When Elaine Spain was growing up, she wanted for a time to be a vet, and then a teacher. Secondary school revealed a natural ability for science, enhanced by a love of forensic science TV shows.
Today, after a BSc in Analytical Science and PhD in Electrochemical Sensors, Elaine is co-developer of SepTec, an in-vitro diagnostic device that screens blood for the diagnosis of sepsis, identifying pathogens within 15 minutes. Broadly speaking, pathogens are anything that can produce disease.
Sepsis is an often-fatal condition. The body launches an overpowering immune response to an infection that causes more damage to the body than the infection itself. A critical unmet need in combating sepsis is speed of diagnosis. Current clinical diagnosis times are one to five days depending on the pathogen type. An insidious condition, sepsis symptoms are non-specific. Patients present with flu-like symptoms such as shivering or aches/pains. Often sepsis goes undiagnosed.
Elaine describes sepsis as “an equal-opportunity killer, impacting people of all ages and levels of health”. In fact, she says, “every three heartbeats someone in the world dies of sepsis”.
SepTec addresses the critical issues of time and accuracy with the condition. It combines screening and pathogen identification in one compact, near-patient instrument. By being near-patient rather than lab-based, SepTec is more cost-effective, portable, easier-to-use and extends the facility to do more testing in a greater range of care settings.
Current protocol requires clinical staff to prescribe any patient that is suspected of having sepsis with a broad-spectrum antibiotic. However, these are only successful 30 per cent of the time.
More than that, Elaine explains: “SepTec improves patient outcomes by providing rapid identification of the cause of a patient’s sepsis and it will reduce the inappropriate use of antibiotics that leads to the proliferation of antibiotic resistant pathogens.”
The global problem of antibiotic resistance is fast becoming one of our major scientific issues. Bacterial resistance is undermining existing drugs, posing a serious threat as ordinary infections become untreatable.
Right now, there are no ‘bedside early’ (less than one hour) detection strategies for blood stream pathogens associated with sepsis. When validated, SepTec will help clinicians with diagnosis, prognosis and treatment, reducing mortality rates, hospital stays and recovery times. Clinicians and healthcare providers will experience improved patient care and outcomes as well as cutting bed-stays and cost-savings from reduced price testing.
Elaine and her co-developer Kellie Adamson have received support from Enterprise Ireland to the tune of €600,000 that has proven their work to date. Presently, they are supported by SFI and receiving funding of €200,000 to further de-risk the technology. Developing a product that uses new technologies contains risk. Therefore, it is important to understand these early and have strategies to mitigate them.
Based at the National Centre for Sensor Research in Dublin City University, the SepTec team has developed and refined a proof-of-concept – evidence that SepTec is feasible – and a working prototype, which was tested in-lab and on patient blood samples.
"Our R&D is mainly focused on ICU patients in Beaumont Hospital. The ICU population was chosen as the prevalence of blood stream infection is higher among this cohort."
Clinical validation studies are imminent to verify SepTec’s capabilities. Approximately 200 patients will be enrolled at Beaumont Hospital over a three-month period; results will be compared to the gold standard blood culture system.
There is still a road to travel but when available, SepTec will allow a physician rapidly identify sepsis and administer the appropriate therapy. Equally significant, by quickly ruling out the condition, SepTec will contribute to the global goal of reducing antibiotic use and stop antimicrobial resistance occurring.
Discussing innovation, Elaine says that for her it means change.
“We are bringing a new unique product to the market, Irish-created and Irish -developed and we hope to change current clinical practice worldwide.”