Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Partnerships Are Key To Foundation Medicine's Success

Executive Summary

Since receiving approval for the first broad-panel diagnostic test as a combination product to detect cancer, Foundation Medicine has ramped up its partnerships with pharmaceutical companies and other stakeholders. The company expects to receive a similar approval for a broad-panel liquid biopsy genomic test in the first half of 2020.

You may also be interested in...

December 2019 Approvals Snapshot: Abbott Earns New Approval For CentriMag Circulatory Support System

December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.

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.

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.


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts