Foundation Medicine

Foundation Medicine
Name	Foundation Medicine, Inc.
Foundation	2010
Location	Cambridge, Massachusetts, United States
Key people	Cindy Perettie (CEO), Michael J. Pellini (former CEO), Troy Cox (Chairman)
Industry	Molecular diagnostics, Precision medicine
Products	FoundationOne CDx, FoundationOne Liquid CDx, FoundationOne Heme
Parent	Roche (since 2018)
Website	foundationmedicine.com

Foundation Medicine. It is a commercial-stage molecular information company dedicated to transforming cancer care through comprehensive genomic profiling. Founded in 2010 by a group including Eli Broad, Eric Lander, and Todd Golub, the company aims to bring the power of genomic sequencing to routine clinical practice. Its tests analyze a patient's tumor to identify the molecular alterations driving the cancer, enabling physicians to make more informed treatment decisions.

History

The company was launched in 2010 with foundational support from the Broad Institute and MIT's Eli and Edythe Broad Institute. Key scientific founders included Eric Lander, a principal leader of the Human Genome Project, and Todd Golub, a renowned cancer genomics researcher. Its initial leadership included Michael J. Pellini as CEO, who guided its early growth and initial public offering on the NASDAQ in 2013 under the ticker FMI. In 2015, it entered a significant collaboration with Roche, which deepened in 2018 when Roche completed a full acquisition, integrating it into its Roche Diagnostics division. Under Roche, leadership transitioned to Cindy Perettie, formerly of Roche Sequencing Solutions.

Products and services

Its flagship product is FoundationOne CDx, a companion diagnostic test that analyzes 324 genes for solid tumors and is approved by the U.S. Food and Drug Administration for multiple targeted therapies. For blood-based testing, it offers FoundationOne Liquid CDx, a liquid biopsy assay detecting circulating tumor DNA. For hematologic malignancies, FoundationOne Heme provides genomic profiling for both DNA and RNA. The company also provides genomic data services to support pharmaceutical companies in drug development and clinical trials, such as those conducted by AstraZeneca and Bristol Myers Squibb.

Technology and methodology

Its tests utilize next-generation sequencing technology to perform deep, high-quality sequencing of tumor tissue or blood samples. The bioinformatics pipeline, developed in collaboration with the Broad Institute, processes sequencing data to identify various genomic alterations, including single nucleotide variants, copy number alterations, and gene rearrangements. For tissue-based tests, it employs rigorous pathology review and DNA extraction protocols. The liquid biopsy platform uses specialized techniques to isolate and analyze circulating tumor DNA from a standard blood draw, enabling non-invasive monitoring.

Clinical applications and impact

The primary application is matching patients with targeted therapies, such as osimertinib for EGFR mutations or pembrolizumab for tumor mutational burden-high status, as identified by its tests. This supports the practice of precision oncology in major cancer centers like Memorial Sloan Kettering Cancer Center and the Dana-Farber Cancer Institute. Its tests also help identify patients eligible for clinical trials of novel agents. By providing a standardized genomic report, it aids oncologists in navigating complex treatment guidelines from organizations like the National Comprehensive Cancer Network.

Partnerships and collaborations

Beyond the pivotal alliance with Roche, it maintains extensive collaborations with the global pharmaceutical industry. It has partnered with Pfizer on companion diagnostics for drugs like lorlatinib, and with Merck & Co. on integrating FoundationOne CDx with Keytruda. It works with academic institutions, including the American Association for Cancer Research and the American Society of Clinical Oncology, on research initiatives. Its data is also used in projects like the The Cancer Genome Atlas to advance public genomic knowledge.

Regulatory and quality framework

Its tests are regulated as medical devices by the U.S. Food and Drug Administration, with FoundationOne CDx holding multiple premarket approvals. The company's laboratories in Cambridge, Massachusetts and Roche's facility in Pleasanton, California are certified under the Clinical Laboratory Improvement Amendments and accredited by the College of American Pathologists. It adheres to rigorous standards for analytical validation and clinical validation, with its methodologies published in journals like The New England Journal of Medicine and Nature Medicine.

Category:Biotechnology companies of the United States Category:Precision medicine Category:Roche subsidiaries