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Houston, Texas

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Medical Genetics Test Details

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Pathwork Tissue of Origin Test
Test Information: The Pathwork Tissue of Origin Test is an FDA cleared in-vitro diagnostic intended to measure the degree of similarity between the RNA expression patterns in a patient's formalin fixed, paraffin embedded (FFPE) tumor and the RNA expression patterns in a database of fifteen tumor types (poorly differentiated, undifferentiated, and metastatic cases) that were diagnosed according to then current clinical and pathological practice. Results from this test should be evaluated by a qualified physician in the context of the patient's clinical history and other diagnostic test results.

The Pathwork Tissue of Origin Test is not intended to establish the origin of tumors (e.g. cancer of unknown primary) that cannot be diagnosed according to current clinical and pathological practice. It is not intended to subclassify or modify the classification of tumors that can be diagnosed by current clinical and pathological practice, nor to predict disease course or survival or treatment efficacy, nor to distinguish primary from metastatic tumor. Tumor types not in the Pathwork Tissue of Origin Test database may have RNA expression patterns that are similar to patterns in the database. Therefore, results cannot be used to distinguish tumor types in the database from tumor types not in the database.
Test Details
Test Code: 8070
Special Notes: This test is offered through the Cancer Genetics Laboratory (CGL, Medical Genetics Laboratories, Baylor College of Medicine, Houston, TX) pursuant to an agreement with Pathwork Diagnostics Inc. (Redwood City, CA). Sample evaluation, preparation (microdissection) and interpretation of results are performed by the CGL. Gene expression analysis (Tissue of Origin Test) is performed at the Pathwork Diagnostics laboratory.

Institutional, insurance or patient bill only. Medicare patients should submit specimens directly to Pathwork Diagnostics (www.pathworkdx.com).
Technical Information
Methodology: Specimens are sectioned and reviewed for tumor content and viability to ensure >60% tumor and <20% necrosis as per the Tissue of Origin Test guidelines. The tissue is microdissected from 10m sections and submitted to Pathwork Diagnostics (Redwood City, CA) for performance of the Tissue of Origin Test. At the Pathwork laboratory RNA is extracted and gene expression analysis is performed using the PathChip microarray. Gene Expression data are analyzed for similarity to 15 tissues of origins and reported as a similarity score using Pathwork Diagnostics algorithm.
Sample & Shipping Information
Test Requisition: Tumor Analysis
Specimen Type: FFPE - Slide(s)
Requirements: 1 H&E stained slide and 10 unstained 10um thick FFPE slides (non-charged, non-coated) containing adequate amounts of tumor to be analyzed**. Air dry. Do not oven dry. Please include a copy of corresponding surgical pathology report. Store specimen at room temperature (20-23.5C).

** Please contact the laboratory if less than 0.5 cm2 of tumor tissue is present on the selected slide/block.

Shipping Conditions: Ship at room temperature (20-25C) in an insulated container by overnight courier. Avoid extreme temperatures while shipping. Do not heat or freeze.

Specimen Type: FFPE - Tumor Block
Requirements: Paraffin-embedded, formalin-fixed tissue block. Please include a copy of corresponding surgical pathology report. Store specimen at room temperature (20-23.5C).

** Please contact the laboratory if less than 0.5 cm2 of tumor tissue is present on the selected slide/block.

Shipping Conditions: Ship at room temperature (20-25C) in an insulated container by overnight courier. Avoid extreme temperatures while shipping. Do not heat or freeze.

Turn Around Time: 14 days
Billing Information
List Price: $551.00 *Institutional discounts may apply, please call.
CPT Codes: 88381x1, 88386x1


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