Blood test for pancreatic cancer undergoes evaluation
An experimental blood test for pancreatic cancer is being evaluated by a commercial laboratory — an important milestone towards making the test available for patients. Teams led by the Van Andel Institute’s Professor Brian Haab and Professor Randall E Brand, from the University of Pittsburgh, created the test.
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.
A recent double-blinded, peer-reviewed analysis published in the journal Cancer Letters revealed 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. The test also greatly reduced the number of false negatives while maintaining a low false positive rate. 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.
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 (Clinical Laboratory Improvement Amendments) is a rigorous US 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.”
If successful in clinical validation, Haab envisions the test being used in two main ways: catching pancreatic cancer more quickly in people at high risk of the disease, which would enable earlier treatment; and monitoring progression and treatment response in people diagnosed with pancreatic cancer. Clinical validation will be conducted by ReligenDx, a CLIA-accredited diagnostics lab based in Pennsylvania, and is expected to take two years.
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