Case 1:20-cv-01580-LPS Document 1-12 Filed 11/23/20 Page 1 of 5 PageID #: 466
`Case 1:20-cv-01580-LPS Document 1-12 Filed 11/23/20 Page 1 of 5 PageID #: 466
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`EXHIBIT 12
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`EXHIBIT 12
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`Case 1:20-cv-01580-LPS Document 1-12 Filed 11/23/20 Page 2 of 5 PageID #: 467
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`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
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`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
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`August 26, 2020 07:17 PM Eastern Daylight Time
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`CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced that the U.S. Food and Drug
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`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:
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`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.
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`“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
`Case 1:20-cv-01580-LPS Document 1-12 Filed 11/23/20 Page 3 of 5 PageID #: 468
`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.”
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`Foundation Medicine’s proven portfolio of FDA-approved comprehensive genomic profiling tests includes FoundationOne CDx,
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`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.
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`"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."
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`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.
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`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.
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`“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.”
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`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 and specificity, even at the low allele frequencies
`1
`2
`often observed in clinical blood samples.
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`“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.”
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`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.
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`About FoundationOne Liquid CDx
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`FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that
`uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA
`(cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-
`approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is
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`a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of
`the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported
`Case 1:20-cv-01580-LPS Document 1-12 Filed 11/23/20 Page 4 of 5 PageID #: 469
`and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a
`patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are
`negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an
`FDA-approved tumor tissue test, if available. For the complete label, including companion diagnostic indications and complete
`risk information, please visit www.F1LCDxLabel.com.
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`FoundationOne Liquid CDx is indicated for use as a companion diagnostic for:
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`Tumor Type
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`Biomarker(s) Detected
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`Therapy
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`Non-small cell lung
`cancer (NSCLC)
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`EGFR Exon 19 deletions and
`EGFR Exon 21 L858R substitution
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`BRCA1, BRCA2 alterations
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`Metastatic castration-
`resistant prostate
`cancer (mCRPC)
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`About Foundation Medicine
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`IRESSA (gefitinib)
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`TAGRISSO (osimertinib)
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`TARCEVA (erlotinib)
`®
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`RUBRACA (rucaparib)
`®
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`Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is
`informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company 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. For more information, please visit www.FoundationMedicine.com or follow
`Foundation Medicine on Twitter (@FoundationATCG).
`
`Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.
`®
`®
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`Rubraca is a registered trademark of Clovis Oncology, Inc.
`®
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`Iressa and Tagrisso are registered trademarks of the AstraZeneca AB Corporation.
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`®
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`Tarceva is a registered trademark of OSI Pharmaceuticals, LLC.
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`Source: Foundation Medicine
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` 95% limit of detection (median) of 0.40% variant allele fraction (VAF) for select substitutions and indels, 0.37% VAF for select
`1
`rearrangements, 21.7% tumor fraction (TF) for copy number amplifications, and 30.4% TF for copy number losses. Internal data
`on file.
` 0% false positive rate for rearrangements and copy number alterations, 0.013% false positive rate for substitutions and indels.
`2
`Internal data on file.
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`Contacts
`Foundation Medicine
`Lee-Ann Murphy, 617-245-3077
`pr@foundationmedicine.com
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`

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`Foundation Medicine
`Case 1:20-cv-01580-LPS Document 1-12 Filed 11/23/20 Page 5 of 5 PageID #: 470
`Abigail Alderman, 617-245-3077
`pr@foundationmedicine.com
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