miRInform™ Pancreas for FNAs

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 may coexist. Additionally, chronic pancreatitis specimens share many of the histopathological and imaging features of pancreatic cancer both microscopically and during preoperative imaging studies²∙³.

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 leads to a significant number of indeterminate diagnoses and a 30% false negative rate⁴.

miRNAs are short, non-coding single stranded RNAs that regulate gene expression by partial base pairing with the miRNA recognition sites found in their messenger RNA (mRNA) targets. This interaction can cause repression of mRNA translation or mRNA cleavage. It is estimated that approximately 30% of protein coding genes are regulated by miRNAs. By regulating protein expression, miRNAs affect many crucial cellular processes including those of early development, cell proliferation, cell cycle, apoptosis and metabolism. Alteration of miRNA expression patterns are linked to many diseases, including pancreatic cancer, due to the tumor suppressor role miRNAs can play.

The performance of miRInform™ Pancreas is optimized when the Test is used in conjuntion with traditional FNA cytopathology. In particular, miRInform™ Pancreas is recommended for the clarification of indeterminate, atypical and suspicious cytopathology results. Additionally, data from the validation study suggest that miRInform™ Pancreas may be used to lower false negative cytopathology rates when the Test is ordered as a reflex to benign cytopathology results.

miRInform™ Pancreas was developed and validated through a large multi-center collaboration involving a total of 186 patients enrolled at University of Pittsburgh Medical Center, Brigham and Women’s Hospital, University of Sherbrooke (Canada), Moffitt Cancer Center & Research Institute, Silesian Medical University (Poland), Hospital of the Ministry of Internal Affairs and Administration, Medical University of Łódź (Poland), Dartmouth Hitchcock Medical Center and Rühr University of Bochum (Germany). The Test measures the expression levels of seven miRNAs via reverse transcription quantitative polymerase chain reaction (RT-qPCR) analysis.

To determine if the patient sample is benign or PDAC, a proprietary algorithm is applied to the expression levels of the seven miRNAs and a score between 0 and 1 (inclusive) is generated. A score less than 0.5 is considered benign and a score between 0.5 and 1 is considered to be PDAC.

The results of the validation for miRInform™ Pancreas are shown below.

miRInform™ Pancreas is intended to be used in conjunction with indeterminate and benign FNA cytopathology. miRInform Pancreas can help resolve indeterminates, including those considered atypical or suspicious. Additionally, the Test can be used as a safeguard against false negative cytopathology which may occur up to 30% of the time¹. The performance of miRInform™ Pancreas was established by comparison of the combined FNA cytolpathology and miRInform™ Pancreas results with final diagnoses.

• A single FNA pass expressed from a 20-25 gauge needle into a provided vial of RNA Retain®. The specimen may be kept at room temperature for up to two hours after collection. Specimens may be kept overnight at 4ºC but specimens stored longer than overnight should be kept at -20ºC. Specimens should be shipped to Asuragen on ice packs.

Note: This Test has been validated on solid masses. It has not been validated on cystic fluid specimens.

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.