A groundbreaking blood test designed for early detection of pancreatic cancer is currently under evaluation at a commercial lab, a result of collaboration between researchers from the Van Andel Institute and the University of Pittsburgh.
This represents an important advancement towards making this promising diagnostic tool accessible to patients.
Test Efficacy and Findings
The test’s efficacy shines through recent findings published in the esteemed journal Cancer Letters.
In a double-blind, peer-reviewed study, the new test accurately identified 71% of pancreatic cancer cases from laboratory samples, significantly outperforming the current gold-standard test, which detects only 44% of cases.
Professor Brian Haab, Ph.D., from Van Andel Institute, led this pivotal research alongside Dr. Randall E. Brand, a respected medicine professor and physician-scientist at the University of Pittsburgh.
Clinical Validation Process
Before this innovative blood test can be integrated into clinical practice, it requires a thorough clinical validation process.
In this stage, a laboratory accredited under the Clinical Laboratory Improvement Amendments (CLIA) will adapt the experimental test into a clinical-grade version that meets rigorous standards for reliability and accuracy.
These federal regulations are crucial for ensuring laboratory quality.
Professor Haab highlighted the importance of validation studies in transitioning from an academic environment to real-world clinical application.
He noted that successful validation could profoundly impact how patients suspected of having pancreatic cancer are treated, emphasizing its potential to influence patient care significantly.
Innovation in Cancer Detection
This advanced test pinpoints two specific sugars—CA199.STRA and CA19-9—that pancreatic cancer cells release into the bloodstream.
While CA19-9 is a well-known biomarker for the disease, Haab’s lab has confirmed CA199.STRA as a valuable cancer indicator as well.
The study also underscores the test’s effectiveness in reducing false negatives while maintaining a remarkably low false positive rate.
This dual performance is critical, as any cancer detection method must accurately determine whether the disease is present or absent.
Clinical validation will be conducted by ReligenDx, a Pennsylvania-based laboratory meeting CLIA standards, with the entire process expected to take around two years.
If validation is successful, Haab envisions the test fulfilling two vital roles: it could enable early detection of pancreatic cancer in high-risk individuals, allowing for timely interventions, and it could also aid in tracking disease progression and treatment effectiveness in those already diagnosed.
The research detailed in Cancer Letters received funding from the National Cancer Institute of the National Institutes of Health, among other organizations.
The authors are solely responsible for the content of the publication, which does not necessarily represent the official views of the NIH or its funding partners.
Source: ScienceDaily