Michelle Springer, MS, CGC - CGA-IGC Communication Committee
As part of an ongoing partnership between CGA-IGC and the Journal of Clinical Oncology-Precision Oncology to showcase cutting-edge research via simultaneous publication with oral plenary presentations, Dr. Bryson Katona discussed outcomes of the IMMray PanCan-d test in high-risk individuals undergoing pancreatic cancer (PC) surveillance. IMMray’s PanCan-d test, which combines 8 biomarkers and CA19-9, was the first pancreatic cancer-specific blood test to be offered commercially. It was available from August 2021 to July 2023, and initial data from validation studies showed a very promising sensitivity of 92% and specificity of 99% for pancreatic cancer detection.
Dr. Katona presented data from his work, a blinded spike-in study, which looked at the outcomes of the PanCan-d test in clinical practice. His study assessed the performance characteristics of 100 clinical IMMray PanCan-d tests on 94 high-risk individuals undergoing PC surveillance and 6 individuals with a known PC diagnosis. Testing was done 1-2 months prior to imaging and possible test results included positive, negative, borderline, and not performed due to low CA19-9 expression. PanCan-d results in the high-risk cohort included 1 positive, 7 borderline, 73 negative, and 13 not performed. None of these individuals were diagnosed with PC on their surveillance examination; however other findings in this group included PNET (n=2), indeterminate mass (n=1), and >1 cyst, most consistent with IPMN (n=25). In the cohort of individuals known to have pancreatic cancer, there were 4 positive results and 2 negative results. In all, the negative predictive value (NPV) of the IMMray PanCan-d test was >99%, while the positive predictive value (PPV) was 35-52% (when borderline results were not included as a positive) or 12% (when borderline results were considered a positive test result).
The development of blood-based tests that allow for early detection of pancreatic cancer is crucial, as studies have shown that surveillance in high-risk individuals can downstage PC diagnosis and improve survival. While IMMray’s PanCan-d test had a robust NPP of >99%, the PPV was suboptimal, ranging from 12-52% (depending on whether borderline results were included as a positive or negative). Important considerations for future development of these tests include eliminating a borderline test result and developing an assay that does not include, or can be run independently of, CA19-9.
Many thanks to Dr. Katona for sharing his data on the first PC-specific blood test to be tested in a clinical setting!
This study was concurrently published online in JCO Precision Oncology on October 26th, 2023.