Skip to main content
Premium Trial:

Request an Annual Quote

Biomarkers Government Agencies Launch Initiative for Cancer Therapies


To develop therapeutics for oncology patients, wouldn’t it be better to incorporate biomarker research from the get-go? This is one of the thoughts behind the Oncology Biomarker Qualification Initiative, a collaboration between the Food and Drug Administration, National Cancer Institute, and the Centers for Medicare and Medicaid Services. These agencies will work with public and private institutions to understand how biomarkers, including genomic and proteomic markers, can be used to assess the impact of therapies and better match therapies to patients.

“When Herceptin was being developed, the company didn’t necessarily start off thinking how to identify patients who would actually respond to the drug,” says Wendy Sanhai, a senior scientific advisor at the FDA. It was at the insistence of the FDA, she says, that the company added the HER2 IHC diagnostic. Having a biomarker for a cancer therapeutic should be the rule rather than the exception, says Sanhai.

Through the recently announced initiative, collaborators will work together to address questions such as how particular biomarkers can be used to identify which cancer patients are at high risk of tumor recurrence; how to determine if a patient’s tumor is likely to respond to a specific treatment; and how to efficiently evaluate whether an investigational therapy is effective for tumor treatment. In the future, researchers envision being able to use biomarkers to assess, after one or two treatments, if a patient’s tumor is responding to treatment, or determine more definitively if a tumor is dying even if it’s not shrinking.

Validating biomarkers can help shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between the drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.

“Many potential biomarkers in the form of genes and proteins are beginning to provide clues about the presence of cancer or a precancer. Others, or even the same markers, are also informing us about the prognosis — the future course of an individual cancer,” says Dean Brenner, a biomarker researcher at the University of Michigan. “Such products are coming toward [the] market. We need a way to define what works and what does not work. [This] initiative recognizes the importance of development and validation of intermediate endpoints that might be used to predict more distant clinical endpoints.”

— Kate O’Rourke

The Scan

Genetic Risk Factors for Hypertension Can Help Identify Those at Risk for Cardiovascular Disease

Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.

Circulating Tumor DNA Linked to Post-Treatment Relapse in Breast Cancer

Post-treatment detection of circulating tumor DNA may identify breast cancer patients who are more likely to relapse, a new JCO Precision Oncology study finds.

Genetics Influence Level of Depression Tied to Trauma Exposure, Study Finds

Researchers examine the interplay of trauma, genetics, and major depressive disorder in JAMA Psychiatry.

UCLA Team Reports Cost-Effective Liquid Biopsy Approach for Cancer Detection

The researchers report in Nature Communications that their liquid biopsy approach has high specificity in detecting all- and early-stage cancers.