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The testing involves the following steps:

• manual microdissection to identify and procure abnormal cells from existing pathology specimens
• DNA extraction and amplification (e.g., polymerase chain reaction [PCR])
• DNA sequencing to identify oncogenic mutations
• integrating this molecular information with the cytologic or histologic findings provided by the pathologist of record to provide a definitive diagnosis

For some specimens such as fluid aspirates, DNA is extracted from the fluid, since there may be little or no cellular content. The molecular testing consists of applying panels of molecular markers previously defined for each organ system or clinical question.

Potential uses described by the company include determining reactive versus neoplastic lesions, benign versus malignant lesions, biologically indolent versus aggressive tumors, which premalignant lesions will or will not progress into cancer, whether a synchronous or metachronous tumor represents metastatic spread or a new primary, and expected responses to treatment for various tumors. RedPath proposes that PathFinderTG® is appropriate in clinical practice when the results will alter clinical decision-making.

Some of the tests RedPath offers (e.g., 1p/19q loss, microsatellite instability) are offered by other laboratories as single clinical tests. The remainder of the tests they offer (e.g., KRAS point mutation and loss-of-heterozygosity [LOH] panels) are typically performed in research settings.  The aim of PathFinderTG® testing is to integrate molecular findings into the pathology diagnosis.

This patented diagnostic test is available only through RedPath Integrated Pathology (Pittsburgh, PA). The PathFinderTG® Molecular Testing is not subject to review by the U.S. Food and Drug Administration (FDA) because it is a laboratory-developed test (LDT) conducted only at RedPath Integrated Pathology’s licensed laboratory. Laboratories performing LDTs must be licensed for high-complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). RedPath is licensed under CLIA.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

7/17/2008: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)

4/27/2009: Policy reviewed, no changes

07/09/2010:  Policy description revised to define PCR as "polymerase chain reaction."  Policy statement unchanged. 

08/02/2011: Policy reviewed; no changes.

07/17/2012: Policy reviewed; no changes.

All codes billed for this procedure are considered investigational and not eligible for coverage. 

Non-Covered Codes