Back to press releases

Foundation Medicine Expands Indication for FoundationOne®CDx as a Companion Diagnostic for Piqray® (alpelisib)

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. FoundationOne CDx is the first and only FDA-approved broad comprehensive genomic profiling (CGP) test for all solid tumors, including breast cancer, that incorporates multiple companion diagnostics.

“Foundation Medicine is proud to achieve another FDA approval for FoundationOne CDx as a companion diagnostic for Piqray for the treatment of metastatic breast cancer with a PIK3CA mutation,” stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. “The advancements we are seeing in the treatment of breast cancer underscore the importance of harnessing genomic insights to enable personalized medicine. Taking a comprehensive and validated approach to genomic testing is critical for patients with metastatic breast cancer to help physicians determine a treatment roadmap upfront that may include FDA-approved targeted therapies like Piqray.”

In May of 2019, Novartis announced that the FDA approved Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen. PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation1. Professional guidelines were updated in September of 2019 to recommend assessment for PIK3CA mutations as part of the workup of HR+/HER2- advanced or metastatic breast cancer.

Piqray is the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer. Foundation Medicine and Novartis have an ongoing collaboration to support the development of companion diagnostics for the Novartis oncology portfolio.

Foundation Medicine will also be presenting new data at this year’s San Antonio Breast Cancer Symposium (SABCS) highlighting the utility of comprehensive genomic profiling in cancer care, including research on PIK3CA, as well as emerging biomarkers in breast cancer.

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 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. 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.

Piqray® is a registered trademark of Novartis AG.

1 The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70.

Lee-Ann Murphy, 617-245-3077

Source: Foundation Medicine

December 5, 2019