This story has been updated from a previous version to clarify remarks made by Immunexpress CMO Roy Davis.
NEW YORK (GenomeWeb) – Under a partnership announced last week, Biocartis and Immunexpress are accelerating commercialization of the Immunexpress Septicyte test on Biocartis' Idylla RT-PCR platform, with a planned commercial release in the US by the end of 2019.
The Septicyte test, which received 510(k) clearance from the US Food and Drug Association last February, was initially planned to differentiate sepsis from systemic inflammation in critically ill patients as they arrived in the intensive care unit. However, Immunexpress believes working with Biocartis will help further its goal to integrate the technology into a point-of-care (POC) test because the platform takes about an hour to run an assay like Septicyte.
"Once we can get to a stage where the test is done in a short period of time, physicians will utilize it, rather than just part of a workup process," said Immunexpress CMO Roy Davis. The test is currently meant to be employed in the hospital setting and not in smaller practices and doctor's offices.
Running the Septicyte test on Idylla is also a major step in reducing hands-on time for the physician, Davis believes, as the firm's previous kit required a central lab technician to be trained to operate, calibrate, and examine the tests results. He sees the Idylla platform, a sample-to-answer testing machine, as a less resource-intensive way to produce results.
The Septicyte test uses the host's immune response to detect and distinguish between viral and bacterial infection. Immunexpress scientists and collaborators published a study in Scientific Reports in January 2017 describing the four-biomarker blood signature used by the test to identify viral infection as the cause of systemic inflammation. The biomarkers include interferon stimulated gene 15 (ISG15), interleukin 16 (IL16), 2',5′-oligoadenylate synthetase like (OASL), and adhesion G protein coupled receptor E5 (ADGRE5).
In a study published in PLOS Medicine in 2015, the Septicyte test was able to identify 90 percent of patients with sepsis in a 105-patient cohort (74 sepsis patients and 31 controls). While the test mistakenly identified some patients as having sepsis when they had infection-negative systemic inflammation, the authors believed that SeptiCyte might help doctors "make appropriate therapeutic decisions for patients with systemic inflammation."
Davis emphasized that while the test can detect the "presence of bacteria most likely found in hospitals, it is not capable of speciating bacteria, and does not detect drug-resistant bacteria." Immunexpress later clarified that the test can detect drug-resistant bacteria, but cannot differentiate drug-resistant from non-drug-resistant bacteria.
Immunexpress director of business development Leo McHugh explained that "when we listen to our potential customers, one of the main factors is turnaround time, [and] having a much better offering in turnaround time will greatly accelerate interest in our technology."
Run manually, Septicyte is currently able to produce a result in four to six hours from sample draw. On the Idylla platform, it could return a result in as little as one hour, said Biocartis CEO Herman Verrelst.
The collaboration is "a great market opportunity for us, especially if you go to the POC target approach that Idylla offers to [Immunexpress]," Verrelst said. He believes the test will also fit the makeup and positioning of the Idylla platform in the POC market, since the test can already rapidly test for sepsis in ICU patients.
Because of Biocartis and Immunexpress had collaborated on development of a gene expression assay for sepsis since 2012, Verrelest sees the new development agreement as the logical next step in the companies' partnership. He explained that the Idylla RT-qPCR platform is an ideal platform partner for the test because it allows for fully automated sample-to-result molecular diagnostics. Compared to manual PCR instruments, the Idylla platforms requires minimal hands on time without compromising the test's accuracy.
Both Davis and McHugh expressed interest in using the Idylla platform because it has already been used to commercialize other gene expression tests — including an FDA-cleared viral detection panel and several oncology assays — which will "accelerate Immunexpress commercially because Idylla is already an established manufactured line," McHugh said.
Because Biocartis' internal research and development currently focuses on building a menu in oncology, it is partnering with firms like Immunexpress to diagnose infectious diseases such as sepsis and bloodstream infections, Verrelst said.
Biocartis and Immunexpress are currently running feasibility testing on the Septicyte test. McHugh believes that they will finish the majority of the testing in Q2 2018. Immunexpress also aims to seek an additionial 510(k) clearance for SeptiCyte to run on the Idylla platform. In addition, McHugh foresees commercial placement for the Septicyte test in the US in late 2019.
"Having cleared what amounts to an equivalent assay in a kit format reduces the regulatory burden and risk for Immunexpress," McHugh explained. "The deal with Biocartis … effectively leapfrogs the manufacturing of the kit and puts us on a point-of-care platform."