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Foundation Medicine Seeks "Go-To" Companion Diagnostic Status For Sequencing Test

This article was originally published in The Gray Sheet

Executive Summary

The firm is barely more than a year old, but Cambridge, Mass.-based Foundation Medicine has set its sights on offering a one-stop companion diagnostic for cancer treatments using next-generation genome sequencing.

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First Expedited NGS Test Breaks Through FDA Review

FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.

Roche Gains Majority Stake In Foundation Medicine With R&D, Commercial Partnership

Roche is investing up to $1.18 billion in the genomic analysis firm, inking a partnership focused on companion diagnostics, cancer drug development and expanded marketing of Foundation's novel sequencing-based platform.

Start-Up Quarterly Statistics, Q4 2011

Biopharma start-ups raised $693 million in Q4 2011, up 131% from Q3. Device companies brought in $111 million, and diagnostics firms raised $120 million total, $96 million of which was from Biocartis’ Series C. Cancer was the most prevalent therapeutic area for biopharma alliances. And in great contrast to Q3’s one M&A deal involving a start-up company, Q4 saw nine start-up acquisitions.

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