Biomarker Tests Hindered by Lack of Sufficient Evidence and Regulation

Precision medicine aims to deliver the most appropriate treatment to individual patients; however, biomarker tests that are poorly validated or inappropriately applied could hinder administration of appropriate treatments, and in some cases motivate the use of harmful treatment, according to a recent report by the National Academy of Sciences.1

Biomarker tests examine molecular signals specific to a patient to determine effective therapy or therapy that could be futile or harmful. Hundreds of biomarker tests have entered the drug development path, with many being used with associated therapies in the clinical setting for the treatment of cancer.

This study cited a lack of common evidentiary standards for biomarker test approval, inefficient and inconsistent reimbursement and regulatory protocols, a need for effective data collection about patients' tests, treatments, and outcomes, and a need to use new knowledge to improve patient care and prognosis.

The committee generated 10 goals, describing recommended approaches for achieving the goals. This report suggested that successful achievement of all 10 goals could address issues of proper experimental validation and appropriate clinical use of biomarker tests to improve patient care and prognoses.

"The timely development of biomarker tests and associated therapies is critical to realizing the full potential of precision medicine," said Harold Moses Jr, MD, chair of the committee that wrote the report, and Ingram Professor of Cancer Research, professor of medicine, pathology, microbiology, and immunology, and chair of the department of cancer biology at Vanderbilt University, Nashville, Tennessee.

"Our report lays out a strategy to ensure that patients have access to effective tests and treatments that are based on solid evidence of their ability to improve health outcomes."

The committee noted that precision medicine could increase disparities in access to advanced health care services such as biomarker tests. The report suggested that better patient and clinician education and improved collaboration across health care settings could ameliorate some disparities.


1. National Academies of Sciences, Engineering, and Medicine. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington DC: The National Academies Press; 2016. doi:10.17226/21860.

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