Drugs

Steps Needed for Better Biomarker Use: Researchers

Two researchers who were on the Institute of Medicine’s Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies say there are steps that should be taken to improve the usefulness of biomarkers as part of precision medicine. Writing in a New England Journal of Medicine Perspective, the two call for a national initiative involving not only clinicians and laboratory scientists but also experts in informatics to continuously capture, catalog, and annotate data on biomarkers and targeted therapies and make them available to regulators, providers, payers, and patients who want to take a more active role in shared decision-making.

They reference their committee’s 10 specific and wide-ranging recommendations based on the premise that properly validated and implemented biomarker tests and targeted therapies “hold considerable promise for enhancing the quality of patient care and improving meaningful clinical outcomes.” First and foremost, they say, the committee called for development of common standards for assessing the utility of biomarker tests in the selection of targeted therapies and improvement of patient outcomes. “Such standards,” they say, “would inform regulatory oversight of test development and approval, appropriate clinical adoption and utilization, and decisions about coverage and reimbursement. Interoperability and integration of electronic health records and laboratory information systems, ideally by means of a national database for healthcare providers and patients, would enhance the sustainable implementation and continuous evaluation of such tests.”

The committee further recommended that equitable access to biomarker tests and targeted therapies be ensured through patient and provider education, simplified and informative labeling, and supportive reimbursement policies.

“The committee’s recommendations are meant to guide both the development of evidence supporting initial clinical application of biomarker tests and the ongoing assessment of their benefit,” the article says. “Given that the apparent value or benefit of biomarkers for a molecularly targeted therapy may vary considerably, a primary goal of the committee’s recommendations is to increase patients’ access to appropriate, accurate, reliable tests that can direct personalized or precision therapy.”

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome