NEW YORK – Great North Research & Innovation was recently awarded £243,000 ($319,000) to develop a bedside instrument for the rapid diagnosis of sepsis.
The funding, made available through Innovate UK, the UK's national innovation agency, should help the nascent diagnostics company make progress on its aim to have a working prototype of the test finished by year-end. The project will commence in June and will run through December.
Georgios Gerardos, GNRI's chief technology officer, founded the company in 2016 to develop and commercialize technology he developed while working as a pediatrician within the UK National Health Service in Newcastle, UK. He said that sepsis is an increasing problem in neonatal intensive care units, particularly because diagnosis still relies on blood cultures, which can take up to five days to return a positive or negative result.
As sepsis can be fatal in neonates, they are often given antibiotics and are admitted to intensive care units if they present with any symptoms of sepsis. This can lead to unnecessary interventions, pushing up healthcare costs, and separating newborns from their mothers at a crucial time in development.
"It's a complex problem," said Gerardos. "It could just be that the baby has distress from the delivery, but blood cultures take up to five days and during this time I cannot declare a blood culture negative."
According to the UK Sepsis Trust, about 52,000 people die from the condition annually, a thousand of whom are children. Roughly 250,000 people are treated for sepsis in the UK each year.
To address this healthcare burden, Gerardos turned to molecular testing, working to develop a technique that could identify bacteria or fungi in a blood sample within a two-hour time frame and at bedside. Great North Research & Innovation has been tight-lipped about the approach, but Gerardos said the device in development should be about the size of a laser printer. He has not published the technique either.
In 2016, he was awarded a Start-Up Foundership by Newcastle University to continue to work on the concept, which included a stipend and small grant (currently about £7,000 and £10,000, respectively). Newcastle encouraged Gerardos to pursue a commercial avenue for the test platform. As such, GNRI was conceived within Newcastle and fostered by the university, but is not a spinout. In 2017, the company raised undisclosed funds from angel investors to continue investment and has worked on development since then.
"We have made progress and expect to have a prototype of the device ready by the end of this year, before Christmas if all goes well," said Gerardos. The premise of the platform is straightforward: a printer-sized unit installed at the point of care that can provide a diagnosis within a two-hour time window and "deliver results back to the clinical team, with which they can plan proper management."
GNRI is currently a small startup, employing a handful of people focused on developing the prototype, but is preparing to scale within the next few years as it has something in hand it can bring to market. Gerardos said that work is complete on the model, its design and manufacturing, and that software is currently under development, as is the integration of the entire system, efforts that the injection of Innovate UK funding will finance.
Beyond product development, the company is looking for partners, whether they could assist in getting the test into hospitals or have a commercial interest in working with GNRI. The firm is also scouting other sources of funding to support development of the technology and to make it more readily available in the healthcare setting, Gerardos said. He noted that the UK has been making more funding available to support new technology companies in recent years, as well.
In terms of adoption, as a former NHS clinician, Gerardos noted that his company is creating a technology that will replace a test that is already being done — blood culture. As such educating the market might be less of a problem than it is for other kinds of innovative approaches.
"If you develop a machine that can do a test faster, the clinician will always adopt it, because why not, it has already been done," remarked Gerardos. "We therefore expect to be working within the current workflow in the NHS and other healthcare systems," he said.
Gerardos acknowledged that GNRI is not the only company that has taken an interest in meeting the challenges of sepsis with a point-of-care molecular testing platform. There are perhaps dozens of firms developing tests using a variety of technologies. Molzym, for example, is currently working with Fraunhofer Institute to develop a next-generation, multiplex sepsis test.
According to Gerardos, molecular tests deployed to date have largely missed the mark. He noted that the UK National Institute for Care and Health Excellence, which provides national guidance on improving healthcare in the UK, reviewed several molecular tests for sepsis, and has recommended not using them, first in 2016 and again in 2020, citing issues with sensitivity versus traditional blood cultures.
"They came to the same conclusion, that they are not good enough," said Gerardos of the NICE review. "They usually take too long, are too expensive, and have high false positives," he said, "and therefore cannot be recommended for use in identifying pathogens or sepsis."
When asked though of how GNRI will succeed where others have thus far failed, he said that the company has "found ways around traditional hurdles" that will allow it to know if there is a pathogen in a patient's blood sample and what it could be.