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April Edition 2022

Foundation Medicine – Pioneering the Future of Cancer Care by Accelerating the Development of Novel Therapies

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Cancer is a result of an uncontrolled growth of abnormal cells, driven by genetic (molecular) changes that are either acquired or inherited from our parents. Each cancer has a unique set of molecular changes in the cancer cells. Technological developments have made a molecular profiling analysis possible; this allows doctors to distinguish the molecular differences between cancer cells and healthy cells. Molecular test findings provide doctors with the information they need to review what genes have been changed (mutated). By identifying these mutations, your doctor can figure out if one treatment may work better than another for you.

Foundation Medicine is one such company founded in 2010 with a mission to bring deep molecular information to the point of care for every patient living with advanced cancer. It 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.

Cutting-Edge Testing Techniques Offered by Foundation Medicine

FoundationOne CDx: FoundationOne®CDx is a qualitative next-generation sequencing-based in vitro diagnostic test for advanced cancer patients with solid tumors and is only for prescription use. The test analyzes 324 genes and genomic signatures, including microsatellite instability (MSI) and tumor mutational burden (TMB). It is a companion diagnostic to identify patients who may benefit from treatment with specific therapies following the approved therapeutic product labeling. Additional genomic findings may be reported and not prescriptive or conclusive for the use of any specific medicinal product.

FoundationOne Liquid CDx: FoundationOne Liquid CDx is an FDA-approved companion diagnostic that analyzes guideline-recommended genes from a simple blood draw. It is the only FDA-approved blood-based test to explore over 300 genes—making it the most comprehensive FDA-approved liquid biopsy on the market. This test also reports blood tumor mutational burden (bTMB), microsatellite instability (MSI),†, and tumor fraction values as a professional service. With more targeted therapy options, comprehensive genomic profiling with FoundationOne Liquid CDx can help guide treatment strategies and help predict patient benefit across multiple cancer indications.

FoundationOne Heme: FoundationOne Heme is a comprehensive genomic profiling (CGP) test combining DNA and RNA sequencing for patients with hematologic malignancies, sarcomas, or solid tumors where RNA sequencing is desired. FoundationOne Heme detects known, novel, and complex fusion events and other common genomic alterations (substitutions, indels, and CNVs). This laboratory-developed test (LDT) can be used by physicians to identify potential targeted therapy options, detect alterations in prognostic genes, and sub-classify sarcoma diagnoses.

PD-L1 IHC Testing at Foundation Medicine: The results of PD-L1 IHC testing combined with CGP results, including data on tumor mutational burden (TMB) and microsatellite instability (MSI), may help you make more informed treatment decisions regarding the use of immunotherapies and enrollment in appropriate clinical trials for your patients. PD-L1 Dako 22C3 pharmDx is a qualitative immunohistochemical assay using monoclonal mouse anti-PD-L1 clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissue from multiple tumor types by the approved product labeling.  For tumors with no CDx indication, Foundation Medicine will perform PD-L1 testing using the Dako PD-L1 22C3 PharmDx assay.

FoundationCore®: With over 400,000 patient profiles, FoundationCore is one of the largest databases of real-world comprehensive genomic profiling results in oncology. It's also constantly evolving, typically adding more than 2,000 samples per week and has updated analyses and new biomarkers added to existing samples.  In addition to deep information on genomic alterations, computational biomarkers such as tumor mutational burden (TMB) and microsatellite instability (MSI) status are available, as are PD-L1 results.  FoundationCore is a pan-tumor and pan-center, providing a breadth of quality results from validated tests (including the FDA-approved FoundationOne®CDx).

“Foundation Medicine is transforming cancer care by providing patients, physicians and researchers with a deep understanding of the genomic mutations that drive cancer.”

The Visionary Leader Upfront

Brian Alexander, MD, MPH is the Chief Executive Officer of Foundation Medicine. He previously served as the company’s Chief Medical Officer since 2019, and is a practicing radiation oncologist specializing in neuro-oncology at Dana-Farber/Brigham and Women’s Cancer Center, and a Senior Lecturer at Harvard Medical School.

Since joining the company in September 2018 as a Senior Vice President of Clinical Development, Dr. Alexander has played a pivotal leadership role in Foundation Medicine’s decision insights strategy, helping oncologists, both in community and academic settings, determine the right treatment, at the right time, for each unique patient. Under his leadership, Foundation Medicine’s medical team has expanded its molecular tumor board program to include over 90 leading oncology centers globally, launched a cross-functional genomics and health disparities effort, and has developed hundreds of studies and publications to advance the clinical utility of genomic profiling.

Dr. Alexander received his B.A. from Kalamazoo College, M.D. from the University of Michigan Medical School, and M.P.H. from the Harvard School of Public Health. He completed his training in radiation oncology at the Harvard Radiation Oncology Program.

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