Pathwork Tissue of Origin Test matched the known origin of most tumors

In FDA's review of the Pathwork Tissue of Origin Test, results agreed with the available diagnosis for 86.3% of metastatic and 92.0% of primary tumor specimens among 545.

  • Not rated an organization

    The study measured agreement with available diagnoses on processed specimens, and no change in diagnosis or treatment is reported.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

The available diagnosis for each specimen. Measured.

The system’s part
Not isolated. The study compared the test's results with the available diagnosis for each specimen. It did not compare diagnosis with and without the test.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

Download data Cite Suggest a correction

Benefit type
Improved Task Accuracy
System
Pathwork Tissue of Origin Test
Made by
Pathwork Diagnostics, Inc.
Used by
Pathwork Diagnostics (clinical validation at four processing laboratories)
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary for the Pathwork Tissue of Origin Test (K080896). Cleared 2008-07-30.

    Based on the n = 545 results, the probability that a true positive tissue call was obtained when a Similarity Score of ≥ 30 was reported was 92.9%, 95% CI [90.3, 95.0], and the probability that a true negative tissue call was obtained when a Similarity Score of ≤ 5 was reported was 99.7%, 95% CI [99.6, 99.8].

Details

AI system

Workflow

RNA from fresh-frozen tumor tissue was hybridized to the Pathchip microarray and scanned. Laboratories processed specimens as the Pathwork Specimen Processing Guide sets out.

Follow-up

Conditions for replication

The tumor can be diagnosed according to current clinical and pathological practice. A qualified clinician reads the result in the context of the patient's clinical history and other tests.

Entry details

Sector

Healthcare.

Purpose

Pathwork Diagnostics built the Tissue of Origin Test to measure how closely a tumor's RNA expression pattern resembles each of 15 common tumor types, for use with other diagnostic tests.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). Pathwork Tissue of Origin Test matched the known origin of most tumors (AIBD-0808). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0808.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

BibTeX Data Field definitions