Foundation Medicine

Foundation Medicine, a subsidiary of pharma giant Roche, is a molecular testing company that is engaged in developing and manufacturing companion diagnostic assays that are built on the company’s FoundationOne platform, using RNA-based next-generation sequencing (NGS) technology. The platform generates a genomic profile to identify biomarkers and gene alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies, and clinical trial options. The company was the first to receive US Food and Drug Administration (FDA) approval for its genomic profiling test that incorporated multiple companion diagnostics. 

The company’s suite of FDA-approved companion diagnostics (CDx) consists of FoundationOne CDx (tissue specimen) with 30 matching therapies and FoundationOne Liquid CDx (blood test) with ten matching therapies which are NGS-based in vitro diagnostic tests for advanced cancer patients with solid tumors. It also offers a genomic profiling test, FoundationOne Heme, for patients with blood-based cancers. The tests detect four main classes of genomic alterations across a broader panel of genes unlike a single marker (confined to one gene) of hotspot testing (confined to region).

In June 2023 , the company launched FoundationOne Monitor, a tissue-naïve circulating tumor DNA (ctDNA) monitoring assay for research use in retrospective studies. The company was acquired by Roche in 2018 for a total consideration of USD 2.4 billion and operates as an independent company, allowing it to continue its collaboration with Roche and other biopharma partners.

Foundation Medicine has expanded its partnership with China-based multi-omics research and clinical service provider Sequanta Technologies in October 2023. This partnership intended to provide genomic profiling services to support clinical research and the development of oncology therapies in China. Under this partnership, Foundation Medicine was expected to transfer its genomic profiling test technologies to Sequanta, starting with FoundationOne Liquid CDx in November 2023 and FoundationOne CDx in March 2024.

In November 2023, the company received FDA approval for FoundationOne CDx, a diagnostic intended for use with AstraZeneca’s Truqap (capivasertib) and Faslodex (fulvestrant) to treat advanced breast cancer in adults.

Key customers and partnerships

Foundation medicine partners with healthcare providers, as the tests are for prescription use only. Additionally, it collaborates with biopharma companies to profile patients, discover novel biomarkers, and co-develop companion diagnostics via its platform. As of June 2023, the company had delivered over 1 million reports and had over 500 peer-reviewed publications. 

In June 2023 , the company entered a strategic collaboration with Merck KGaA, Germany, to develop companion diagnostics using FoundationOne CDx and FoundationOne Liquid CDx for selected cancer treatments in the US market.

In December 2023, the company and biopharmaceutical company AnHeart Therapeutics entered a strategic partnership to aid the development and regulatory approval of genomic profiling tests for a cancer drug. The terms and financial details of the agreement were not disclosed. The collaboration aimed to develop genomic profiling tests, FoundationOneCDx and FoundationOneLiquid CDx, to serve as companion diagnostics for AnHeart's cancer drug, taletrectinib, ROS1 inhibitor, targeting non-small cell lung cancer.