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.
Molecular anatomic pathology (e.g., PancraGEN or BarreGEN) testing for all indications, including, but not limited to the evaluation of pancreatic cyst fluid, Barrett esophagus and solid pancreaticobiliary lesions is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
No evidence of any kind is available to indicate whether molecular anatomic pathology testing improves patient outcomes.
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
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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