NIH Researchers Identify Four-Marker Blood Test That May Improve Early Pancreatic Cancer Detection
•February 11, 2026
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Why It Matters
Early, accurate detection could shift pancreatic cancer from a terminal diagnosis to a treatable condition, reshaping screening strategies for high‑risk groups.
Key Takeaways
- •Four‑marker panel detects PDAC with 91.9% accuracy
- •Early‑stage detection sensitivity reaches 87.5%
- •Adds ANPEP and PIGR to improve specificity
- •Retrospective study; prospective validation still required
- •No FDA or commercialization roadmap disclosed yet
Pulse Analysis
Pancreatic ductal adenocarcinoma remains one of the deadliest cancers, largely because symptoms appear only after the tumor has metastasized. Current clinical tools, such as CA19‑9, suffer from low specificity—elevated levels can stem from benign pancreatitis or biliary obstruction—and a subset of patients lack the antigen altogether due to genetic variation. This diagnostic gap has spurred intensive research into multi‑analyte assays that can capture the heterogeneous biology of early‑stage disease, positioning blood‑based panels as a potential game‑changer for oncology labs.
The new four‑marker panel, unveiled in a Clinical Cancer Research article, integrates two established biomarkers—CA19‑9 and thrombospondin 2—with two novel proteins, aminopeptidase N and polymeric immunoglobulin receptor. In a retrospective analysis of banked samples, the combined assay correctly identified pancreatic cancer cases 91.9% of the time while maintaining a modest 5% false‑positive rate. Notably, for stage I and II tumors the sensitivity climbed to 87.5%, and the test distinguished malignant cases from pancreatitis and other benign pancreatic conditions—an achievement that many single‑marker approaches have failed to deliver. These performance metrics suggest the panel could serve as a pre‑diagnostic screen for high‑risk cohorts, such as individuals with hereditary risk factors.
Despite the promising data, the assay remains a research prototype. Prospective, pre‑diagnostic trials are essential to confirm real‑world effectiveness and to define appropriate clinical workflows. Moreover, the absence of a clear regulatory or commercialization pathway—whether as a laboratory‑developed test, a licensed diagnostic, or an FDA‑cleared kit—adds uncertainty for investors and clinical laboratories alike. If subsequent studies validate the findings, the panel could catalyze a shift toward routine blood‑based pancreatic cancer screening, opening new revenue streams for diagnostics firms and potentially improving survival outcomes for a disease that currently offers few early‑intervention options.
NIH Researchers Identify Four-Marker Blood Test That May Improve Early Pancreatic Cancer Detection
Promising retrospective results raise long‑term possibilities for labs, even as clinical and regulatory plans remain unclear.
NIH‑supported researchers have identified a new four‑marker blood test that may improve the early detection of pancreatic ductal adenocarcinoma (PDAC), one of the deadliest and most difficult cancers to diagnose at a treatable stage. The findings, published in Clinical Cancer Research, could have long‑term implications for clinical laboratories if the approach is validated in future studies, though significant hurdles remain before it could reach routine clinical use.
Pancreatic cancer has a notoriously poor prognosis, largely because it is often diagnosed after the disease has already advanced. According to the researchers, “only about 1 in 10 pancreatic cancer patients survive more than five years from diagnosis.” By contrast, survival improves substantially when tumors are detected early. However, as the authors note, “there are no current screening methods” capable of reliably identifying pancreatic cancer before symptoms appear.
Why Existing Markers Fall Short
In the study, investigators from the University of Pennsylvania’s Perelman School of Medicine and the Mayo Clinic used a phased, retrospective approach to evaluate blood‑based biomarkers using banked samples. Two previously studied markers—carbohydrate antigen 19‑9 (CA19‑9) and thrombospondin 2 (THBS2)—were included because of their historical relevance in pancreatic cancer research. CA19‑9, for example, is commonly used in clinical settings to monitor treatment response.
However, neither marker has proven suitable for population screening. CA19‑9 “can be elevated in people with benign conditions such as pancreatitis and bile duct obstruction,” and some individuals “don’t produce it at all due to genetic factors,” limiting its clinical specificity and sensitivity. These limitations are well known to laboratory professionals who routinely interpret CA19‑9 results in oncology workflows.
The researchers identified two additional proteins—aminopeptidase N (ANPEP) and polymeric immunoglobulin receptor (PIGR)—that were elevated in early‑stage pancreatic cancer patients compared with healthy controls. When combined with CA19‑9 and THBS2, the resulting four‑marker panel demonstrated improved performance.
For all cancer stages combined, the panel distinguished pancreatic cancer cases from non‑cases 91.9 % of the time at a false‑positive rate of 5 %. For early‑stage disease (stage I and II), the test identified 87.5 % of cases.
“By adding ANPEP and PIGR to the existing markers, we’ve significantly improved our ability to detect this cancer when it’s most treatable,” said lead investigator Kenneth Zaret, PhD. (Photo credit: Perelman School of Medicine at the University of Pennsylvania)
Encouraging Performance, Early Days
Importantly for clinical laboratories, the test was able to differentiate cancer patients not only from healthy individuals, but also from patients with non‑malignant pancreatic conditions, including pancreatitis—an area where many candidate biomarkers have historically struggled.
Despite the promising results, the authors stress that the findings are preliminary. “Our retrospective study findings warrant further testing in larger populations, particularly in people before they show symptoms,” Zaret said. He added that so‑called “prediagnostic” studies would be required to determine whether the assay could be used as a screening tool in high‑risk populations, such as individuals with a family history of pancreatic cancer or known genetic risk factors.
Notably, neither the NIH announcement nor the published coverage includes any public information about plans for FDA submission, commercialization, or clinical deployment of the test. There is no mention of whether the assay would be developed as a laboratory‑developed test (LDT), licensed to a diagnostics company, or pursued through a formal regulatory pathway.
For now, the four‑marker panel represents a research advance rather than a near‑term clinical offering. Still, it highlights how multi‑analyte blood tests may eventually reshape cancer screening—and presents an area for clinical laboratories to watch closely as validation studies progress.
—Janette Wider
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