A Pancreas-Specific Blood Test Reaches Key Validation Milestones

For people at increased hereditary or familial risk of pancreatic cancer, screening often means yearly MRIs or endoscopic ultrasounds.

These can be time-consuming, invasive, and expensive. And even with regular imaging, some cancers can still slip through in the months between tests.

So the idea of a simple blood draw that might help detect pancreatic cancer at its earliest, most treatable stage is extremely attractive to scientists and patients alike, and many have been eagerly tracking the development of such liquid biopsy tests. One of the newest of these tests—PancreaSure, developed by Immunovia, Inc.—is drawing attention after recent validation studies.

According to Bryson Katona, M.D., Ph.D., Director of the Gastrointestinal Cancer Genetics Program at Penn Medicine’s Abramson Cancer Center (Philadelphia, Pennsylvania) and a lead author on multiple papers about the test, the results are “very promising,” while noting that real-world performance still needs to be proven.

How the Test Was Developed and Validated

PancreaSure is currently the second pancreas-cancer-specific blood test from Immunovia. The company’s first version, IMMray PanCan-d, was available for about two years but was eventually withdrawn. The new test reflects lessons learned from that earlier experience.

While many emerging tests aim to detect multiple cancers at once, PancreaSure was designed and validated specifically for pancreatic cancer, using large numbers of early-stage (stage I and II) samples—something that’s surprisingly hard to obtain since most people present with stage III or IV disease.

“Validating a test on stage IV cancers isn’t very helpful for early detection, so using these early-stage samples is incredibly important,” says Katona, who serves on the Scientific Advisory Board for Immunovia and was involved in the development and validation of the updated test.

The model was developed using 623 patient samples, including 128 early-stage pancreatic cancers and 465 high-risk controls. Two independent validation studies—the CLARITI study, published in October 2025 in Gastroenterology, and VERIFI, published in Current Oncology —tested the algorithm on new separate sample sets totaling 317 early-stage cancers and 1,134 high-risk controls using banked blood samples.

Earlier blood tests for pancreatic cancer often focused on one main biomarker, most commonly CA 19-9, a glycoprotein that can be elevated in pancreatic cancer, but also in other noncancer conditions. Importantly, 10-15 percent of people don’t produce CA 19-9 at all.

PancreaSure takes a different approach. It measures five biomarkers, one of which is CA 19-9. But unlike the first-generation IMMray test, this new algorithm can still provide results even for people who do not express CA19-9.

Across the two studies, the PancreaSure test detected 78 percent of stage I and II cases of pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The test demonstrated specificity of 92 percent, correctly characterizing approximately 19 of 20 noncancerous high-risk control samples as “negative.”

The design of the study was guided by clinical collaborators and external authors from 14 different institutions, and the hundreds of rare blood samples used in the study were provided by an extensive network of pancreatic cancer surveillance centers, including many in the PRECEDE Consortium.

How the Test Might Fit Into The Screening Schedule

One of the limitations of the CLARITI study is that the data come from previously-collected samples. The next step will be testing it in people actively undergoing surveillance.

“Until we have prospective data, we don’t truly know how useful it will be. And that data will be years down the road,” Katona explains.

Still, experts can already imagine where the test might fit:

1. As a six-month check between yearly imaging

Most high-risk patients receive MRIs or endoscopic ultrasounds once a year. PancreaSure could give doctors something to look at between those annual scans.

“If positive, maybe it could trigger imaging at the six-month mark,” Katona says.

2. For patients who hesitate to undergo imaging

Some people avoid recommended imaging because of cost, invasiveness, anxiety, or medical risk.

“For those patients, something may be better than nothing,” Katona explains. “If a blood test were positive, it might motivate them to get imaging.”

A blood test is also appealing for patients who juggle other regular screenings as well, such as breast, prostate, or colorectal cancer. And it could help ease some of the anxiety some people experience with imaging.

“Even though yearly imaging is good, it’s not perfect. A blood test could offer a less burdensome way to check in more often,” Katona adds.

Finding new ways to improve pancreatic cancer early detection has been a major interest for Katona and many other researchers, who are working on it from several different angles, including stool and urine tests.

There’s also excitement around AI-enhanced imaging, which could examine pancreatic scans in new ways. Some pancreatic cancers might leave subtle early signs on a “normal” MRI—signals too faint for radiologists to detect but potentially visible to machine-learning systems. Such tools could eventually help flag patients who need more frequent imaging—even before obvious changes appear—or identify potential cancer in those who had imaging done for other reasons.

A Hopeful Step Forward—With Important Caveats

For people at elevated risk—especially those who have watched a family member suffer from pancreatic cancer—every new tool brings a mixture of hope and urgency.

“It’s a very impactful cancer,” Katona notes. “People are looking for any piece of information that can help with early diagnosis and decision making.” He reminds patients and providers that PancreaSure is promising but still new. It won’t replace imaging, and its full clinical value won’t be known for several years.

“Doctors shouldn’t just order this test like they’re ordering a blood count or a metabolic panel,” he adds. “Patients need to be counseled about the uncertainties. I’ve ordered it for a number of patients, but only after discussing what we know and what we don’t know.”

Cost is another factor. PancreaSure is not yet covered by insurance, though Katona praises the company’s transparent pricing structure, with discounts for prompt payment, payment plans based on income, and a policy that checks with patients to ensure they approve it if thepatient’s out-of-pocket cost exceeds a certain amount.

“That’s important,” he says. “The last thing I want is for someone to get stuck with a bill they don’t want or can’t afford.”

But the test represents meaningful progress toward a future where catching pancreatic cancer early is more realistic, and Katona said he’s looking forward to seeing it further validated in the field.