BlueCross BlueShield of Tennessee Medical Policy Manual

Molecular Anatomic Pathology Testing (PathFinderTG®)

DESCRIPTION

Tests that integrate microscopic analysis with molecular tissue analysis 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

See also:  Expanded Molecular Panel Testing of Cancers to Identify Targeted Therapies

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/practice/medical-position-statements/Barretts_MPS.pdf.

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/article/S0016-5085(15)00100-6/pdf.

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2016). PathFinderTG® molecular testing (02.04.52). Retrieved May 4, 2017 from BlueWeb. (53 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Genetic Test Evaluation (GTE) Report. (2016, November). PancraGEN (Interpace Diagnostics). Retrieved May 4, 2017 from www.Hayesinc.com/subscribers. (31 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  8/14/2010

MOST RECENT REVIEW DATE:  6/8/2017

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