Novus Diagnostics: Dublin medtech with an award-winning idea for sepsis

8 Nov 2021

Elaine Spain, Keith O’Neill and Kellie Adamson. Image: Novus Diagnostics

A one-year-old start-up based on six years of research, Novus Diagnostics has developed a diagnostic device for sepsis patients who don’t have time to wait.

Novus Diagnostics started out under the name of its flagship product SepTec, a medical device for the quick and efficient screening of sepsis.

SepTec was dubbed the One to Watch at the 2018 Big Ideas showcase of science-led start-ups. With Enterprise Ireland now readying the 2021 Big Ideas event, Dr Elaine Spain and Dr Kellie Adamson have continued to see their star rise in the intervening years since their win.

They spun out as founders of Novus Diagnostics in 2020. Between them, Spain and Adamson have PhDs in physical inorganic chemistry, and diagnostics and therapeutics, respectively. Elements of both their postdoctoral research came together to build the idea behind Novus Diagnostics, an early-stage medtech start-up with backing from the European Innovation Council (EIC).

Last week, they were recognised with Science Foundation Ireland’s Commercialisation Award at a virtual ceremony celebrating leaders and innovators in Irish research. And, back in January, Novus was the only Irish company to be awarded funding in the first round from the EIC Accelerator pilot.

Another key development in the past year has been the addition of Dr Keith O’Neill to the team. O’Neill leads Novus Diagnostics as CEO, working alongside Spain as COO and Adamson as chief scientific officer. O’Neill joined Novus in May, bringing with him years of experience in the life sciences industry, with roles traversing the corporate, academic and public sector worlds. More than two decades of his career have been focused on the development and commercialisation of innovative healthcare products and services.

‘The whole process, from blood draw to result, can be completed within 15 minutes’

The EIC funding really accelerated progress for Novus Diagnostics, according to O’Neill. “Totalling €7.4m in a blend of grant and equity financing, [it] has enabled us to attract additional investment from private investors and Enterprise Ireland,” he said.

“We expect to close a €5m equity round towards the end of this year. On the back of this investment, we have expanded our team from three to six people in the past six months and plan to grow this further, to 10 to 12, by early next year.”

This team will further develop and commercialise the technology to rapidly diagnose a bloodstream infection as well as classify its causative agent, which means targeted treatment can be swiftly initiated.

“Today, most sepsis diagnoses rely on a lab test called blood culture,” said Spain, “which involves trying to grow the pathogen from the blood so it can be identified. This takes time, typically more than 12 hours and, in many cases, multiple days.”

One thing sepsis patients are critically short on, however, is time. This life-threatening toxic response to infection can kill a healthy person within hours. For patients with septic shock, there can be an 8pc increase in mortality for every hour of delay in treatment.

According to Spain, there are other issues with current tests for sepsis, whereby samples can be easily contaminated, leading to both false negatives and false positives. “Our technology avoids these problems,” she said.

The process, Spain explained, is simple. A standard blood sample is loaded into the SepTec disposable test cartridge, avoiding contamination and potential needle-stick injuries for healthcare workers. “The cartridge is then inserted into our shoe-box-sized portable analyser. The operator presses a button to start the test and a result is delivered automatically,” said Spain. “The whole process, from blood draw to result, can be completed within 15 minutes.”

The core technology behind this quick-fire test comes from more than six years of work and more than €1.4m in research investment. It was developed as part of Spain and Adamson’s postdoc research at Dublin City University (DCU).

“We combine novel electrochemical sensors with centrifugal microfluidics, automated sample processing and data analytics to deliver a new kind of biomedical diagnostics platform uniquely suited to point-of-care applications,” said Spain. Through this, SepTec can deliver fast results by a patient’s bedside, without the need for complex and lengthy sample preparation or specialised lab expertise.

‘There are great examples of creative approaches Ireland has taken to help seed a pipeline of innovative new start-ups’

Though the World Health Organization concedes that the worldwide burden of sepsis is hard to quantify, it cites one 2017 study that estimated it accounted for almost 20pc of all global deaths. To take on this global issue, Novus Diagnostics plans to start with emergency rooms and ICUs in the US, where it has been calculated that sepsis is the most expensive condition to treat.

O’Neill added that markets in the EU (such as the UK, Ireland, Germany and Spain) as well as the Asia-Pacific region, have also been identified as key territories for SepTec. “Each has a defined sepsis strategy and increasing incidence of sepsis,” he said.

Operating out of the National Institute for Cellular Biotechnology on the campus of DCU, Novus has built and successfully tested a working prototype for SepTec, with a patent pending. “We have also built a strong network of clinical partners who have indicated their interest in the technology, and their willingness to use it,” said Spain.

A clinical validation study is underway at Dublin’s Beaumont Hospital in partnership with Prof Ger Curley, a critical care specialist at the Royal College of Surgeons in Ireland. This is due to be completed before the end of this year, and the results will feed into large studies planned for the US in 2022.

SepTec offers many advantages in healthcare. Not only can it support clinical decision-making, improve patient outcomes and reduce costs, it can also help to reduce any unnecessary administering of antibiotics, a practice that contributes to antimicrobial resistance to medical treatment.

“Our ultimate goal is to save lives,” said O’Neill.

As well its EIC financing, Novus Diagnostics secured pre-seed backing of €1.4m from Enterprise Ireland, Science Foundation Ireland, EIT Health and sepsis charity Lil Red’s Legacy. Following on from the EIC Accelerator pilot financing, the start-up also has a commitment from EIC for an additional €2.5m as part of a future round if required.

The support of Curley, the team at Beaumont Hospital and Health Innovation Hub Ireland has also been vital on this journey.

“The [start-up] community here is hugely supportive and we have benefitted immensely from the help, guidance, advice and encouragement of investors, experts and entrepreneurs in the community as we worked to build our company,” said Spain.

While O’Neill added that there is certainly room for more Government support for entrepreneurship (and credited Scale Ireland’s work in trying to change that), he also noted those supports we can be proud of.

“Programmes like the Enterprise Ireland Commercialisation Fund which funded the early development of our technology, BioInnovate and Knowledge Transfer Ireland are all great examples of the creative approaches Ireland has taken to help seed a pipeline of innovative new start-ups,” he said.

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Elaine Burke is the host of For Tech’s Sake, a co-production from Silicon Republic and The HeadStuff Podcast Network. She was previously the editor of Silicon Republic.