TISSUE OF ORIGIN TEST KIT FFPE
Overview
The Pathwork Tissue of Origin Test Kit-FFPE is an in vitro diagnostic test, not an AI tool for a physician directory. It is designed to assist physicians in determining the tissue of origin for challenging tumors, including poorly differentiated, undifferentiated, and metastatic cases. The test utilizes microarray-based RNA profiling to measure the degree of similarity between the RNA expression patterns in a patient’s formalin-fixed, paraffin-embedded (FFPE) tumor specimen and a proprietary database of 15 known tumor types. The underlying algorithm for this test was developed using machine learning methods to build a predictive model. The results provide objective, probability-based similarity scores, which, when evaluated by a qualified physician in the context of the patient’s clinical history and other diagnostic results, can guide more appropriate, targeted cancer treatment.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Microarray-based RNA profiling for tumor analysis
- Compares tumor RNA expression patterns to a database of 15 known tumor types
- Utilizes formalin-fixed, paraffin-embedded (FFPE) tissue specimens
- Aids in diagnosing poorly differentiated, undifferentiated, and metastatic tumors
- Provides objective, probability-based similarity scores for tissue identification
- FDA-cleared as an in vitro diagnostic kit
- Algorithm developed using machine learning methods
Use Cases
- Determining the tissue of origin for tumors with uncertain primary sites
- Guiding appropriate, targeted cancer treatment based on identified origin
- Complementing existing diagnostic technologies such as immunohistochemistry
Details
| Category | Oncology AI, Pathology AI |
| Pricing | Unknown |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The Pathwork Tissue of Origin Test Kit-FFPE received FDA 510(k) clearance (K120489) on May 17, 2012. It is an in vitro diagnostic intended to measure RNA expression patterns to aid in identifying the tissue of origin for poorly differentiated, undifferentiated, and metastatic tumors. The test's algorithm was developed using machine learning methods. |
| Integrations | |
| EHR | Not specified |
| Specialties | Laboratory Medicine, Oncology, Pathology |
What the Web Says
The Pathwork Tissue of Origin Test Kit-FFPE is a molecular diagnostic tool designed to help identify the primary site of metastatic or poorly differentiated tumors when the origin is unknown. It works by comparing the RNA expression patterns in a patient's formalin-fixed, paraffin-embedded (FFPE) tumor sample to a database of known tumor types. The test was cleared by the FDA through the 510(k) process in 2010, with minor modifications cleared in 2012.
Overall: MixedStrengths
- Can be used with FFPE tissue, which is standard for pathology material.
- Demonstrated higher accuracy in identifying primary tumor sites compared to immunohistochemistry (IHC) in some studies, particularly for poorly differentiated and undifferentiated tumors.
- Provides a similarity score for 15 different tissue types, indicating the likely tissue of origin.
- Can effectively rule out specific tissue types as the origin if similarity scores are low.
- Aids in determining the origin of cancer, which can help guide treatment decisions.
Limitations
- Gene expression profiling for this indication is considered investigational by some medical policies, and a clinical benefit has not always been demonstrated.
- Tumor types not included in the test's database may lead to indeterminate results or misclassifications.
- Performance has not been established for results where the highest similarity score is less than 20.
- Formalin fixation can degrade RNA, potentially affecting accuracy with microarray technology, although the FFPE kit is designed to address this.
- The National Comprehensive Cancer Network (NCCN) guidelines do not currently recommend the use of gene sequencing to predict tissue of origin, stating that while there may be a diagnostic benefit, a clinical benefit has not been demonstrated.
Based on reviews from: accessdata.fda.gov, AAPC, Frontiers, Horizon Blue Cross Blue Shield of New Jersey, Innolitics, BCBSM, Bynder, PMC
Last updated: 2026-07-18
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