An innovative blood test for pancreatic cancer that was developed by scientists from the Van Andel Institute and the University of Pittsburgh is currently being tested by a commercial laboratory, marking a significant step towards making this test accessible to patients.
A recent double-blinded, peer-reviewed study published in Cancer Letters showed that this experimental test accurately detected 71% of pancreatic cancer samples, while the established gold-standard test only identified 44% correctly. This research was conducted by teams led by VAI Professor Brian Haab, Ph.D., and Dr. Randall E. Brand, a physician-scientist and medicine professor at the University of Pittsburgh.
To ensure the new test can be used for cancer diagnosis, it requires clinical validation. This process involves a CLIA-accredited diagnostics laboratory modifying the experimental test into a reliable version that meets the strict standards of clinical labs. CLIA stands for Clinical Laboratory Improvement Amendments, which sets high standards for laboratory quality.
“Validation studies play a crucial role in changing a test from an academic setting to one that can actually be used for diagnosing patients,” Haab mentioned. “For someone undergoing evaluation for pancreatic cancer, the situation is critical. Validation studies confirm that new tests perform as intended.”
This new test detects two sugars – CA199.STRA and CA19-9 – that are released into the bloodstream by pancreatic cancer cells. Currently, CA19-9 is the recognized gold-standard biomarker for pancreatic cancer. Haab’s lab has identified CA199.STRA as a new cancer biomarker and has developed the means to detect it.
According to the latest analysis, the new test significantly lowers the number of false negatives while keeping false positives at a minimal rate. Achieving low false positive and negative rates is critical as it indicates the test’s effectiveness in accurately determining the presence or absence of cancer.
ReligenDx, a CLIA-accredited diagnostic laboratory based in Pennsylvania, will carry out the clinical validation of this test. The entire validation process is expected to take approximately two years.
If the clinical validation proves successful, Haab foresees two main applications for the test: first, identifying pancreatic cancer sooner in individuals at high risk, allowing for earlier treatment, and second, monitoring disease progression and treatment responses in those already diagnosed with pancreatic cancer.
The research discussed in the Cancer Letters study received support from the National Cancer Institute of the National Institutes of Health through awards nos. U01CA200466 (Brand and Batra), U01CA200468 (Maitra), U01CA152653 (Haab, Allen, and Brand), U01CA226158 (Haab and Brand), and U24CA086368 (Zheng, Etzioni, and Feng); as well as from the Sheikh Khalifa bin Zayed Foundation (Maitra). The views expressed in this study are solely those of the authors and do not necessarily reflect the official stance of the National Institutes of Health or other funding entities.
