An experimental blood test for pancreatic cancer that was developed by Van Andel Institute and University of Pittsburgh scientists is being evaluated by a commercial laboratory, an important milestone toward making the test available for patients.
A recent double-blinded, peer-reviewed analysis published in Cancer Lettersrevealed that the experimental test correctly identified 71% of pancreatic cancer samples in the lab compared to only 44% correctly identified by the current gold-standard test. Teams led by VAI Professor Brian Haab, Ph.D., and Randall E. Brand, M.D., a physician-scientist and professor of medicine at the University of Pittsburgh, created the test.
Before the new test can be used by doctors to diagnose cancer, it must undergo clinical validation. During this process, a CLIA-accredited diagnostics laboratory adapts the experimental test into a version that reliably works under the strict conditions in a clinical lab. CLIA is a rigorous federal standard that ensures lab quality.
“Validation studies are essential for transforming a test developed in an academic lab into one that is used to diagnose real people,” Haab said. “For a person being evaluated for pancreatic cancer, the stakes are high. Validation studies ensure that new tests work as intended.”
The new test works by detecting two sugars — CA199.STRA and CA19-9 — that are produced by pancreatic cancer cells and escape into the bloodstream. CA19-9 is the current gold-standard biomarker for pancreatic cancer. Haab’s lab identified CA199.STRA as a cancer biomarker and developed the technology to detect it.
The new test also greatly reduced the number of false negatives while maintaining a low false positive rate, according to the recent analysis. Low rates of false positives and false negatives are important because they reflect the test’s ability to correctly identify the presence or absence of cancer.
Clinical validation of the test will be conducted by ReligenDx, a CLIA-accredited diagnostics lab based in Pennsylvania. The process is expected to take two years.
If successful in clinical validation, Haab envisions the test being used in two main ways: 1. Catching pancreatic cancer more quickly in people at high risk of the disease, which would enable earlier treatment and 2. Monitoring progression and treatment response in people diagnosed with pancreatic cancer.
Research reported in the Cancer Letters study was supported by the National Cancer Institute of the National Institutes of Health under award nos. U01CA200466 (Brand and Batra), U01CA200468 (Maitra), U01CA152653 (Haab, Allen and Brand), U01CA226158 (Haab and Brand), and U24CA086368 (Zheng, Etzioni and Feng); and the Sheikh Khalifa bin Zayed Foundation (Maitra). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or other funders.