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Vera Grossmann, Vice President of International Operations and Managing Director, Foundation Medicine, GmbH, based in Germany; Robert Loberg, Vice President and Lifecycle leader for the Oncology & Genetics team at Roche Diagnostics, Roche and Foundation MedicineFoundation Medicine, Inc., a wholly owned subsidiary of Roche, mitigates this challenge with its suite of comprehensive genomic profiling (CGP) assays that can identify molecular alterations in a patient’s cancer in one comprehensive panel and match them with an overview of best-suited targeted therapies, immunotherapies or clinical trials via a detailed results report. By determining options of a treatment path tailored to the unique genomic profile of a person’s tumor, the technology can help patients avoid unnecessary treatments and unpleasant side effects, subsequently supporting healthcare systems to be more sustainable in the long term. The company’s CGP tests can evaluate blood and tissue samples with a single biopsy to assess more than 300 genes known to be associated with cancer behavior and growth.
“Our high-quality CGP assays provide physicians with insights into the unique biology of each patient to support clinical decision-making, and drive faster development of new life-saving cancer treatments,” says Vera Grossmann, Vice President of International Operations and Managing Director, Foundation Medicine, GmbH, based in Germany. In addition, with emerging blood-based CGP tests, physicians will be able to monitor the progress of a patient’s cancer over time using blood samples to identify any possible signs of treatment resistance. They can then develop a new treatment plan accordingly, and patients may avoid multiple tissue biopsy procedures as the cancer progresses.
Foundation Medicine’s mission is to transform cancer care by consolidating all the information needed to make a data-driven clinical decision. In 2018, the company was acquired by the Roche Group, combining Foundation Medicine’s world renowned next-generation sequencing (NGS) offerings with Roche’s cancer R&D expertise.
Together, Foundation Medicine and Roche have developed a research use-only offering, called the AVENIO Tumor Tissue CGP kit, which provides an end-to-end workflow from DNA extraction and library preparation to generation of variant results by the FoundationOne® Analysis Platform.
The Kit uses a gene panel designed to match the FoundationOne® CDx panel across four main classes of genomic alterations and genomic signatures known to cause and drive cancer.
In a world where the state-of-the-art evaluation of cancer patients is predominantly focused within large healthcare systems and research facilities, Roche and Foundation Medicine’s combination of expertise allows them to offer a portfolio of solutions, including decentralized testing options. By doing this, Foundation Medicine aims to support physicians and researchers to gain a deeper understanding of the disease and ultimately reshape the healthcare system, redefine the way each patient with cancer is treated, make cancer a more manageable disease (particularly in the advanced setting), and enable many more patients with cancer to lead a long, fulfilling life that is not dominated and defined by their disease.
The AVENIO Tumor Tissue CGP Kit is designed to allow labs to conduct oncology research with CGP in-house, expanding personalized cancer research and supporting researchers in navigating the complex landscape of cancer. All of these assays are backed by the company’s unique knowledge base, FoundationCore® one of the largest databases of real-world anonymous CGP results in oncology, which evaluates the genomic landscape across cancer types to better understand tumor biology, molecular biomarkers, and appropriate treatments, enabling researchers and biopharma companies to develop new therapies and design better clinical trials, and advance precision medicine.
Combining genomic data with patient clinical history data—for example past and current illnesses and the efficacy of treatments over time—can provide additional pieces to the complex puzzle. In partnership with Flatiron Health, Roche and Foundation Medicine have completed an ambitious project to combine a subset of their data into the first-of-its-kind clinico-genomic database. The FMI-Flatiron Health database recently reached more than 100,000 patients and has enabled the company and its partners to publish more than 100 publications focused on precision oncology.
“Our mission going forward is to transform cancer care by blending our diagnostics prowess with Foundation Medicine’s decade-long CGP expertise, enriched with powerful genomic data insights, to make impactful and timely clinical decisions possible for physicians and diagnosticians worldwide, in turn improving outcomes for patients,” states Robert Loberg, Vice President and Lifecycle leader for the Oncology & Genetics team at Roche Diagnostics.
