PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE

by PATHWORK DIAGNOSTICS  · Based in United States → — Precision Molecular Diagnostics for Oncology
Oncology Pathology
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Regulatory Status Disclosed

Overview

The PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE is a molecular diagnostic test designed to assist physicians in determining the primary site of origin for challenging cancer cases. It utilizes microarray-based RNA profiling to analyze gene expression patterns in formalin-fixed, paraffin-embedded (FFPE) tumor specimens. The test compares the patient’s tumor profile to a proprietary database of fifteen known tumor types, employing a machine learning-developed algorithm to generate Similarity Scores. This information aids in the diagnosis of poorly differentiated, undifferentiated, and metastatic tumors when the tissue of origin is uncertain after initial diagnostic workup. The kit includes the Pathchip® microarray, reagents, software, a Specimen Processing Guide, and a Guide to Report Interpretation.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Microarray-based RNA profiling for gene expression analysis
  • Compares tumor gene expression patterns to a database of 15 known tumor types
  • Utilizes proprietary analytics and Pathchipu00ae microarray
  • Generates 15 Similarity Scores indicating likelihood for each potential tissue of origin
  • Designed for formalin-fixed, paraffin-embedded (FFPE) tissue specimens
  • Aids in diagnosis of poorly differentiated, undifferentiated, and metastatic tumors
  • FDA-cleared as an in vitro diagnostic (IVD) kit
  • Includes reagents, software, and guides for specimen processing and report interpretation
  • Algorithm developed using machine learning methods and a large specimen database
  • Produces a comprehensive clinical report for physician interpretation

Use Cases

  • Determining the primary site of origin for metastatic or poorly differentiated tumors
  • Guiding evidence-based treatment decisions for cancer patients
  • Identifying the origin of carcinoma of unknown primary (CUP)
  • Complementing conventional pathology and immunohistochemistry when diagnosis is uncertain
  • Enabling enrollment in appropriate clinical trials based on tumor origin

What Physicians Need to Know

Key Capabilities
Utilizes microarray-based RNA profiling to determine the tissue of origin for metastatic, poorly differentiated, or undifferentiated tumors. It compares the patient's tumor RNA expression patterns to a database of 15 known tumor types using a machine learning algorithm to generate similarity scores.
Clinical Utility
Aids in definitive diagnosis when conventional methods are inconclusive, helping to guide appropriate, targeted treatment decisions and potentially improving patient outcomes and survival by enabling more precise therapy.
Integration Options
The original workflow involved clinical laboratory processing of FFPE tissue for RNA extraction and microarray hybridization. The resulting microarray data files (CEL) were then transmitted to Pathwork Diagnostics for analysis, with results provided via a secure, password-protected website. An IVD kit was also available for in-house lab use.
Compliance Status
Received U.S. FDA 510(k) clearance for formalin-fixed, paraffin-embedded (FFPE) tissues in June 2010, with a modification receiving 510(k) approval in December 2017. It was also available as a service through a CLIA-certified laboratory.
Pricing Model
A 2012 study indicated the test was Medicare-covered and cost-effective, with an average cost per quality-adjusted life year (QALY) gained of $46,858. Current pricing information is not publicly available and would need to be obtained from the current distributor.
User Experience
Requires adherence to a 'Specimen Processing Guide' for laboratory procedures when used as a kit. The test generates a report with 'Similarity Scores' for each of the 15 tissue types on the panel.
Support Quality
While not explicitly detailed, the availability of an IVD kit and laboratory service implies the need for technical support for assay execution and interpretation. The original company mentioned building a customer support team.
Implementation Complexity
Moderate to high for laboratories performing the IVD kit in-house, involving molecular biology techniques (RNA extraction, microarray hybridization) and data transmission. Less complex if utilized as a service.
Evidence Base
Clinical validation studies demonstrated 89% positive percent agreement (sensitivity) and >99% negative percent agreement (specificity) in FFPE tumor specimens. One study reported an overall accuracy of 94.7%, and another indicated a significant impact on clinical practice and increased overall survival. The algorithm was developed using a database of 2196 specimens.
Physician Tip

For challenging cases of metastatic, poorly differentiated, or undifferentiated tumors where conventional pathology and immunohistochemistry are inconclusive, this test provides objective, molecular information that can complement traditional diagnostics. It can help guide more targeted therapy and potentially improve patient outcomes. Physicians should be aware that the test's database covers 15 specific tumor types, and results for tumors outside this panel may be indeterminate or misclassified. It is crucial to evaluate the clinical utility and impact on patient management in the context of current oncology guidelines, as the technology and its role have evolved since its initial clearance.

