Pancreatic Cancer
PanaSee™
Pancreatic cancer patients are typically diagnosed with late-stage disease after the appearance of symptoms, which is a major contributing factor to poor prognosis and the high mortality rate. A simple blood test that identifies a small proportion of the general population with increased risk of pancreatic cancer represents an excellent opportunity for catching the disease early – when treatment is the most effective.
PanaSee™ is a blood test for determining the risk of pancreatic cancer. PanaSee measures the concentration of a long-chain fatty acid, called PC-594, in the blood. If the PC-594 level is below a certain threshold, then a person’s risk of pancreatic cancer is increased.
Subjects with a positive PanaSee test have an increased risk of pancreatic cancer, and should speak with their physician about a surveillance program based on repeat PanaSee testing in combination with one or more types of medical imaging.
If you want to learn more about PanaSee, have questions, or would like to obtain information materials for use in your office or distribution to your patients or clients, please contact us.
The PanaSee™ test is intended for use in risk assessment and monitoring; it is not a standalone diagnostic test, and is not a screening test for pancreatic cancer.
PanaSee™ Clinical Studies
Our path to discovery of PC-594 and the clinical story of developing our PanaSee™ test:
Initial metabolomics discovery
In our discovery study, which included blood samples from 40 pre-treatment Japanese pancreatic cancer patients and 50 controls (Osaka, Japan), we used non-targeted metabolomics technology based on high resolution mass spectrometry to discover a reduction in the circulating levels of metabolites belonging to several different metabolic systems. Statistical modelling identified a 36 carbon long-chain fatty acid, called PC-594, as the single best discriminating metabolite. The receiver-operator characteristic curve area (ROC-AUC) for pancreatic cancer was 0.96 (95% CI 0.94-0.98).
Validation 1 in Japanese patients
In this study, we used the first-generation PanaSee™ test to validate a PC-594 reduction in 122 Japanese pancreatic cancer patients compared to 138 healthy controls (Osaka University). The study also included samples from 38 patients with intraductal papillary mucinous neoplasia (IPMN). The ROC-AUC for pancreatic cancer was 0.93 (95% CI 0.91-0.95).
Validation 2 in Japanese patients
In this study, we further validated a reduction of PC-594 in 64 Japanese pancreatic patients compared to 140 controls (in collaboration with Chiba University), and investigated the effect of surgery on PC-594 levels. PC-594 levels were not restored following surgery, suggesting their reduction is a prodromal effect and not the result of the tumor. The ROC-AUC for pancreatic cancer was 0.99 (95% CI 0.98-1.0).
Validation 1 in North American patients
We performed a study in 20 North American patients, 14 with pancreatic cancer and 6 with intraductal papillary mucinous neoplasia, and 1040 controls aged 30 to 80 to determine a population distribution and cut-off. The ROC-AUC for pancreatic cancer was 0.97 (95% CI 0.96-0.98).
Validation 2 in North American patients
This study investigated PC-594 levels in an independent North American population, and compared the results to CA19-9. The study included 84 pancreatic cancer patients and 99 cancer-free controls. The ROC-AUC for pancreatic cancer patients was 0.91. In comparison, CA19-9 levels showed an ROC-AUC of .85. This study confirmed that an abnormally low PC-594 fatty acid level is a significant risk factor for pancreatic cancer, and is superior to CA19-9 as an indicator of risk.
The PanaSee™ test is intended for use in risk assessment and monitoring; it is not a standalone diagnostic test, and is not a screening test for pancreatic cancer.