miRInform™ Pancreas FFPE

Pancreatic cancer is the fourth leading cause of cancer-related deaths in the US, with a 5-year survival rate lower than 5%. Pancreatic ductal adenocarcinoma (PDAC) accounts for >90% cases of pancreatic cancer (link to ACS).

Differentiation between a benign condition of chronic pancreatitis and pancreatic cancer is often difficult, as both conditions may present with the similar symptoms (abdominal pain, weight loss, jaundice) and are not mutually exclusive. Additionally, chronic pancreatitis specimens share many of the histopathological and imaging features of pancreatic cancer both microscopically and during preoperative imaging studies².

Inaccurate diagnosis can lead to major surgery for benign disease or delay of surgery for a potentially curable lesion. Because of these adverse clinical consequences, there is considerable subjectivity in the final call which has been reported to have up to a 20% error rate³∙⁴.

The test is based on an RT-qPCR analysis of the raw expression difference (ΔCT) between 2 gene products, miR-196a and miR-217. This miRNA signature is a balanced set wherein, one gene product is expected to be up-regulated in pancreatic ductal adenocarcinoma (miR-196a), while the other is expected to be down-regulated (miR-217), as compared to normal pancreas and chronic pancreatitis tissue¹.

A blinded validation study on FFPE specimens using a threshold value of 0.5 ΔCT resulted in analytical sensitivity of 95.2% (95%CI: 77.3- 99.2) and analytical specificity of 94.9% (95%CI: 83.1- 98.6).

• At least three (3)10 µm FFPE tissue sections containing ≥60% abnormal area content. Include one (1) H&E stained slide.

• Five (5) to eight (8) unstained slides with 5 µm tissue sections containing ≥60% abnormal area content. Include one (1) H&E stained slide.

• FFPE clinical blocks containing ≥60% abnormal area.

• For specimens with <60% abnormal area content, Asuragen’s in-house pathologists will determine if the specimen abnormal area content can be enriched.

Asuragen bills third parties (private insurance and Medicare), patients, and hospitals.

Note: Asuragen does not accept Medicaid. Asuragen cannot accept samples from New York or Florida at this time.

For additional billing information, please contact Clinical Laboratory Support: Phone: 888-772-8018 Email: ClinicalLabSupport@asuragen.com

Results can be expected within 8-10 business days from the date the sample is received.