Biomarker Tests for Molecularly Targeted Therapies — The Key to Unlocking Precision Medicine Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Tuesday, June 07, 2016

Biomarker Tests for Molecularly Targeted Therapies — The Key to Unlocking Precision Medicine

NEJM (Perspective)

 June 1, 2016
As the promise and the pitfalls of precision medicine gain increasing attention,1,2 enthusiasm about the field has been heightened by a rapid reduction in the cost of high-throughput genomic sequencing and a dramatic increase in the identification of potential molecular targets for therapy. Biomarker tests for molecularly targeted therapies can help physicians to select the most effective therapy for a patient’s condition and avoid treatments that could be ineffective or harmful. If precision medicine is to reach its potential, such biomarker tests will have to be developed in a timely fashion.
Some observers, however, have expressed concern that these rapid developments have caused genomic data to accumulate at a rate that exceeds our ability to adequately capture, fully analyze, and properly interpret them. The medical armamentarium available to physicians seeking to tailor therapies to their patients’ conditions is expanding in parallel. Annual spending on molecularly targeted therapies for oncology in the United States now exceeds $10 billion, outpacing spending on conventional chemotherapies. In 2015 alone, the Food and Drug Administration approved 18 new agents for cancer, nearly all of which were based on the principles of precision medicine.
The degree to which physicians will be able to apply genomic information in selecting therapy that improves clinical care remains to be seen and will probably vary over the near term.3,4 The processes of identifying and validating biomarker tests and of developing and evaluating targeted therapies are complex. Potentially useful tests have not been adopted into clinical practice rapidly, in part because we lack common evidentiary standards for regulatory, clinical, coverage, and reimbursement decisions. Furthermore, clinical implementation will require the consistent collection and sharing of data on biomarker tests, treatments, and patient outcomes.5....


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