Case 1:20-cv-01580-LPS Document 1-11 Filed 11/23/20 Page 1 of 3 PageID #: 463
`Case 1:20-cv-01580-LPS Document 1-11 Filed 11/23/20 Page 1 of 3 PageID #: 463
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`EXHIBIT 11
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`EXHIBIT 11
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`Case 1:20-cv-01580-LPS Document 1-11 Filed 11/23/20 Page 2 of 3 PageID #: 464
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`Foundation Medicine Introduces FoundationOne Liquid, the Latest
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`Advance in the Company’s Liquid Biopsy Test for Solid Tumors in
`Patients with Advanced Cancer
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`– FoundationOne Liquid analyzes 70 genes known to drive cancer growth and reports
`microsatellite instability high (MSI-high) status to inform the use of precision oncology
`treatments, including immunotherapies, with a simple blood draw –
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`September 24, 2018 01:00 AM Eastern Daylight Time
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`CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced that FoundationOne Liquid, its next-
`generation liquid biopsy test for solid tumors, is commercially available in the United States. Using a blood sample,
`FoundationOne Liquid analyzes 70 genes known to drive cancer growth, including homologous recombination deficiency (HRD)
`1
`genes, and reports the genomic biomarker for microsatellite instability (MSI), to help inform the use of checkpoint inhibitor
`immunotherapies and multiple targeted therapies, including poly (ADP-ribose) polymerase (PARP) inhibitors, as well as clinical
`trials for patients with advanced cancer.
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`“With the commercial launch of FoundationOne Liquid, we are further expanding access to important genomic information that
`has the potential to match more patients to targeted therapies,” said Tom Civik, Chief Commercial Officer at Foundation Medicine.
`“For many cancer patients, traditional tissue testing is not feasible, and there is a pressing need for minimally invasive solutions to
`help inform personalized treatment decisions. FoundationOne Liquid meets our highest standards for sensitivity and analytical
`validation and offers providers additional insights to help guide treatment options, including immunotherapies and PARP
`inhibitors. In addition to the clinical advancements this test provides, it will also help our biopharma partners improve trial design
`and accelerate drug development.”
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`FoundationOne Liquid is a hybrid capture-based, next-generation sequencing in vitro diagnostic device for the detection of
`substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements using
`circulating cell-free DNA (cfDNA) isolated from plasma derived from peripheral whole blood. The FoundationOne Liquid test
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`expands upon the previous version of the Company’s liquid biopsy test, FoundationACT , which has been analytically validated
`across the four main classes of genomic alterations. Evaluation of the platform using multiple validation methods across a broad
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`range of tumor types demonstrated high sensitivity and positive predictive value , even at the low allele frequencies often
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`observed in clinical samples.
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`“This is an important new option for metastatic cancer patients with insufficient tumor tissue specimens or for those at risk for
`invasive biopsy,” said Tianhong (Tina) Li, MD, PhD, University of California Davis Comprehensive Cancer Center.
`“FoundationOne Liquid expands the ability of clinicians to select the most appropriate cancer therapy based on individual
`patients’ molecular and immune biomarker profile at initial diagnosis and as the disease progresses.”
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`FoundationOne Liquid represents the latest advance in Foundation Medicine’s long-standing commitment to develop innovative
`liquid biopsy technologies. In April 2018, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device
`Case 1:20-cv-01580-LPS Document 1-11 Filed 11/23/20 Page 3 of 3 PageID #: 465
`designation for the Company’s liquid biopsy assay currently in development that includes the genomic biomarker blood tumor
`mutational burden (bTMB). If approved, this forthcoming test could be the first FDA-approved liquid biopsy test to incorporate
`multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including
`immunotherapies.
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`FoundationOne Liquid can also be used to complement prior tissue-based testing methods, providing results with longitudinal
`comparisons to previous Foundation Medicine test results. Foundation Medicine offers an option to automatically reflex to
`FoundationOne Liquid if tissue is insufficient for tissue-based testing. Healthcare providers can order a FoundationOne Liquid kit
`online at www.foundationmedicine.com/genomic-testing/foundation-one-liquid/order-kit, or visit
`www.foundationmedicine.com/genomic-testing/foundation-one-liquid to learn more.
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`About Foundation Medicine
`
`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 tests 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).
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`Foundation Medicine , FoundationOne Liquid, and FoundationACT are registered trademarks of Foundation Medicine, Inc.
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` MSI status will be reported for samples determined to have high microsatellite instability.
` >99% sensitivity for base substitutions, indels and rearrangements at >0.5% mutant allele frequency (MAF). Sensitivity for copy
`number variations is >95% when the tumor fraction is ≥20%. Internal data on file.
` >99% PPV for all alterations, calculated as a weighted average of the PPV for each class of alteration, with the weighting based
`upon the frequency with which FoundationACT detects each class of alteration. The PPV for copy number variations at ≥20%
`tumor fraction is 97.6%. Internal data on file.
` Clark et al. Analytical validation of a hybrid capture-based next-generation sequencing clinical assay for genomic profiling of
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`cell-free circulating tumor DNA. The Journal of Molecular Diagnostics. 2018. doi: https://doi.org/10.1016/j.jmoldx.2018.05.004
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`Contacts
`Foundation Medicine
`Lee-Ann Murphy, 617-245-3077
`pr@foundationmedicine.com
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