How a new genomic test could change cancer care –

How a new genomic test could change cancer care


CAMBRIDGE, Mbad. – (BUSINESS WIRE) – Foundation Medicine, Inc. (NASDAQ: FMI) today announced that the United States Food and Drug Administration (FDA) approved FoundationOne CDx ™, the company's comprehensive complementary diagnostic test for solid tumors. FoundationOne CDx is intended to be used by healthcare professionals to help inform the treatment of cancer treatment in accordance with professional guidelines for patients with solid tumors. The first and only approved test of this type for all solid tumors, FoundationOne CDx is a diagnostic test that acts as:

"Access to important genomic information is a critical step to be able to offer innovative and specific treatment options. "

Titee this

a complete complementary diagnosis to identify patients who may benefit from treatment with specific therapies approved by the FDA;

a comprehensive genomic profile test (CGP) that includes genomic biomarkers to help inform the use of other specific oncology therapies, including immunotherapies;

a tool for physicians that identifies the opportunities of patients for participation in clinical trials; and

a platform approved by the FDA for the development of complementary diagnostics for biopharmaceutical companies that develop precision therapies.

FoundationOne CDx evaluates all clbades of genomic alterations in 324 genes known to boost cancer growth, providing potentially actionable information to help guide treatment decisions. It is also indicated as a complementary diagnosis for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or bad cancer to identify those patients who may benefit from treatment with one of the 17 in the label directed therapies, which include 12 therapies currently approved as first line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutant loading (TMB), which can help inform the use of immunotherapies; genomic alterations in other genes relevant to the management of the patient; and relevant information about clinical trials.

According to previous CGP tests conducted by Foundation Medicine, it is estimated that approximately 1 in 3 patients in five common advanced cancers is expected to match an FDA-approved therapy.1 The number of matches is expected to be Label therapies indicated in FoundationOne CDx increase over time as Foundation Medicine and its biopharmaceutical partners seek approval from the FDA for additional complementary diagnostics on the platform. Today, approximately 50% of new cancer drugs in development have a complementary biomarker.2

Simultaneously with FDA approval, the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination ( NCD) preliminary for FoundationOne CDx. The draft NCD would provide coverage for the complementary diagnostic claims approved by the FDA, as well as a pathway for additional coverage with development of evidence in other types of solid tumors. The final policy is expected to be issued during the first quarter of 2018 following the public comments of the preliminary NCD and an administrative period.

"Today we know that many people with cancer do not receive biomarker tests, much less comprehensive genomic tests that must be combined efficiently with the best therapeutic option," said Andrea Ferris, president and CEO of LUNGevity Foundation. "This FDA approval means that, in a trial, patients can access therapies where complementary diagnoses have been established for their cancer while obtaining a broad tumor profile that can identify the therapies and clinical trials from which they could benefit most. Together with the preliminary determination of national coverage, this has the potential to democratize next-generation sequencing, reducing the barriers for patients treated in the community to access these biomarker-based treatments. "

" The genomic profile Complete is the gateway to precision medicine.This decision by the FDA and CMS, which can lead to Medicare patient coverage, represents an important step forward in improving the access of patients and physicians to precision medicine, both to establish a new quality standard for this type of test and to offer a coverage of potentially improved health. "Ankur R. Parikh, DO, Medical Director of Precision Medicine, Cancer Treatment Centers of America, said:" Access to important genomic information is a critical step in being able to offer innovative and specific treatment options. "

FoundationOne CDx are delivered in an integrated report that identifies alterations that match FDA approved therapies, identifies additional alterations in known genes boosting cancer growth, provides information on genomic biomarkers, including MSI and TMB, provides relevant information from clinical trials and includes interpretative content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

"The parallel historical review decision of today's FDA and CMS represent a breakthrough in personalized cancer care," said Troy Cox. , executive director of Foundation Medicine. "The doctors s will have an FDA approved test for all solid tumors in their toolkit that can inform targeted screening and immunotherapy, as well as identify patient opportunities for participation in clinical trials. Beyond its implications for patient care, we hope that FoundationOne CDx will provide biopharmaceutical companies with an FDA approved platform that can help accelerate drug development and enable personalized cancer care. On behalf of the Foundation Medicine team, I would like to thank FDA and CMS for their leadership and collaboration as we continue to work on the parallel review process with a shared mission to transform cancer care. "

FoundationOne CDx is the first test of the complete genomic profile of solid tumors reviewed by the FDA and the CMS in its Parallel Revision program The FDA approval was based on badytical validation and concordance studies with FDA approved trials.FoundationOne CDx is expected to be commercially available after the completion of the CMS NCD.

Telephone Conference and Webcast Details
Foundation Medicine will hold a conference call to discuss FDA approval and the draft of the CMS national coverage determination for FoundationOne CDx on Friday , December 1 at 8:30 a.m. ET To access the conference call by phone, I dial e 1-877-270-2148 from the United States and Canada, or dial 1-412-902-6510 internationally, and for any reference number of Foundation Medicine. Dial approximately ten minutes before the start of the call. You can access the live and live transmission of the conference call by visiting the investor section of the company's website at A reproduction of the webcast will be available shortly after the conclusion of the call and will be archived on the company's website for two weeks after the call.

About FoundationOne CDx ™
FoundationOne CDx ™ is a next-generation sequencing based on in vitro diagnostic device for the detection of substitutions, alterations in insertion and elimination (indels) and alterations in the number of copies ( CNA) in 324 genes and selected genetic rearrangements, as well as in genomic signatures that include microsatellite instability (MSI) and tumor mutational load (TMB) DNA isolated from formalin-fixed and paraffin-embedded tumor tissue samples (FFPE). The test is intended to be a complementary diagnosis to identify patients who may benefit from treatment with the targeted therapies listed below in accordance with the approved therapeutic labeling of the product. In addition, FoundationOne CDx is intended to provide tumor mutation profiles for use by qualified health professionals in accordance with professional guidelines in oncology for patients with malignant solid neoplasms. The FoundationOne CDx trial is a single-site trial conducted at Foundation Medicine, Inc.

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