Omics Biomarkers in Precision Oncology: From the Lens of the ASCPT Biomarkers and Translational Tools and Oncology Communities

Sep 22, 2026

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Omics biomarkers include genomic, epigenomic, transcriptomic, proteomic, and metabolomic signatures that support oncology drug development and personalized clinical decision-making. In precision oncology, validation is typically harder than discovery, so discussed biomarkers range from those endorsed in clinical guidelines to still-investigational markers. The article reviews types such as epigenetic, transcriptomic, proteomic, and ctDNA signatures, and how they inform prognosis, detection, and therapy response. It also highlights opportunities and constraints in integrating evidence.

LanguageEnglish

CategoryResearch & Report

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Pages8

Reading Time20 min

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Abstract

Different Types of Omics Biomarkers Used in Oncology Settings

Role of Omics Biomarkers in Precision Oncology

Clinical and Translational Science Omics Biomarkers in Precision Oncology: From the Lens of the ASCPT Biomarkers and Translational Tools and Oncology Communities Mai Mehanna1 | Hardik Mody2 | Joy C. Hsu2 | Julia Quintanilha3 | Zachary L. Taylor4,5,6 | Angela James7 | Binita Rajbanshi8 | Pooja Manchandani9 | Lakshmi Manasa Chekka10 1Clinical Pharmacy Department, Faculty of Pharmacy, Misr International University, Cairo, Egypt | 2Clinical Pharmacology, Genentech, South San Francisco, California, USA | 3Clinical Development, Foundation Medicine, Inc. , Boston, Massachusetts, USA | 4Division of Translational and Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA | 5Cancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA | 6Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA | 7TEQ Enterprises, Evanston, Illinois, USA | 8Department of Neurology, University of California San Francisco, San Francisco, California, USA | 9Clinical Pharmacology Division, Nurix Therapeutics Inc, Brisbane, California, USA | 10Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA Correspondence: Mai Mehanna ([phmai1148@gmail.com](phmai1148@gmail.com)) Received: 21 March 2026 | Revised: 29 July 2026 | Accepted: 10 August 2026 Keywords: biomarkers | omics | oncology | precision medicine | ABSTRACT
Omics biomarkers comprise several molecular entities, including genomic, epigenomic, transcriptomic, proteomic, and metabolomic signatures. They play an essential role in oncology drug development and clinical settings by enabling personalized medicine. In precision oncology, validating biomarkers is a greater challenge than discovering them. The biomarkers discussed here span a wide evidentiary spectrum, from those endorsed in clinical guidelines to those that remain investigational. | | | --- | --- | | 1 | Different Types of Omics Biomarkers Used in | To fully navigate the complexity of cancer biology, integrating | | Oncology Settings | additional omics data is necessary. Epigenetic alterations, including DNA methylation, histone modification, and acetylation, as | | Biomarkers derived from somatic DNA alterations in tumor | well as miRNAs and lncRNAs, influence gene expression pat- | | cells, including point mutations, copy number alterations, and | terns, steering oncogenesis. By decoding epigenetic biomarkers, | | rearrangements, are linked to cancer prognosis and therapeu- | the field has gained insights into cancer prognosis and the op- | | tic outcomes across various cancer drugs, especially targeted | timal design of therapeutic agents [3] . Transcriptomic profiling | | therapies. Given the heterogeneous nature of cancer, polygenic | also reveals regulatory networks in cancer cells, thereby eluci- | | risk scores (PRS) have gained significant attention. However, | dating cancer detection and prognosis. Deep proteomic profiling | | only a few PRS are currently integrated into clinical practice [1] . | unveils the intricate protein networks and identifies targets for | | Additionally, complex genomic biomarkers assessing microsatellite instability and tumor mutational burden are widely used | novel therapeutic agents [2] . | | in clinical settings to predict response to immune checkpoint | Circulating tumor DNA (ctDNA), which is fragmented DNA | | inhibitors. Furthermore, emerging signatures related to homol- | released by tumor cells into the bloodstream, is used to assess | | ogous recombination deficiency are used to predict response to | tumor genetics and epigenetics. ctDNA offers superior sensi- | | DNA damage-targeting drugs [2] . | tivity/specificity compared to traditional plasma biomarkers, | | This is an open access article under the ter

FAQs

What are omics biomarkers, and why are they important in oncology?

Omics biomarkers are molecular signatures spanning genomic, epigenomic, transcriptomic, proteomic, and metabolomic levels. They support oncology drug development and clinical settings by enabling personalized medicine.

Why is validating precision-oncology biomarkers often harder than discovering them?

The document states that, in precision oncology, validating biomarkers poses a greater challenge than discovering them, reflecting differences in evidentiary strength and clinical readiness across biomarker types.

How is circulating tumor DNA (ctDNA) used in precision oncology?

ctDNA is fragmented DNA released by tumor cells into the bloodstream and is used to assess tumor genetics and epigenetics. The text notes that ctDNA can offer improved sensitivity/specificity compared with traditional plasma biomarkers for monitoring and decision support.

Sep 22, 2026

Upload by nayy☆