# 2026-16441: Government Offers DNA-Based Cancer Classifier for Companies to License

2026-16441, Government Owned Invention Available for License: DNA Methylation-Based Cancer Diagnostics for Accurate Tumor Classification, is a Federal Register notice from Health and Human Services Department, National Institutes of Health published 2026-08-12; PRIA reads it as touching household money (as of 2026-10-28).

- Canonical: https://policyrisk.com/federal-register/2026-16441
- As of: 2026-10-28
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16441
- Title: Government Owned Invention Available for License: DNA Methylation-Based Cancer Diagnostics for Accurate Tumor Classification
- Type: Notice
- Agencies: Health and Human Services Department; National Institutes of Health
- Citation: 91 FR 52063
- Published: 2026-08-12
- Effective: unknown
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-10-28

## In one line

Government Offers DNA-Based Cancer Classifier for Companies to License

## Summary

The government has created a cool new tool that uses DNA patterns to help doctors classify cancer tumors more accurately, especially in the brain, kidney, and blood. This tech cuts down on guesswork and makes diagnoses clearer, helping patients get the right treatment faster. It’s ready for licensing now, so companies can bring this game-changing cancer test to clinics and labs soon.

## Abstract

This technology encompasses a DNA methylation-based diagnostic platform designed to improve the accuracy and consistency of cancer classification, with demonstrated utility for tumors of the central nervous system, kidney, and hematopoietic system. By identifying disease-specific methylation signatures, the approach reduces interobserver variability and enhances diagnostic confidence. The central nervous system (CNS) classifier is built from a curated reference set of 16,567 methylation profiles and organizes tumors into 22 families and 133 clinically relevant diagnostic classes, including 21 newly developed methylation classes not represented in other existing tools. Across multiple independent validation cohorts (n = 5,875), the classifier demonstrated robust performance, and in a clinical-impact analysis of 1,204 NIH validation cases, methylation profiling materially influenced final diagnosis in 74.4% of cases by refining, increasing precision, or reclassifying. The CNS classifier was deployed as a user-facing software tool, MethylScape Analysis, which streamlines methylation-based classification workflows for CNS tumors, https://methylscape.ccr.cancer.gov/. The development of multiple specialized classifiers supports a more granular understanding of tumor biology and informed clinical decision-making.

## Effects PRIA read

- More Accurate Tumor Diagnoses for Patients: benefit, high. If you or a family member has a tumor of the central nervous system (brain), kidney, or blood, this DNA methylation classifier helped change or refine diagnoses in clinical testing. In an NIH analysis of 1,204 cases, methylation profiling confirmed the initial diagnosis in 25.6% of cases and drove…
- Commercial Licensing Opportunity for Diagnostic Labs: benefit, medium. Companies, reference labs, and clinical laboratories can seek a license or collaboration to develop methylation-based diagnostic tests and software using NIH technology (NIH Reference Number E-105-2023-0). The notice lists specific commercialization activities such as external validation, assay sta…
- Public Web Tool for Running the Classifier: benefit, low. The CNS classifier is available through a user-facing public web portal, MethylScape Analysis, at https://methylscape.ccr.cancer.gov/, which the notice says streamlines methylation-based classification workflows for broad accessibility. The portal is presented as a deployment route for the classifi…

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## Sources
- [2026-16441 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/12/2026-16441/government-owned-invention-available-for-license-dna-methylation-based-cancer-diagnostics-for)
- [2026-16441 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-12/pdf/2026-16441.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-16441 (as of 2026-10-28).