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Thermo Fisher Makes Final Push For ‘Universal’ Lung-Cancer Companion Dx

Executive Summary

The Oncomine Universal Dx looks in parallel for mutations on four genes associated with non-small cell lung cancer to help physicians pick between different drug options. Thermo Fisher has submitted its final PMA module to FDA.

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Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

Loxo Sees Larotrectinib As Model Form Of Oncology Drug Development

The pivotal data presented at ASCO showed a 76% response rate for the TRK inhibitor in patients with TRK fusion abnormalities, but there's still a lot left to prove about the tissue-agnostic model of drug development.

Multi-Companion Profiling Assay Enters FDA, CMS Express Lanes

The FoundationOne assay has been accepted into FDA's Expedited Access Pathway and the FDA/CMS Parallel Review program in an effort to advance what would be the first assay approved as a companion diagnostic for a range of tumor targets and drugs at once.


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