Medical Test Validity Will Be Debated In 2016: 5 Storylines To Watch

Opinion

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therapy for patients based on mutations in their tumor lead to improved outcomes? The answer is clearly “yes” in some cases, like when the mutation is HER2 in breast cancer or more recently for BRAF v600 in melanoma. The answer is “sometimes” when changing histologies. Giving vemurafenib, which targets BRAF V600, to patients with non-melanoma cancers did lead to responses, but only in a subset of patients. These studies are used by payers to make decisions about coverage for genomic screening panels. The only related randomized control trial that has been completed, the SHIVA trial in France, also found that targeted agents didn’t improve survival when used outside their approved indication. While disheartening, small trials such as this Phase I trial at the MD Anderson Cancer Center suggest that there can be improvement. We still have work ahead to demonstrate improved outcomes based on genomic screening and targeted therapy.

Proper treatment selection is necessary for scientifically driven drug development and that requires assays able to reliably distinguish between patients. An issue repeatedly heard from test providers is that when reimbursement is too low—or lacking entirely—it discourages investment. Payers want to see improved patient outcomes. As drug developers, we need to be an active part of these discussions if we want to meet the ultimate goal of delivering drugs with greater value for patients.

*Prior examples of multi-stakeholder efforts directed to oncology testing include:

—The American Society of Clinical Oncology and the College of American Pathologists (CAP) providing guidance for HER2 testing for trastuzumab, which now has 10 approved companion diagnostic assays.

—CAP, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology providing guidelines for testing for epidermal growth factor receptor and anaplastic lymphoma kinase for use of tyrosine kinase inhibitors in lung cancer.

[Editor’s note: To tap the wisdom of our distinguished group of Xconomists, we asked a few of them to answer this question heading into 2016: “What is the most pressing issue for the innovation community in 2016?” You can see more questions and answers here.]

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Laura E. Strong, Ph.D. has more than 15 years of operational, strategic, and clinical development experience in biotech and health technology. Most recently, Dr. Strong is the founder and CEO of Propagate Health, which builds problem-oriented innovation networks across healthcare, life sciences, and technology stakeholders. Follow @scientre

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