NEW YORK – After announcing new clinical data last week on the performance of its next-generation pancreatic cancer test PancreaSure, Swedish diagnostic firm Immunovia is preparing to launch the assay in the second half of 2025.
The results of the VERIFI study showed the antibody-based ELISA test had 77 percent sensitivity and 88 percent specificity when identifying early-stage pancreatic ductal adenocarcinoma, or PDAC, beating the study's primary endpoint of 65 percent sensitivity. Norma Palma, Immunovia's VP of clinical and medical affairs, said in a presentation that the multicenter study included 115 blood samples from patients with stages I and II pancreatic cancers and 271 high-risk patients who were healthy.
Thirty-one of the patients with cancer had a family history or genetic mutation that put them at high risk, while 16 had pancreatic cysts. Of the control patients, 53 percent were at high risk due to familial or genetic factors, while 19 percent had pancreatic cysts and 28 percent had both factors.
Palma noted that the sensitivity of PancreaSure in the VERIFI study was equivalent to the firm's previously completed CLARITI study despite a smaller sample size. Specificity, however, was lower than in CLARITI, likely due to the smaller cohort of control patients and VERIFI having more patients in the control group with pancreatic cysts — a particularly challenging high-risk population, she said. The firm also identified differences in specificity based on the site, she noted.
"We felt that the specificity was really strong in light of the high-risk population we're studying and the small control sample size," Palma said.
The specificity recorded in the VERIFI study is also in line with the specificity reported by two of the most common forms of screening for pancreatic cancer, magnetic resonance imaging and computed tomography, Immunovia CEO Jeff Borcherding said during the firm’s presentation.
He noted that it is difficult to identify early-stage pancreatic cancer via imaging and that the sensitivity for stage I and stage II pancreatic cancer with imaging is about 50 percent. While endoscopic ultrasounds have much better sensitivity than imaging, specificity is lower at 82 percent and the procedure is significantly more invasive and usually requires anesthesia.
The biomarker carbohydrate antigen 19-9, or CA 19-9, is also used for pancreatic cancer testing but is "generally used for people who've already had pancreatic cancer" and is less sensitive than PancreaSure, Borcherding added. PancreaSure includes CA 19-9 as one of its five biomarkers, along with tissue inhibitor of metalloproteinases 1, intercellular adhesion molecule 1, cathepsin D, and thrombospondin 1.
PancreaSure is the second version of Immunovia's pancreatic cancer test — the first, ImmRay PanCan-d, included nine biomarkers. The only biomarker used in PancreaSure that was also used in ImmRay PanCan-d is CA 19-9, he said in a follow-up interview after the presentation, but the original test was "so reliant" on CA 19-9 that if a patient had low levels of the biomarker, the test couldn’t produce a result for that patient.
PancreaSure also returns only a positive or negative result, while the original test included a less definitive borderline category, which Immunovia thinks will "help give better clarity to physicians about interpreting the results and deciding what to do next," Borcherding said.
While PancreaSure is protein-based like ImmRay PanCan-d, it uses a commercially available ELISA testing platform, the Dynex DSX, rather than Immunovia's proprietary protein measurement platform. This change has provided "a number of advantages," including that the Dynex system is more reliable, more precise, and costs less, he said.
ImmRay PanCan-d had other issues of its own. In 2022, the firm announced inconclusive results from a study evaluating ImmRay PanCan-d because sensitivity of the test couldn't be evaluated due to the low number of PDACs among patients.
Immunovia announced in 2023 that it would stop US commercialization of ImmRay PanCan-d and would restructure its operations, laying off many of its employees in both Sweden and the US.
The firm is "very much on the other side of that transformation now," Borcherding said, with a "small but really productive team in place" that is operating in a different way than it previously did to keep its cash burn low.
If it makes it to market, PancreaSure will compete with other blood-based tests for pancreatic cancer, such as ClearNote Health's epigenetic Avantect Pancreatic Cancer test, which received approval from the New York State Department of Health Clinical Laboratory Evaluation Program in February, and the University of Pittsburgh's next-generation sequencing-based PancreaSeq test, which has shown promise in correctly classifying pancreatic cysts. Mainz Biomed also has a pancreatic cancer test in development that uses multiplex real-time PCR to detect genetic biomarkers in stool samples.
Research groups from institutions like City of Hope's Translational Genomics Research Institute and Johns Hopkins University School of Medicine are also working on blood-based molecular tests for the disease.
Borcherding noted that by using proteins rather than circulating tumor DNA or gene expression, Immunovia may have an advantage in early-stage detection.
"From a clinical perspective, pancreatic cancer tumors tend to shed less in the early stages than what might be ideal" when using circulating tumor DNA, he said. "By using proteins, we're able to take a different path and we feel like that path gives us really good accuracy, especially sensitivity, for those stage I and stage II cancers."
According to the firm, the combined results of VERIFI and CLARITI, which include more than 1,400 blood samples with 317 cases of pancreatic cancer and 1,134 controls, show that PancreaSure has an overall sensitivity of 78 percent and specificity of 92 percent for early-stage cancer. In patients with pancreatic cysts, sensitivity is 72 percent and specificity is 89 percent, while in patients with diabetes, sensitivity is 80 percent and specificity is 90 percent and in patients with familial and genetic risk factors sensitivity is 78 percent and specificity is 94 percent.
The combined data "confirms for the first time that our test is effective across a number of different high-risk groups," according to Borcherding.
The validation of the test's performance in both studies supports Immunovia's strategic priorities, which are "focused on clinical studies to drive reimbursement" for PancreaSure, the company's "most important business objective," he said.
"Our goal is to make sure that we have a robust package of clinical studies, so that when we present that data to … government payors or those private commercial payors … we do get reimbursed for the test," he added.
Immunovia hopes to partner with a large diagnostics company that has existing commercial capabilities so that it can utilize a larger firm's resources, he added. "It just doesn't make economic sense for us to build a massive sales force of our own," Borcherding said. "There's certainly a lot that we can do to commercialize the test on our own, but for that, full national rollout across all the different physician groups that we want to reach, that's where the partner comes into play."
Borcherding said that Immunovia is "pretty flexible" on what the partnership will look like and its structure, noting that the "most important thing is to identify the right partner who sees the capabilities of the test." A partnership deal could involve a larger company licensing the test or inking a distribution agreement with Immunovia.
Immunovia plans to launch the assay as a laboratory-developed test to a targeted group of clinicians who run high-risk pancreatic cancer surveillance programs across the US in Q3 2025. Borcherding noted that there are about 200 high-risk programs in the US and targeting those areas first "allows us to commercialize the test on our own at a very reasonable cost and in a really capital-efficient way."
Many of these centers are struggling with capacity and the number of high-risk patients who need annual surveillance, so "having access to a blood test that would significantly increase their capacity" would be useful, Borcherding said. The first intended use population of the test would be patients with familial or genetic risk factors.
The firm is also working to make sure the final test report is easily understood and to automate the testing process as much as possible before launch, he added.
The US market is the company's "clear focus" for the foreseeable future, but Immunovia plans to "opportunistically look at other partnerships" outside of the US, as well.
The firm is currently finalizing a pre-submission information package for the US Food and Drug Administration that it plans to submit to the agency this week, he said. It also expects to seek regulatory approval outside of the US once the test is established in the US.
The company also has multiple other studies planned, including two conducted with the US National Institutes of Health focused on the pancreatic cyst population and one planned for patients with diabetes, he said. The firm is also working on clinical utility studies to support reimbursement. Immunovia also intends to publish the results of the VERIFI study in a peer-reviewed journal, Borcherding said.