Pancreatic cancer is one of the most deadly and difficult to detect and diagnose cancers, as the signs and symptoms are similar to many other diseases. There are more than 40,000 deaths and over 50,000 new cases diagnosed each year in the U.S. alone, and the five-year survival rate for pancreatic cancer is currently 4-6%. It is predicted to become the second leading cause of cancer death by 2020. Early detection is, however, the key to significantly improving pancreatic cancer patients’ 5-year survival rates from 4-6% to potentially 50-60%.
Several different PDAC biomarkers are used in the clinical practice worldwide, including C-reactive protein (CRP), CA 242, GDF-15, haptoglobin, M2-pyruvate kinase, serum amyloid A, platelet factor 4, and IGF-binding protein (IGFBP)-1. However, none of them has proven to be clinically superior to CA 19-9, the most common PDAC biomarker today. Nevertheless, the clinical utility of CA 19-9 is disputed as it has been found to be elevated in both non-malignant conditions (e.g. pancreatitis and acute cholangitis) and other gastrointestinal cancers (e.g. gastric cancer and colorectal cancer), and thus is not PDAC specific. Moreover, CA 19-9 may be absent in about 10% of the population, as some genotypic subjects cannot produce the CA 19-9 epitope. As a result, CA 19-9 has yielded a moderate sensitivity (69% -98%; 83,5% on avg.) and specificity (46%–98%; 72% on avg.) when screening for PDAC. Given the limitations of the biomarkers, PDAC diagnostics relies today heavily on other methods, such as biopsy, CT, MRI, EUS, PET, MRCP or ERCP. However, those are not designed to detect PDAC in its early stages and require access to expensive and specialized diagnostic facilities. As a result, those methods should be considered as the secondary diagnostic tools, enabling more precise diagnosis once the presence of PDAC in the patient’s organism has been confirmed by a biomarker.
IMMUNOVIA’S PROGRESS BEYOND THE STATE-OF-THE -ART
In the course of the project, Immunovia has already conducted the largest ever studies for diagnosing pancreatic cancer that pave way for early intervention to significantly improve survival rates.
The IMMray™ PanCan-d test is able to differentiate with 96% accuracy patients with early resectable stages of pancreatic cancer, stage I and II, from the healthy controls. When analysing all stages of pancreatic cancer, the accuracy of Immunovia´s test is reported as high as 98%.
Our biomarker signature is highly specific and sensitive for stage I, II, III, and IV patients. The results from the studies performed to date are extremely encouraging, especially due to the large number of early stage patient samples. These results clearly show that our biomarker signature is able to detect the early stage patients when the cancer is still resectable by surgical methods. IMMray™ PanCan-d detected pancreatic cancer with an unprecedented 96% accuracy in early stages of the disease, stages I and II and with 98% accuracy for all stages I-IV. Until now, the studies covered more than 3000 patient samples from Europe, US, and Japan. We now have a strong confirmation that IMMray™ PanCan-d is able to detect pancreatic cancer in all stages, even in stage I and II.
