Methods for early identification of bone healing ability in injured patients
Inventors
Horan, Annamarie D. • Mehta, Samir • Baldwin, Donald A.
Assignees
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Publication Number
US-12655482-B2
Publication Date
2026-06-16
Expiration Date
Abstract
The present invention relates to the discovery that the expression levels of some RNA molecules, comprising messenger RNA (mRNA), non-coding RNA (ncRNA) and/or microRNA (miRNA), and protein can be used as a diagnostic signature to predict or monitor the bone healing ability in an acutely injured subject or in a chronic nonunion subject. In certain embodiments, the invention relates to methods and compositions useful for differentiating between a nonunion, slow healing, and/or normal healing of a fractured bone and treatment recommendations. The invention further includes a kit comprising biomarker probes for assessing the bone healing ability in an acutely injured subject or in a nonunion subject after receiving therapeutic treatment.
Core Innovation
The invention relates to biomarker-based identification and monitoring of bone healing ability after a fractured bone. It uses RNA molecules, including mRNA, non-coding RNA, and microRNA, optionally together with protein biomarkers, to distinguish nonunion and slow healing from normal healing.
The difference in level or the difference in change of level of at least one RNA biomarker in a subject’s sample is compared against a reference sample to indicate nonunion or slow healing. The comparison is performed at a timepoint by comparing the subject’s biomarker level to a baseline level of the reference sample, or longitudinally by comparing the change between two or more times in the subject’s samples to a baseline change in reference samples collected at different times.
The RNA biomarker identity is restricted to specific RNA sequences (SEQ ID NOs: 1-1684 and 1830-1838), and the disclosure includes assay modalities for biomarker detection and profiling across cohorts and time to support prognostic discrimination among acute injury, nonunion, and normal healing.
Claims Coverage
The independent claim set covers a method of promoting bone healing by providing a nonunion-mitigating intervention when an RNA biomarker level difference or a change-in-level difference indicates nonunion or slow healing. Four inventive features are identified.
Nonunion-mitigating intervention triggered by RNA biomarker difference vs reference
Providing a nonunion-mitigating intervention to the subject when a difference in the level, or a difference in change of the level, of at least one RNA biomarker in a subject's sample as compared to the level of the at least one RNA biomarker in a reference sample is indicative of a nonunion or slow healing of the fractured bone in the subject.
Baseline-level comparison for RNA biomarker indication of nonunion or slow healing
Determining the difference in level by comparing the level of the at least one RNA biomarker in the sample from the subject to a baseline level of the at least one RNA biomarker in the reference sample.
Longitudinal change comparison for RNA biomarker indication of nonunion or slow healing
Determining the difference in change of the level by comparing the change of the level of the at least one RNA biomarker between samples collected from the subject at two or more different times to a baseline change of the level of the at least one RNA biomarker in reference samples collected at different times.
Restricted RNA biomarker set defined by SEQ ID NOs
The at least one RNA biomarker is selected from the group consisting of SEQ ID NOs: 1-1684 and 1830-1838.
The claims are directed to promoting bone healing by administering a nonunion-mitigating intervention when an RNA biomarker difference, either level or longitudinal change, versus a reference or baseline indicates nonunion or slow healing, using RNA biomarkers restricted to SEQ ID NOs: 1-1684 and 1830-1838.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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