Test Data Show 90% Accuracy on Finding Pancreatic Cyst Malignancy

The numbers are in on studies of a new diagnostic called PancraGen’s ability to distinguish pancreatic malignancies from other findings in pancreatic cysts.

The test has 90% accuracy in stratifying patients for risk of pancreatic cancer with better accuracy than standard guideline-recommended tests alone, PDI Inc. announced at the American College of Gastroenterology Scientific meeting in Honolulu.

The data were presented in poster abstracts at the conference.

Under American College of Gastroenterology guideline criteria for managing cyst lesions, there is a less than 50% sensitivity for malignancy. As a result, many patients whose cysts are not indicative of cancer have unnecessary surgery. The test is a DNA-based molecular diagnostic that analyzes cyst fluid.

More than 120,000 such cysts are detected annually in the US usually with imaging studies of other organs that find them incidentally since the cysts are asymptomatic.

“All pancreatic cysts except those with clear cytological malignancy are ideal candidates for testing with PancraGen,” the company said.

Under other detection methodologies, up to 80% of surgeries on pancreatic cyst patients are potentially unnecessary, it noted. PDI, Inc is based in Parsippany, NJ. Interpace Diagnostics is a subsidiary of PDI.