NEW YORK – After receiving 510(k) clearance early this month from the US Food and Drug Administration for its sepsis test, Swiss diagnostics company Abionic is targeting the US for further commercialization of its assay.
A spinout of the École Polytechnique Fédérale de Lausanne in 2010, Abionic uses nanotechnology for its immunoassays, Abionic CEO Patrick Pestalozzi said. The firm's patented AbioScope platform is "effectively an ELISA in a box" that uses nanofluidic biosensors to reduce the distance between different layers in a sandwich immunoassay, enabling results to be returned much more quickly than with a traditional ELISA, he said.
The company began with a focus on allergy testing, launching an IgE antibody-based allergy test in 2015 but switched gears when there was an opportunity to exclusively license the pancreatic stone protein (PSP) biomarker from fellow Swiss biotech firm Lascco, Pestalozzi said. PSP is produced by the pancreas and immune cells in response to infections and inflammation.
Lascco has been presenting data on PSP since 2010, when it showed that PSP blood levels at admission to the intensive care units can stratify infected patients into two groups with distinct clinical characteristics and can predict risk of death within those groups. In 2017, Abionic released data from evaluation studies at two European hospitals that showed PSP levels rise as early as 24 hours before the manifestation of clinical symptoms in sepsis.
In a European multicenter study published in Critical Care in 2021 that analyzed the impact of serial measurements of three sepsis biomarkers, PSP was shown to begin increasing five days before the clinical diagnosis of sepsis. In comparison, commonly used sepsis biomarkers procalcitonin and C-reactive protein began to rise three days and two days before the clinical diagnosis, respectively.
According to Pestalozzi, PSP levels "seem to rise earlier in the blood … before other known markers" when sepsis is in the early stages, making it particularly beneficial for quick identification of patients who may be at risk. By leveraging that capability, Abionic's IVD Capsule PSP test uses a fingerstick sample of blood and an ELISA-based immunoassay to provide a readout of the levels of PSP in a patient's sample in less than 10 minutes, Pestalozzi said.
In contrast to some other rapid sepsis tests, Abionic's assay does not discriminate between viral or bacterial infections but is used to accelerate the time to detection of sepsis, which enables clinicians to perform other tests for species identification to guide appropriate antibiotic use, he said.
The test requires a three-step sample preparation process to mix the sample with the firm's Abiomix buffer mix, put it into the test capsule, and load it into the instrument. After that is completed, the actual incubation time is less than five minutes, he added.
The test received CE marking in 2017 and CE-IVDR certification in 2022 and was submitted to the FDA for 510(k) clearance at the beginning of this year.
Pestalozzi said that Abionic sees the test and the AbioScope platform being used in hospitals, emergency departments, and acute care settings. "The idea basically is to provide nurses and doctors at the point of care … the ability to, within a few minutes from a finger prick, test a patient on the suspicion of sepsis," he said. That result will help them decide whether to move the patient into the intensive care unit, for example.
Francois Ventura, a senior physician in the ICU at the Hirslanden Clinique des Grangettes in Geneva who previously served as chief medical officer at Abionic, said via email that his department uses the AbioScope every day mainly to measure PSP and help decide whether to start a patient on antibiotics. For patients that only stay in the ICU for a few days, such as postoperative patients, the test is run if a patient has a fever. Ventura said if the PSP is low, nothing is done, but if it is elevated the team runs additional tests and begins antibiotics.
For complicated patients who stay in the ICU for an extended time, the team measures PSP every day, and that serial testing, along with other clinical parameters, allows clinicians to detect nosocomial sepsis at an early stage, Ventura said. Daily monitoring is also used to help with the decision to stop antibiotics.
Ventura also cited the benefits of the test's earlier detection compared to CRP, PCT, or other common sepsis biomarkers. Because PSP rises earlier, "additional tests and antibiotics can be started earlier," he said. "And since mortality from sepsis increases by 8 percent with each hour's delay in administering antibiotics, PSP can be a game changer."
He noted, however, that there are clinical situations that make the interpretation of PSP more difficult, such as in patients with pancreatitis, pancreatic cancer and surgery, diabetes, renal failure, and renal replacement therapy.
Thus far, the company has largely focused on commercializing the test and the platform in Europe, although Pestalozzi noted that Abionic has more than 50 distribution channels around the world and has received regulatory approval in multiple countries, including Singapore, Malaysia, and Indonesia. The test has seen "decent uptake" in countries in Southern Europe, he added, while the company is building out its commercialization strategy for the US.
Abionic plans to launch the test in the US next year and is in the middle of conversations with strategic partners to help distribute the assay, Pestalozzi noted. It is also in the process of developing its US reimbursement strategy.
Because both the AbioScope platform and the PSP biomarker are new and relatively unheard of in the US, "a lot of work still needs to be done on the commercial side to communicate around this product," Pestalozzi said. The company thus far has been focused on developing the test and ensuring that it is effective, but with the new FDA clearance it has started to focus on commercialization.
Abionic is "moving away from being a pure R&D company to now being a lot more commercial, with a big drive to bring this product to the USA," Pestalozzi said.
Abionic is one of a number of companies trying to make a name for itself in the sepsis market — "many companies are vying for a piece of this action," Pestalozzi said. "Everybody's trying to solve the conundrum of sepsis," he added, and in his view Abionic has a chance to make its mark with early detection. "Early is better, no matter how you look at this."
While a variety of companies have tests to help identify pathogens and administer the correct antibiotics, "what's lacking in the space today is the ability to rapidly and easily screen people for sepsis," Pestalozzi said.
Rapid sepsis tests have been a keen area of interest for many diagnostics companies, such as Inflammatix, which raised $57 million in a Series E round this year to commercialize its blood-based test to help differentiate between bacterial and viral infections and determine the likelihood a patient will develop severe disease, and Immunexpress, which has commercialized a gene expression-based test to determine whether a patient's inflammatory response is because of sepsis.
Ad Astra Diagnostics, meantime, has received FDA clearance for a rapid point-of-care hematology analyzer that can identify when infections develop into sepsis by measuring immature granulocyte levels, another early marker of sepsis.
And Cytovale this month raised $100 million in a Series D round to accelerate commercial expansion of its 10-minute test to stratify patients by sepsis risk.
Although the AbioScope platform can be used with other tests, Pestalozzi noted that the company is "very much" focused on PSP and its sepsis test. It's "tough enough to focus on one product," so while the firm may eventually expand to different biomarkers, that expansion would be on a case-by-case basis.
"We'd like to be known as a sepsis company, basically. We're here for the early detection of sepsis," he said.