl, and test," he said.

Former Cepheid CEO John Bishop, who is a member of Sense's board of directors, has long been dedicated to extending the point of care to its most distal potential, having guided Cepheid's initial development of the Omni remote testing instrument.

Bishop said in an interview that the COVID-19 pandemic has highlighted the global need to "have diagnostics be routinely available, broadly disseminated, and moving into an at-home testing scenario."

For this to happen, however, test accuracy is critical, as is ease of use and time to result. And although there are "many good systems out there now, including Cepheid's," Bishop said, most can't be used at home without an instrument. "That is the thing to me that makes Sense unique," he said.

Isothermal technologies have also been around for years, but they have "generally been inferior in overall accuracy as compared to PCR," Bishop said. On the other hand, "Sense has refined the chemistry and isothermal technology such that they are getting very good accuracy with [the Veros], pretty close to that of PCR technology," he added.

Bishop further noted that, because each Veros is an independent disposable reaction device, it can be deployed in mass testing scenarios, like airport screening, without any limits on throughput.

Still noted that Bishop has been very vocal about securing the supply chain, and Sense's new funding may also give it a leg up in terms of the current sourcing issues facing the industry.

Sense has a molecular discovery group in Oxford, UK, and a biomanufacturing and product development facility in Cambridge, UK. It also has a small distribution hub near Boston, Massachusetts.

But the Veros will be assembled and finished by contract manufacturer Phillips-Medisize Corp. in Hudson, Wisconsin.

Still noted that PMC is a subsidiary of microprocessor maker Molex, which is in turn owned by the Koch Group. Veros so impressed executives at PMC, they reached out to Koch Disruptive Technologies, an investment firm associated with the Koch Group, Still said, leading to KDT recently providing funds to Sense.

In 2019, Sense raised £12.3 million ($15.9 million) in a Series A round that included investment from Cambridge Innovation Capital and Mercia Asset Management, and its Series B round raised $50 million in April, with an additional $15 million added in November coming primarily from KDT.

Still said that this relationship makes the firm reasonably confident that it can get priority for supply chain and manufacturing, as its largest investor owns its contract manufacturer.

"Even though Veros is a disposable device, we do have chips and we do have parts that are being constrained, unfortunately, by the supply chain," Still noted.

Sense also expects to reap the negotiating power and benefits of high-volume purchasing through its Molex connection, Still also said.

"Molex is a multibillion-dollar organization, and they have negotiating power a lot larger than what Sense Biodetection could ever dream to have," he said. "If they call and say, 'We'd like to place an order for chips,' ... they have a lot more leverage."

Sense is currently placing its orders for supplies and reagents out to 2023, Still said.

Sense Biodetection was originally founded in 2014 in Oxford, UK, by two brothers, Harry and Ralph Lamble. The brothers had lost a sibling to cancer, and the experience drove their desire to make diagnostics faster and easier to use, Still said.

After COVID-19, the firm is developing assays for other respiratory ailments, but Still noted sexually transmitted infection testing and other infectious diseases are in the R&D pipeline, with oncology assays in the firm's long-range plans.

Earlier this year it brought on Simon Turner as chief financial officer and Ryan Roberts as chief commercial officer. Turner had previously served as VP of finance and administration at Oxford Immunotec, while Roberts was CCO at point-of-care diagnostics company Astute Medical prior to that firm's acquisition by BioMérieux.

Sense currently has 60 employees but plans to increase that headcount, and it also is growing its manufacturing footprint with the new funding, adding capacity and manufacturing lines, Still said, as well as increasing research and development activities.

"We are on the cusp of commercialization, so as we go out on the market in the UK and other European countries in Q1, and when we ultimately get EUA approval here in the US, we are going to need some additional capital to hire commercial teams," Still said.

Nevertheless, "COVID has really changed the game," he said, and there are now many more opportunities to market directly to professionals. "We are actually being approached by large customers and channel partners. It is really an opportunistic time at the moment."

Going forward, Sense expects to begin selling to customers for testing in settings like clinics, nursing homes, pharmacies, and sports arenas, with an ultimate goal of offering at-home molecular testing.

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