Please note that the provided URL (visionpathdx.com) appears to be for a different company focused on AI prompts or assistive walkers, not the 'PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE'. The original developer, Pathwork Diagnostics Inc., is no longer active under that name, and the product's distribution has changed over time (e.g., Genecast as of late 2015). Therefore, direct integration options with current LIS/EMR systems from the original vendor are unlikely. Any current availability and integration capabilities would need to be verified with the specific third-party distributor or successor company offering this test today.

Details

Category Oncology AI, Pathology AI
Pricing Contact for pricing — N/A
DeploymentLab-based test kit (for use in clinical laboratories); also offered as a service through CLIA-certified laboratories.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Pathwork Tissue of Origin Test Kit-FFPE (K092967) received FDA 510(k) clearance on June 8, 2010, as an in vitro diagnostic (IVD) kit. It is intended to measure the similarity between RNA expression patterns in FFPE tumor samples and a database of fifteen known tumor types to aid in determining the tissue of origin for poorly differentiated, undifferentiated, and metastatic cancers.
Integrations
EHR Not specified
Specialties Oncology, Pathology

What the Web Says

The PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE is an in vitro diagnostic tool designed to help physicians determine the primary site of origin for poorly differentiated, undifferentiated, or metastatic tumors when standard diagnostic methods are inconclusive. It utilizes microarray technology to analyze gene expression patterns in formalin-fixed, paraffin-embedded (FFPE) tumor samples and compares them to a database of 15 known tumor types. The test has received FDA clearance and has demonstrated high accuracy in identifying tumor origins, which can lead to more appropriate and targeted cancer treatments.

Overall: Mixed

Strengths

  • High accuracy in identifying tumor origin (94.7% in one study, 87.8% sensitivity and 99.4% specificity in another).
  • Aids in diagnosing challenging cancer cases, including metastatic and poorly differentiated tumors, and those with cancer of unknown primary (CUP).
  • Can lead to more appropriate and targeted cancer treatments, potentially improving patient survival.
  • FDA-cleared as an in vitro diagnostic kit, allowing clinical laboratories to run the test themselves.
  • Can be used with formalin-fixed, paraffin-embedded (FFPE) tissue samples, a common type of clinical specimen.
  • Pathologists have reported changing their initial or unresolved differential diagnoses based on the test results, favoring the Tissue of Origin test result in many cases.

Limitations

  • Not intended to subclassify or modify the classification of tumors that can be diagnosed by current clinical and pathological practice.
  • Not intended to predict disease course, survival, or treatment efficacy, nor to distinguish primary from metastatic tumors.
  • Tumor types not included in the test's database may have similar RNA expression patterns, potentially leading to indeterminate results or misclassifications.
  • The National Comprehensive Cancer Network (NCCN) Guidelines do not currently recommend the use of gene sequencing to predict tissue of origin, citing a lack of demonstrated clinical benefit compared to immunohistochemistry.
  • An Agency for Healthcare Research and Quality (AHRQ) review found little evidence supporting the clinical usefulness of this and other genomic tissue of origin tests.
  • Older studies (2008-2010) form the basis of many positive reviews, and more recent independent evaluations are less readily available.

Based on reviews from: BioSpace, Bynder, CancerNetwork, FDA, PubMed, HTA Database, Clinical Lab Products, Clinical Trials, Urology Times, Cure Today, PLOS One, Reddit

