Innovative pancreatic cancer blood test approaches patient availability
An experimental blood test for pancreatic cancer is currently under evaluation by a commercial laboratory, marking an important step towards clinical use.
Scientists from the Van Andel Institute (MI, USA) and the University of Pittsburgh (PA, USA) have developed an experimental blood test for pancreatic cancer, which significantly outperforms the current gold standard test. The test has recently reached a key milestone as it undergoes testing in a commercial laboratory, an essential march of progress towards patient availability.
According to the World Health Organization (Geneva, Switzerland), pancreatic cancer is one of the leading causes of cancer death worldwide, claiming approximately 500,000 lives in 2022. Although early diagnosis is crucial for a better prognosis, pancreatic cancer is particularly difficult to detect. This is mostly due to its asymptomatic nature during early stages, meaning patients are usually diagnosed when the disease has metastasized. As such, there is an urgent need for new tests that can detect pancreatic cancer earlier.
The double-blinded study, which was recently published in the journal Cancer Letters, demonstrated that the new test accurately identified 71% of pancreatic cancer samples in laboratory settings, outclassing the currently used gold-standard test – which correctly identified only 44% – by 27%. The blood test also significantly reduced any unwanted false negatives while maintaining a low false positive rate, ensuring the test’s accuracy in correctly determining whether cancer is present or absent.
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Before doctors can begin using the test for cancer diagnosis, it must first complete clinical validation to certify lab quality. This requires a CLIA-accredited diagnostics laboratory adapting the experimental version of the test into a reliable test suitable for use under the stringent conditions found in a clinical setting.
“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,” explained Dr Brian Haab, lead author and Professor at the Van Andel Institute.
The new blood test works by detecting the presence of two sugar molecules, CA199.STRA and CA19-9, which are both released into the bloodstream by pancreatic cancer cells. CA19-9 is the current gold-standard biomarker for pancreatic cancer, while CA199.STRA was recently identified as an additional cancer biomarker by Dr Haab’s laboratory.
ReligenDx, a CLIA-accredited diagnostic laboratory in Pennsylvania, will conduct the clinical validation of the new test; it is expected that the process will take 2 years. If clinical validation proves successful, Dr Haab predicts two primary uses for the test: enabling earlier detection of pancreatic cancer in high-risk individuals, and monitoring cancer progression and treatment response in patients already diagnosed with pancreatic cancer.
