“With NGS there's an unprecedented ability to do multi-analyte analysis, and the cancer community has begun applying it to analyze tumors,” says Naomi O'Grady, senior manager, product marketing for oncology at Illumina. “Moving [a universal test] forward as a companion diagnostic emerged quite naturally,” and will make it easier for pharmaceutical companies to bring targeted therapies to market, she says. The advantage of a universal companion diagnostic is straightforward. As opposed to the one-biomarker, one-test approach—the way companion diagnostics have been developed thus far—a universal test allows researchers or clinicians to look at many different genes and mutations in a single sample. This reduces the amount of often painful- or difficult-to-obtain biopsy tissue needed, and provides much more actionable information to oncologists more quickly. “It's become obvious that a one-test, multiple-drugs solution is required and that next-generation sequencing is best suited to carry out that one test,” says Dan Rhodes, head of oncology for life sciences solutions at Thermo Fisher Scientific.
Take, for example, the specific indication of non-small cell lung cancer (NSCLC), for which two approved companion tests for epidermal growth factor receptor and anaplastic lymphoma kinase mutations may soon be joined by tests for BRAF oncogene and proto-oncogene tyrosine protein kinase ROS1 mutants. There is a host of drugs, in development or approved, that target those molecular subtypes. “If you only have a small tumor sample, as is often the case in NSCLC,” says Anne-Marie Martin, head of precision medicine and diagnostics and molecular medicine for the oncology therapy area at London-based GlaxoSmithKline, it creates a challenging situation for patients and physicians as there may not be sufficient tissue to run all available tests. Given industry's focus on targeted oncology therapies across multiple indications, “the problem will become staggering across many cancer types over the coming years,” says Rhodes.
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