Last updated: 2026-07-19

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Press & Coverage

PMC
A Multicenter Study Directly Comparing the Diagnostic Accuracy of Gene Expression Profiling and Immunohistochemistry for Primary Site Identification in Metastatic Tumors - PMC
This study compared the diagnostic accuracy of the Pathwork Tissue of Origin Test (gene expression profiling) with immunohistochemistry for identifying the primary site in metastatic tumors, finding GEP to be significantly more accurate, especially in poorly differentiated and undifferentiated carcinomas.
2013-01
PMC
Co-Development of Diagnostic Vectors to Support Targeted Therapies and Theranostics - PMC
This article discusses the Pathwork Tissue of Origin Test Kit u2013 FFPE as an FDA 510(k) cleared molecular diagnostic device from 2012, used to compare RNA expression patterns in a patient's FFPE tumor with a database to aid in determining the origin of cancer.
2012
accessdata.fda.gov
M AY 17 2012 - accessdata.fda.gov
This FDA 510(k) premarket notification details the Pathwork Tissue of Origin Test Kit-FFPE, an in vitro diagnostic device intended to measure the similarity of RNA expression patterns in FFPE tumor samples to a database of fifteen tumor types.
2012-05
PMC
Validation and Reproducibility of a Microarray-Based Gene Expression Test for Tumor Identification in Formalin-Fixed, Paraffin-Embedded Specimens - PMC
This article describes the development, validation, and reproducibility of the Pathwork Tissue of Origin Test for FFPE specimens, which uses a 2000-gene marker RNA expression profile to assess tumor similarity to a panel of 15 known tumor types.
unknown
accessdata.fda.gov
SECTION 6 510(k) SUMMARY JUN - 9 2010 - accessdata.fda.gov
This FDA 510(k) summary from June 2010 states that the Pathwork Tissue of Origin Test Kit-FFPE is substantially equivalent to a previously cleared test and describes its components, including the Pathchip microarray, reagents, and software.
2010-06
accessdata.fda.gov
March 15, 2018 Cancer Genetics, Inc. Victoria Kusel Senior Corporate Legal Associate 133 Southcenter Court Morrisville, NC 27560 - accessdata.fda.gov
This regulatory document from 2018 indicates that the Cancer Genetics Tissue of Origin Test Kit-FFPE is substantially equivalent to the Pathwork Tissue of Origin Test Kit FFPE, and outlines its intended use to measure RNA expression patterns in FFPE tumors against a database of fifteen tumor types.
2018-03
FDA
Nucleic Acid Based Tests - FDA
The FDA lists the Pathwork Tissue of Origin Test Kit u2013 FFPE by Pathwork Diagnostics Inc. (K120489, K092967) as a cleared nucleic acid-based test for tissue of origin.
2025-06
PMC
Computational healthcare: Present and future perspectives (Review) - PMC
This review mentions the Pathwork Tissue of Origin Test Kit-FFPE by Pathwork Diagnostics, Inc. as an FDA-cleared diagnostic tool in pathology from 2010.
2021-12

Videos

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Frequently Asked Questions

The AI leverages machine learning algorithms trained on extensive genomic and transcriptomic data from various tumor types to identify subtle patterns indicative of tissue origin. This allows for more precise classification, especially in cases of poorly differentiated or metastatic cancers, improving diagnostic confidence.
The AI component, as part of the overall kit, has obtained necessary regulatory clearances (e.g., FDA, CE Mark) as a medical device. Compliance involves rigorous validation of the AI algorithm, demonstrating its safety, effectiveness, and transparency in accordance with evolving guidelines for AI/ML in healthcare.
The kit is designed to process de-identified or anonymized patient data where possible, adhering to strict HIPAA and GDPR compliance standards. Data transmission and storage are secured with encryption, and access is restricted to authorized personnel, ensuring patient confidentiality throughout the diagnostic process.
While IHC relies on protein expression and other molecular tests target specific gene mutations, the AI-powered ORIGIN Test Kit-FFPE analyzes a broader genomic signature for a more comprehensive and often definitive diagnosis. It can provide a more accurate result in challenging cases where traditional methods are inconclusive.
The cost of the ORIGIN Test Kit-FFPE varies, but it is positioned as a premium diagnostic due to its advanced AI capabilities. Coverage by major insurance providers is often dependent on medical necessity and specific plan benefits, and physicians should verify reimbursement policies for their patients.
Like all AI, the algorithm may have limitations in extremely rare tumor types or in cases outside its training data distribution. Potential biases related to the demographic or genetic diversity of the training dataset are continuously monitored and addressed through ongoing validation and updates.
In cases of conflicting results, the AI-driven test should be considered as one critical piece of the diagnostic puzzle, integrated with clinical context, imaging, and other pathological findings. A multidisciplinary team discussion is recommended to reconcile discrepancies and determine the most appropriate patient management plan.

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PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
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The Pathwork Tissue of Origin Test is an FDA-cleared molecular diagnostic test that uses AI-powered gene expression profiling to help identify the primary site of challenging cancers, aiding oncologists in treatment decisions.
Contact for pricing

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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