Our high-quality CGP assays provide physicians with insights into the unique biology of each patient to support clinical decision-making, and drive faster development of new life-saving cancer treatments
In a world where the state-of-the-art evaluation of cancer patients is predominantly focused within large healthcare systems and research facilities, Roche and Foundation Medicine’s combination of expertise allows them to offer a portfolio of solutions, including decentralized testing options. By doing this, Foundation Medicine aims to support physicians and researchers to gain a deeper understanding of the disease and ultimately reshape the healthcare system, redefine the way each patient with cancer is treated, make cancer a more manageable disease (particularly in the advanced setting), and enable many more patients with cancer to lead a long, fulfilling life that is not dominated and defined by their disease.
On a mission to transform cancer care
Vera Grossmann, Vice President of International Operations and Managing Director, Foundation Medicine, GmbH, based in Germany
Our three comprehensive genomic profiling tests have been designed to give physicians and patients powerful actionable insights to help navigate the complex space of cancer care
Company
Roche and Foundation Medicine
Management
Vera Grossmann, Vice President of International Operations and Managing Director, Foundation Medicine, GmbH, based in Germany; Robert Loberg, Vice President and Lifecycle leader for the Oncology & Genetics team at Roche Diagnostics, Roche and Foundation Medicine
Description
A molecular information company dedicated to a transformation in cancer care in which a deep understanding informs treatment of the genomic changes that contribute to each patient’s unique cancer
Roche and Foundation Medicine News
U.S. Food and Drug Administration (FDA) Approves FoundationOne®CDx as a Companion Diagnostic for Lilly’s Retevmo® (selpercatinib) for Certain Patients with Solid Tumors
CAMBRIDGE - 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 Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
This announcement signifies Foundation Medicine's fifth pan-tumor approval in the United States for FoundationOne CDx, which is the sole tissue test holding multiple biomarkers approved as a tumor-agnostic companion diagnostic in the U.S. These biomarkers include TMB and NTRK1/2/3. This achievement also marks Foundation Medicine's ninth approved companion diagnostic indication, encompassing seven distinct fusion genes (ALK, ROS1, NTRK1, NTRK2, NTRK3, FGFR2, and now RET).
FoundationOne CDx, utilizing a tissue sample, examines over 300 genes related to cancer to identify genomic alterations within a patient's tumor. This comprehensive analysis facilitates a personalized treatment approach and helps determine whether Retevmo is a suitable treatment option for patients with RET gene fusions, a condition found in less than two percent of solid tumors. Currently, the test boasts over 30 companion diagnostic indications, covering various types of malignancies, including lung, breast, prostate, colon, and other solid tumors.
“With a growing need for solutions for patients with rare fusions, high-quality companion diagnostics provide critical information to support oncologists in the development of personalized treatment plans,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “With our experience successfully navigating the complexities of a pan-tumor approval, we’re proud to have another companion diagnostic for our FDA-approved tissue test that can help enable broader access to an important therapy option for RET-fusion positive solid tumors. We appreciate this meaningful collaboration with Lilly to help bring more treatment options to patients facing a cancer diagnosis.”
“One of our top priorities is helping people living with lung cancer access the best treatment possible and this approval marks a milestone on the path to developing highly personalized care for them,” said GO2 for Lung Cancer President & CEO Laurie Ambrose. “We are encouraged by the expanded access and options they will receive and are confident this will positively impact the lives of people living with cancer and their loved ones.”
Foundation Medicine holds a prominent position as a worldwide leader in companion diagnostic approvals. Notably, the company has garnered the majority, specifically 60%, of all companion diagnostic approvals for next-generation sequencing (NGS) testing in the United States. This most recent companion diagnostic approval represents the culmination of an ongoing series of collaborative endeavors between Foundation Medicine and Lilly.
Please note that "Foundation Medicine®" and "FoundationOne®" are registered trademarks of Foundation Medicine, Inc., while "Retevmo®" is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.