BlueCross BlueShield of Tennessee Medical Policy Manual

Molecular Anatomic Pathology Testing (PathFinderTG®)

DESCRIPTION

Molecular anatomic pathology tests integrate microscopic analysis with molecular tissue analysis and are generally called topographic genotyping. Interpace Diagnostics offers two such tests that use the PathFinderTG® platform (e.g., PancraGEN, BarreGEN). These molecular tests are intended to be used adjunctively when a definitive pathologic diagnosis cannot be made due to inadequate specimen or equivocal histologic or cytologic findings. Under microscopic examination of tissue and other specimens, areas of interest may be identified and microdissected to increase tumor cell yield for subsequent molecular analysis. Topographic genotyping is proposed as a method to permit pathologic diagnosis when first-line analyses are inconclusive.

PancraGEN is marketed for use in diagnosing cancer in individuals with pancreatic cysts, while BarreGEN is marked for individuals with Barrett esophagus.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

No evidence of any kind is available to indicate whether molecular anatomic pathology testing improves patient outcomes.

SOURCES

American Gastroenterological Association. (2011). American Gastroenterological Association medical position statement on the management of Barrett’s esophagus. Retrieved May 4, 2017 from http://www.gastro.org.

American Gastroenterological Association. (2015). American Gastroenterological Association Institute guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts. Retrieved May 4, 2017 from http://www.gastrojournal.org.

Arner, D.M., Corning, E.B., Ahmed, A.M., Ho, H.C., Weinbaum, B.J., Siddiqui, U., et al. (2018). Molecular analysis of pancreatic cyst fluid changes clinical management.Endoscopic Ultrasound, 7 (1), 29-33. (Level 4 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (10:2018). Molecular testing for the management of pancreatic cyst or barrett esophagus (02.04.52). Retrieved March 1, 2019 from https://www.evidencepositioningsystem.com/. (57 articles and/or guidelines reviewed)

National Comprehensive Cancer Network. (2018, December). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Hepatobiliary Cancers. Retrieved March 4, 2019 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2018, May). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Esophageal and esophagogastric junction cancers. Retrieved March 4, 2019 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2018, November). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Pancreatic adenocarcinoma. Retrieved March 4, 2019 from the National Comprehensive Cancer Network.

ORIGINAL EFFECTIVE DATE:  8/14/2010

MOST RECENT REVIEW DATE:  3/28/2019

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