An experimental blood test for pancreatic cancer, developed by scientists at Van Andel Institute (VAI) and the University of Pittsburgh, is advancing toward real-world application as it undergoes evaluation by a commercial laboratory. This marks a significant step in making the test accessible for patient use.
The research, recently published in Cancer Letters, detailed a double-blinded, peer-reviewed analysis revealing that the experimental test accurately identified 71% of pancreatic cancer samples in laboratory settings. This is a notable improvement over the current gold-standard test, which correctly identified only 44% of the samples. The test was developed through the collaborative efforts of Brian Haab, Ph.D., a VAI Professor, and Randall E. Brand, M.D., a physician-scientist and professor of medicine at the University of Pittsburgh.
Clinical Validation Process
Before the new test can be implemented in clinical diagnostics, it must undergo rigorous clinical validation. This process involves a CLIA-accredited diagnostics laboratory adapting the experimental test to ensure reliable performance under the stringent conditions of a clinical lab. CLIA, or Clinical Laboratory Improvement Amendments, represents a rigorous federal standard designed to ensure lab quality.
"Validation studies are essential for transforming a test developed in an academic lab into one that is used to diagnose real people. For a person being evaluated for pancreatic cancer, the stakes are high. Validation studies ensure that new tests work as intended," said Brian Haab, Ph.D., VAI Professor.
How the Test Works
The experimental blood test functions by detecting two specific sugars—CA199.STRA and CA19-9—that are produced by pancreatic cancer cells and released into the bloodstream. CA19-9 is currently the gold-standard biomarker used in pancreatic cancer detection. Dr. Haab's lab played a crucial role in identifying CA199.STRA as a novel cancer biomarker and developing the technology necessary for its detection.
The analysis also indicated that the new test significantly reduced the occurrence of false negatives while maintaining a low false-positive rate. These low rates are critical as they directly reflect the test's accuracy in identifying the presence or absence of cancer.
Clinical Validation by ReligenDx
ReligenDx, a CLIA-accredited diagnostics laboratory based in Pennsylvania, will conduct the clinical validation of the test. This process is anticipated to take approximately two years.
Potential Applications
If the clinical validation is successful, Dr. Haab envisions two primary applications for the test: early detection of pancreatic cancer in high-risk individuals, facilitating earlier treatment interventions, and monitoring disease progression and treatment response in patients already diagnosed with pancreatic cancer.
