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DESCRIPTIONThe patented PathFinderTG® test is a molecular test to be used adjunctively in cases in which a definitive pathologic diagnosis cannot be rendered on a tissue or cytology specimen, either due to inadequate specimen or equivocal histologic or cytologic findings. This approach may be referred to as “molecular anatomic pathology.” RedPath, the test provider, suggests that the PathFinderTG® results provide useful and definitive diagnostic and prognostic information and reliably predict treatment response for multiple organ systems.
The testing involves the following steps:
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.
POLICYMolecular testing using the PathFinderTG® system is considered investigational for all indications including the evaluation of pancreatic cyst fluid and of suspected or known gliomas.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY4/29/2008: Policy added
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.
08/14/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 2.04.52
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.