NEW YORK ─ Immunexpress and its partner Biocartis plan to introduce a new, rapid test for sepsis in Europe this quarter ahead of a potential US Food and Drug Administration 510(k) clearance for the assay later this year.
The companies are positioning the test, called SeptiCyte Rapid, to triage COVID-19 patients who could be at greater risk for progressing to sepsis. Mechelen, Belgium-based Biocartis also sells a diagnostic for SARS-CoV-2, the virus that causes the disease, and will be marketing both tests for use on its Idylla system. The company also is seeking an FDA Emergency Use Authorization for its SARS-CoV-2 test.
Dirk Zimmerman, global head of pharma collaborations and partnering at Biocartis, said that, based on discussions with several key opinion leaders, there is a lot of "enthusiasm and appetite" in the European market for the assay, for which Immunexpress garnered a CE-IVD mark in March. At that time, the firms announced a co-commercialization agreement that gives Biocartis exclusive rights to sell and distribute the test in Europe, while Seattle-based Immunexpress retains its exclusive rights to the US market.
The Immunxpress SeptiCyte Rapid test relies on real-time PCR to determine which patients have sepsis and which ones are suffering from infection-negative systemic inflammation. It accomplishes this by gauging host response as demonstrated by their gene expression profile. The markers in the panel include phospholipase A2 group VII platelet activating factor, placental-specific 8, carcinaoembryonic antigen-related cell adhesion molecule 4, and lysosomal-associated membrane protein 1. The turnaround time for the test is about an hour.
Biocartis first gained a CE-IVD mark for its automated Idylla molecular testing system in 2014 and has since built up a portfolio of oncology and infectious disease assays on the benchtop system. The company currently employs around 500 people and has a sales team of 40 people in Europe to support the roll out of SeptiCyte Rapid, Zimmerman noted.
"We have been active in Europe for many years and have been building a commercial network for more than five years," noted Zimmerman. "We can leverage our network to commercialize the test."
Zimmerman noted that Biocartis will also work with first adopters to support studies on the platform in Europe to generate data relevant to regional adopters. He noted that European labs often want to see data generated in Europe, similar to US labs that want to see data generated by users in the US. "We are gathering data to support Immunexpress that way," he said.
The partnership is an auspicious one for Immunexpress, which employs 16 people between its headquarters in Seattle and office in Brisbane, Australia. The company in 2017 gained US Food and Drug Administration clearance for another version of the assay based on the Applied Biosystems 3500 Dx genetic analyzer, now sold by Thermo Fisher Scientific, but the turnaround time was between six and eight hours and was designed to be processed in a central laboratory.
In 2018, it announced a partnership to transfer the SeptiCyte Lab test to the Idylla platform. According to Immunexpress CEO Rolland Carlson, the experience on the platforms allowed the company to generate data to demonstrate the performance of the assay on different test systems. "We found high concordance," he said.
The company since has been working toward gaining a CE-IVD mark as well as FDA clearance for SeptiCyte Rapid and had both retrospective and prospective studies underway when the recent COVID-19 pandemic hit earlier this year. He noted that the company opened its clinical studies to include COVID-19 patients.
"The nature of our technology is such that we can measure sepsis that include bacterial, fungal, or viral pathogens," noted Carlson. "It is independent of what the pathogen specifically is," he said. By including patients with the new coronavirus, they "can make sure in a COVID-19 world that the test is validated in patients with viral-induced sepsis as well as other viruses," he said. "It would be the same for other coronaviruses."
Since sepsis is a common complication in COVID-19, such a test could be attractive to clinicians looking to decide on treatments for those afflicted. "Clinicians are very interested in looking at technologies that can measure the potential progression of disease and the severity of disease and that fits right in with what we have already been doing in our clinical studies," Carlson said.
The US government also took note. In June, the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority awarded Immunexpress nearly $600,000 to develop SeptiCyte Rapid as a tool for identifying SARS-CoV-2 patients with an elevated risk for viral or secondary bacterial sepsis. The firm said at the time it would use the funding to validate the test as a triage tool, as well as to pursue Emergency Use Authorization with the FDA.
Carlson affirmed that the company is on track to achieve FDA clearance by the end of 2020. In the meantime, Immunexpress is building a sales and marketing team to support the eventual introduction of the test in the US, following the commercialization of SeptiCyte Rapid in Europe. Of the company's relationship with Biocartis, Carlson noted that Immunexpress has a "strong working relationship" with the company and maintains a worldwide license to its technology.
"We can work independently, and can sell both the platform and assays independently," said Carlson. "They have done a good job in penetrating the market, particularly in Europe, so collaborating with them makes total sense," he said.
Beyond Europe and the US, Carlson said that the company would evaluate its commercial plans on a region by region basis, and would sell either directly or via partners.
Looking ahead, he noted that Immunexpress continues to work on its diagnostic pipeline, which remains centered on measuring host response, an approach he said he found "novel and compelling" and that prompted him in part to take the helm of the firm two years ago after serving as CEO of WaferGen for several years. Immunexpress is currently focused on developing host response assays for specific different viral and bacterial pathogens, he noted.
In July the company published a paper in BMC Medicine that detailed two new signatures, one for viruses called SeptiCyte Virus, and another for bacterial infections called SeptiCyte Triage. While the firm had previously described SeptuCyte Virus, SeptiCyte Triage was specifically developed and validated to help rule out bacterial infections in patients presenting in emergency care. By using it together with SeptiCyte Virus, Carlson said the test could provide clinicians with "high confidence and actionable results for withholding antibiotics in patients with low probability of bacterial infection."
The company is currently incorporating the signatures into technology into a test for use in intensive care settings, as well as other healthcare settings, he said.