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FoundationOne®CDx Receives FDA Approval as a Companion Diagnostic for BRAF Inhibitor Therapeutics in Melanoma

Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as a companion diagnostic across a group of targeted therapies.

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations. This approval makes FoundationOne®CDx the only comprehensive genomic profiling (CGP) test approved as a companion diagnostic across two groups of targeted therapies, representing an important step toward simplifying decision making for oncologists.

Melanoma is a serious form of skin cancer that accounts for an estimated 207,790 cases each year.1 BRAF mutations are the most common type of mutation in melanoma and are present in more than half of all melanoma cases.2 As a companion diagnostic for therapies targeting BRAFV600E and BRAFV600K mutations in melanoma, FoundationOne®CDx offers oncologists flexibility when selecting the right therapy for their melanoma patients and ensures all treatment options are considered within these groups of therapies.

“As the first group therapy approval for any comprehensive genomic profiling test, this milestone reinforces our dedication to pioneering advances that expand the power of genomic testing in cancer care,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “This approval will allow oncologists to uncover all possible FDA-approved treatment options for these indications through just one test, providing more insights for physicians and patients, more efficiently than ever before.”

This approval represents an innovative, more efficient regulatory approach that simplifies the companion diagnostic approval process for biopharma companies developing BRAF inhibitor therapeutics, while maintaining rigor and high-quality standards.

The first new therapeutics for which FoundationOne®CDx is a companion diagnostic under the group approvals are Pfizer’s BRAFTOVI®/MEKTOVI®and Novartis Tafinlar® (dabrafenib) + Mekinist® (trametinib) combination therapeutics. Moving forward FoundationOne®CDx will automatically become a companion diagnostic for future BRAF inhibitors that are approved by the FDA under these groups.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine® and FoundationOne ® are registered trademarks of Foundation Medicine, Inc.

BRAFTOVI ® and MEKTOVI ® are registered trademarks of Pfizer.

TAFLINAR® and MEKINIST® are registered trademarks of Novartis.

Source: Foundation Medicine


Foundation Medicine:
Erin Smith, 262-914-2779

Source: Foundation Medicine

December 9, 2021