USPTO Patent Application: Predicting Disease State by Analyzing cfDNA Fragments

ChangeBridge: Patent Apps - Pharma (A61K)

Published August 28th, 2025

Detected March 23rd, 2026

Summary

The USPTO has published a patent application (US20260080975A1) filed by Foundation Medicine, Inc. The application describes methods for predicting disease states by analyzing cell-free DNA (cfDNA) fragments. This is a routine publication of a patent application.

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What changed

This document is a publication of a United States Patent Application (US20260080975A1) filed by Foundation Medicine, Inc. The application details methods and systems for predicting a disease state by analyzing cell-free DNA (cfDNA) fragments. The described methods involve determining counts of methylated loci in cfDNA fragments within a specific size range, calculating a disease score by comparing this count to reference samples, and predicting the disease state based on a predetermined threshold.

As this is a patent application publication, it does not impose new regulatory obligations or compliance deadlines on regulated entities. It represents a disclosure of novel technology in the field of diagnostics and personalized medicine. Compliance officers should note this development for potential future impact on diagnostic test development and regulatory pathways for such technologies.

Source document (simplified)

← USPTO Patent Applications

METHODS AND SYSTEMS FOR PREDICTING A DISEASE STATE BASED ON ANALYZING CFDNA FRAGMENTS

Application US20260080975A1 Kind: A1 Mar 19, 2026

Assignee

Foundation Medicine, Inc.

Inventors

Mark R. KENNEDY, Justin NEWBERG

Abstract

Methods for predicting a disease based on analyzing cfDNA fragments are described. The methods may comprise, for example, determining, by one or more processors, a test count of methylated loci for cfDNA fragments within a size range for a test sample obtained from a subject; determining, by the one or more processors, a disease score based on comparing the test count of the methylated loci to a reference count of methylated loci from one or more reference samples; and predicting, by the one or more processors, the disease state for the subject based on a comparison of the disease score to a predetermined disease score threshold.