Press Release: Food and Drug Administration (FDA) Approves FoundationOne Liquid Biopsy

NEWS RELEASE:

FDA Approves Foundation Medicine's FoundationOne®Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test with Multiple Companion Diagnostic Indications for Patients with Advanced Cancer

FDA Approval Includes Companion Diagnostic Claims for Rubraca® (rucaparib), the First PARP Inhibitor Approved in a Prostate Cancer Setting, and Three Tyrosine Kinase Inhibitors for Non-Small Cell Lung Cancer FoundationOne

Liquid CDx Analyzes More Than 300 Genes and Genomic Signatures to Help Inform Treatment Decisions for all Solid Tumor Cancers

CAMBRIDGE, Mass. – Wednesday, August 26 – Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®Liquid CDx, the Company’s comprehensive pan-tumor liquid biopsy test. FoundationOne Liquid CDx will be commercially available on Friday, August 28 and is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in accordance with the Centers for Medicare and Medicaid Services National Coverage Decision Memo criteria.

FoundationOne Liquid CDx is part of Foundation Medicine’s proven portfolio of FDA-approved tests and acts as:

• a companion diagnostic to identify patients who may benefit from treatment with specific FDA- approved targeted therapies, including an indication for Rubraca (rucaparib), a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration- resistant prostate cancer, and three first-line tyrosine kinase inhibitors (TKIs) for the treatment of non- small cell lung cancer;

• an FDA-approved test to enable accelerated companion diagnostic development for biopharma companies developing precision therapeutics; and

• a comprehensive genomic profiling test that reports genomic alteration results, including genomic signatures such as blood tumor mutational burden and high microsatellite instability, as well as single gene alterations, including all NTRK fusions, for patients with any solid tumor as an aid in patient care.

“We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” said Brian Alexander, M.D., M.P.H., Chief Medical Officer at Foundation Medicine. “Created from our scientific expertise and pioneering spirit, FoundationOne Liquid CDx underscores our commitment to advance patient care across all cancer types by bringing forward multiple FDA- approved comprehensive genomic profiling options that are increasingly essential for high-quality cancer care. We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance utility of the test in clinical practice. Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.”

Foundation Medicine’s proven portfolio of FDA-approved comprehensive genomic profiling tests includes FoundationOne®CDx, which helped pave the way for regulatory approvals of this kind as the first broad companion diagnostic approved by the FDA with Medicare coverage for qualifying patients across all solid tumors. The portfolio offers physicians important options for detecting specific genomic alterations that help guide efficient, personalized treatment decisions, while reducing the time and sample needed when testing for multiple biomarkers one at a time.

"From a clinical perspective, I believe physicians should discuss tumor genomic profiling with every metastatic prostate cancer patient to inform the use of targeted and immunotherapies," said Neeraj Agarwal, M.D., Director of the Genitourinary Oncology Program and Professor of Medicine at the Huntsman Cancer Institute, Salt Lake City, Utah. "This approval addresses the need for blood-based genomic testing options when tissue can be challenging to obtain."

Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for alterations. FoundationOne Liquid CDx results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies and, within its professional services section, delivers information about the genomic signatures microsatellite instability and blood tumor mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies. The report also provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

FoundationOne Liquid CDx is indicated for use as a companion diagnostic for four FDA-approved precision therapies, including an indication for Rubraca (rucaparib), a PARP inhibitor approved by the FDA for treatment of metastatic castration-resistant prostate cancer patients with BRCA1/2 mutations, and three first-line EGFR-TKIs for the treatment of non-small cell lung cancer patients.

“All patients should have access to high-quality genomic insights about what is driving their tumor to help inform personalized treatment planning,” said Andrea Ferris, President and Chief Executive Officer of LUNGevity Foundation. “For many patients, getting a tissue biopsy is not an option due to tumor location or the patient’s health status, or a patient may simply prefer not to have an additional procedure. Blood-based biomarker testing options can help to expand access to these actionable genomic insights in patients with advanced cancer.”

The FDA’s approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity (95% limit of detection (median) of 0.40% variant allele fraction (VAF) for select substitutions and indels, 0.37% VAF for select rearrangements, 21.7% tumor fraction (TF) for copy number amplifications, and 30.4% TF for copy number losses. Internal data on file.) and specificity (0% false positive rate for rearrangements and copy number alterations, 0.013% false positive rate for substitutions and indels. Internal data on file.), even at the low allele frequencies often observed in clinical blood samples.

“Liquid biopsies are becoming an increasingly important option to inform personalized treatment decisions for physicians treating certain advanced cancer patients who require minimally invasive solutions to genomic testing,” said Mark Socinski, M.D., Executive Director (Thoracic Cancer) and Medical Oncologist at the AdventHealth Cancer Institute, Orlando, Florida. “This approval helps expand access to important genomic information needed for physicians to make more informed decisions about targeted treatment approaches for their patients and is another important step toward making comprehensive genomic testing a part of routine clinical cancer care.”

FoundationOne Liquid CDx is available to order on Friday, August 28 at foundationmedicine.com/order, or visit foundationmedicine.com/signup to register for an account.