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Approval of first tumor gene panel sends shockwaves through labs

Nature Biotechnology volume 36, pages 124–125 (2018)Cite this article

“[FDA]'s been thinking about laboratory-developed assays for many years,” says Marc Ladanyi, chief of the molecular diagnostics service at Memorial Sloan Kettering. The agency had told Congress in 2014 that it intended to regulate laboratory developed tests (LDTs) (Nat. Biotechnol. 32, 855, 2014), and at the same time the question of how to regulate large-panel, next-generation sequencing (NGS) assays was bubbling up as these tests became widespread. “The two issues converged in relation to our submission,” says Ladanyi. In early 2017, FDA let Memorial Sloan Kettering know they would welcome an application for MSK-IMPACT (integrated mutation profiling of actionable cancer targets) as a class II device using the de novo pathway, a route used mostly for low- to moderate-risk novel devices. “The interest from their part was to pilot this approval mechanism for LDTs,” he says.

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  1. Tequesta, Florida

    Mark Ratner

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Ratner, M. Approval of first tumor gene panel sends shockwaves through labs. Nat Biotechnol 36, 124–125 (2018). https://doi.org/10.1038/nbt0218-124

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