NEW YORK (360Dx) – Lausanne, Switzerland-based Abionic has begun clinical evaluations of a CE-marked nanofluidic in vitro diagnostic assay that identifies sepsis using a fingerstick of blood within five minutes.
If all goes as planned, the assay, which received CE marking in January, could be on the market by the end of 2018.
The test combines a nanotech-based point-of-care ELISA with a pancreatic stone protein biomarker to identify sepsis and quantify the health risk for patients suspected of developing the potentially lethal infection.
"We are bringing together the best biomarker for sepsis detection with a rapid test platform, and we believe that the combination of the two may be disruptive for the patient in the ICU and emergency room," said Fabien Rebeaud, chief scientific officer, at Abionic.
The technology platform, abioSCOPE, was developed at the Swiss Federal Institute for Technology in Lausanne by Abionic Founder Nicolas Durand.
Although Abionics is cleared to launch its test in countries that accept CE marking "intensive care units and emergency rooms have certain work protocols, and our machine needs to be adapted and positioned for them in the perfect way," Susanne Emonet, vice president of sales and marketing at Abionic, said.
The PSP biomarker was discovered in the 1970s, but researchers at the University of Zurich realized only around 10 years ago that there was an association between the level of protein in the blood and the onset of sepsis in a patient.
"We were looking for a biomarker that would make sense for our platform, and because of the proximity of Zurich [to] Lausanne, we contacted the people who were working with PSP," Rebeaud said.
Philippe Eggimann, a physician working in infectious diseases and critical care at the Centre Hospitalier Universitaire Vaudois in Lausanne, and who has served as a scientific consultant to Abionic, said he believes that the Abionic sepsis test is potentially "very important."
"Integrating a biomarker that has a high sensitivity and specificity with a technology that can be mass produced and provide very rapid identification at a low price can potentially revolutionize the approach to early diagnosis and management of sepsis infection," he said.
Last week, Abionic announced "initial positive results from evaluation studies" conducted at two university hospitals — Zurich University Hospital, Switzerland, and University College London Hospital, UK.
In the Zurich University Hospital study, clinicians used the firm's platform to measure PSP in ICU patients each day for up to eight days. A lift in PSP values were observed up to 24 hours before the manifestation of clinical symptoms of sepsis, Emonet said.
Clinicians have found that in conducting studies with the Abionic test, PSP levels in burn patients rose 24 hours before a doctor knew that an infection was developing, which enables "treatment long before the infection is visible in any way," she added.
During testing at Zurich University Hospital, a rapid return of the PSP value to baseline was also observed during therapy, the firm said.
The abioSCOPE PSP test could, therefore, be used by doctors not only to initiate antibiotic treatment earlier, but also to monitor the effectiveness of therapy, Rebeaud said. Further, it is a valuable tool in showing clinicians and patients when an antibiotic is not the right treatment, a capability that could prove to be extremely valuable, he said, in the fight against a global rise in antibiotic resistance.
Rolf Graf, head of research in the department of surgery and transplantation at Zurich University Hospital, said in a statement that “A precise and accurate sepsis biomarker makes sense only if it is readily available to the clinicians, and as seen from the data generated in our recently completed study," the Abionic platform is unique in its capability to provide this kind of service.
Meanwhile, Niall MacCallum, leader of the critical care clinical trial team at University College London Hospital, said in a statement that the PSP test has the potential "to help us identify sepsis patients more quickly than with currently available technologies," and that "introducing such a test complies with recently released NICE objectives, as well as the guidelines issued earlier this year by the World Health Organization.”
With retrospective studies completed, Abionic will conduct observation-based studies to demonstrate the impact of the device and to convince hospitals of the value of the test, Rebeaud said, adding "We expect to have these studies completed in the middle of 2018, in alignment with our timeline for commercialization."
He noted that the firm is "talking with key hospitals" in Switzerland, France, Belgium, and the UK with a view to conducting observation studies.
Eggimann said that he believes that the company will be in a position to successfully complete its clinical studies within the next year or two.
Eggimann said that with early recognition of sepsis, clinicians can provide aggressive management of organ failure, a capability that has "improved the outcome of this disease."
Sepsis is the most common cause of mortality in intensive care units. It is a syndrome characterized by an overwhelming systemic response to infection that can rapidly lead to vital organ dysfunction and death, Eggimann said.
"After more than 20 years of active research in this field, we have found that the only thing that has proven to improve the outcome of severe sepsis and septic shock is rapid and aggressive recognition of the disease," Eggimann said. "It is not easy because the clinical signs are not specific," he added.
Although early recognition is the key, biomarkers sensitive and specific enough to adequately identify and characterize sepsis have not been available, he said.
"Several hundred biomarkers have been published over the last 25 years, but at the moment we are using white blood cell counting that is generally not specific; c-reactive protein, which is also not specific for infection because it can increase with inflammation of any origin; and procalcitonin." He said PCT is a better marker for sepsis than white blood cell counting or c-reactive protein. "It has improved the de-escalation of antibiotics in treating of sepsis," he said, but PSP has shown itself to be better than PCT and the other standard markers in clinical studies.
PSP, a non-inflammatory protein, is released by the pancreas and other cells when there's an immune response to an infection, he said.
"At least 10 published studies demonstrate that PSP is the most accurate biomarker for infection," he said. "Its window of expression is longer than for the other biomarkers, which means that the level of the marker does not decrease rapidly after the onset of an infection."
Importantly, it has been demonstrated that on the first blood draw, the level of PSP is correlated with the outcome of the infection, he noted.
In a clinical workflow, the Abionic test could be used along with tests that identify the specific sepsis-causing pathogen. "When you have identified that the patient is at risk of sepsis or has been infected, it makes sense to identify the pathogen and determine if this pathogen carries resistance to antibiotics," Rebeaud said. "Today, the gold standard in identifying a pathogen involves doing a blood culture which takes days," he said. However, more rapid molecular and other technologies are emerging that identify the pathogen and its resistance, he said, adding "We are working in line with all the developments that are occurring in molecular biology, because we are answering different questions and different needs."
Laboratories have been adopting rapid genotypic tests, including Luminex's Verigene and BioMerieux's FilmArray, that use blood samples in detecting antimicrobial resistance.
Abionic will compete in the market for sepsis identification with large in vitro diagnostic companies such as Roche, BioMérieux, and Thermo Fisher Scientific, each of whom has a US Food and Drug Administration-cleared PCT-biomarker test. In February, Accelerate Diagnostics received FDA clearance for its Pheno system, a platform that enables bacteria and yeast identification from a positive blood culture and provides a measurement of antimicrobial susceptibility within seven hours.
Founded in 2011, Abionic launched an IgE antibody-based allergy test on its platform at the end of 2015. The firm has received CE marking for an iron deficiency assay that runs on its platform. Both the allergy and iron-deficiency tests will be applied in doctors' offices at the point of care, Abionic said.
After developing the allergy assay, "we reflected on what would be the next application that would make sense for our platform, and we quickly identified a need for speed in the intensive care unit where a patient's condition can evolve quickly to a life-threatening situation," Rebeaud said. The firm realized that the test could be also used in emergency rooms "where you need to conduct risk stratification," and "a rapid test helps you decide what to do with the patient."
The firm, with about 30 employees, is seeking investments. It has completed Series A and Series B financing rounds, obtaining CHF 14 million ($14.5 million). For its Series C round, expected to start later this year, the firm is looking to obtain CHF 20 million that it would use primarily to finance clinical studies.
The firm said that it is in the "early stage of preparing documents" for a submission to obtain clearance from the US Food and Drug Administration, although the timeline for potentially receiving such clearance is unclear.