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`FEBRUARY, 15, 2018
`
`The Guardant360® Assay Receives Expedited Access Pathway Designation for Breakthrough Devices
`from FDA
`
`REDWOOD CITY, Calif., Feb. 15, 2018 /PRNewswire/ -- The Guardant360® assay, the leading comprehensive liquid biopsy, received an Expedited Access
`Pathway (EAP) designation from the United States Food and Drug Administration, Guardant Health announced. If approved, the Guardant360 assay could be
`the first FDA-approved comprehensive liquid biopsy.
`
`"This marks a critical milestone for our work with the FDA, and an important moment in the development of comprehensive liquid biopsies," said Guardant
`Health Co-Founder and President AmirAli Talasaz. "This designation allows us to work hand in hand with the FDA as we prepare our submission to the FDA
`later this year. Accomplishing this goal will be critical as we deepen our capabilities for our partners in the biopharma industry."
`
`Guardant360 is a comprehensive liquid biopsy that helps oncologists select the optimal treatment for advanced cancer patients without the need for an invasive
`tissue biopsy. Guardant360 has been extensively validated and is supported by more than 20 clinical outcome studies. It is available in more than 30 countries.
`
`The Expedited Access Pathway is intended to speed review of breakthrough technologies and medical devices that serve unmet medical needs. Through the
`program, the FDA will work with Guardant Health to finalize its data development plan, providing access to senior FDA officials and facilitating a collaborative,
`cross-disciplinary review. The FDA is expected to replace the EAP soon with its new Breakthrough Devices Program. Premarket Approval Applications from
`EAP-designated devices typically receive priority review at the FDA, and all submissions designated as Breakthrough Devices are set to receive priority review.
`
`"Our FDA submission for Guardant360 is Guardant Health's top priority for 2018," said Guardant Health Co-Founder and CEO Helmy Eltoukhy. "The ability to
`tap into the FDA's expertise and support will be invaluable as we work toward our goal of seeking the first FDA approval for a comprehensive liquid biopsy."
`
`About Guardant Health
`Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular
`Skip to main content
`and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $500 million from leading
`investors. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially
`available and available in more than 30 countries. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early
`
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`Case 1:20-cv-01580-LPS Document 39-2 Filed 03/05/21 Page 3 of 89 PageID #: 7852
`detection, recurrence monitoring, and assessing minimal residual disease. Guardant Health and Guardant360 are registered trademarks of Guardant Health,
`
`Inc. Learn more at www.guardanthealth.com.
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`505 Penobscot Dr.
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`94063
`Telephone: 855.698.8887
`Fax: 888.974.4258
`Contact us:
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`Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration | Foun…
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`Foundation Medicine’s New Liquid Biopsy Assay Granted
`Breakthrough Device Designation by U.S. Food and Drug
`Administration
`
`CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 26, 2018-- Foundation Medicine, Inc.
`(NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA)
`granted a Breakthrough Device designation (formerly Expedited Access Pathway program)

`for its new liquid biopsy assay, which is an expanded version of its FoundationACT assay.
`e new assay will include more than 70 genes and genomic biomarkers for microsatellite
`instabili (MSI) and blood tumor mutational burden (bTMB). If approved, this test could be
`the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics
`(CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including
`immunotherapies.
`
`“Liquid biopsies are becoming an increasingly important option to inform personalized
`treatment decisions for patients with advanced cancer. A critical need exists for non-
`invasive solutions for these patients to help guide the use of both targeted and
`immunotherapies. Aer successlly completing the parallel review process with
`™
`FoundationOne CDx for solid tumors, we’re pleased to continue our work with the FDA
`applying this expertise to our liquid biopsy franchise with the potential to offer oncologists
`multiple FDA-approved options that enable biomarker-driven care and ultimately beer
`outcomes for patients,” said Vincent Miller, M.D., chief medical officer at Foundation
`https://www.foundationmedicine.com/press-releases/991ce685-7dbf-400a-aa33-eb4f9d411ed3
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`Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration | Foun…
`2/5/2021
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`Medicine. “e acceptance of this assay for Breakthrough Device designation is an
`important step to advancing precision medicine options for patients, including the potential
`intended use as a companion diagnostic across multiple pes of cancer, which will also
`help our biopharma partners accelerate their development efforts for these programs.”
`
`e new liquid biopsy assay is a next generation sequencing-based in-vitro diagnostic
`device for the detection of substitutions, insertion and deletion alterations (indels), copy
`number alterations (CNAs) and select gene rearrangements, as well as genomic signatures
`including microsatellite instabili (MSI) and blood tumor mutational burden (bTMB) using
`circulating cell-free DNA (cfDNA) isolated from plasma derived from peripheral whole
`blood. e company plans to seek approval of the assay for use as a companion diagnostic
`to identi patients who may benefit from treatment with certain targeted therapies in
`accordance with the approved therapeutic product labeling and to provide tumor mutation
`profiling to be used by qualified health care professionals following the professional
`guidelines in oncology for patients with malignant neoplasms.
`
`e FDA granted Foundation Medicine's request for Breakthrough Device designation
`because it met the criteria necessary for inclusion in the program, one of which is the large
`unmet medical need for comprehensive genomic profiling of tumors for cancer patients for
`whom a tissue sample is unavailable for testing. Under the Breakthrough Device Program,
`the FDA works with device sponsors to try to reduce the time and cost from development
`to an approval decision.
`
`About Foundation Medicine
`Foundation Medicine (NASDAQ:FMI) 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. e company offers a
`ll suite of comprehensive genomic profiling assays to identi 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 hp://.FoundationMedicine.com or follow Foundation
`
`https://www.foundationmedicine.com/press-releases/991ce685-7dbf-400a-aa33-eb4f9d411ed3
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`Medicine on Twier (@FoundationATCG).
`
`™


`Foundation Medicine and FoundationACT are registered trademarks and FoundationOneCDx
`is a trademark of Foundation Medicine, Inc.
`
`Cautionary Note Regarding Forward-Looking Statements for Foundation Medicine
`is press release contains "forward-looking statements" within the meaning of the Private
`Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the
`technical specifications of the company’s new liquid biopsy assay; the scope and timing of any
`approval of the liquid biopsy assay as a medical device by the FDA, including its potential approval
`and use as a companion diagnostic; the liquid biopsy assay’s abili to inform the use of targeted
`oncology therapies, including immunotherapies, or enhance patient access to targeted therapies and
`clinical trials; and any benefits provided by an FDA-approved version of the liquid biopsy assay,
`including benefits to patients, physicians or biopharma partners. All such forward-looking
`statements are based on management's current expectations of ture events and are subject to a
`number of risks and uncertainties that could cause actual results to differ materially and adversely
`from those set forth in or implied by such forward-looking statements. ese risks and uncertainties
`include the risks that the FDA does not approve the company’s new liquid biopsy assay as a medical
`device; the FDA is delayed in the completion of its review process; the liquid biopsy assay does not
`accelerate the development efforts of the company’s biopharma partners; and the risks described
`under the caption "Risk Factors" in Foundation Medicine's Annual Report on Form 10-K for the
`year ended December 31, 2017, which is on file with the Securities and Exchange Commission, as
`well as other risks detailed in subsequent filings with the Securities and Exchange Commission. All
`information in this press release is as of the date of the release, and Foundation Medicine
`undertakes no du to update this information unless required by law.
`
`View source version on businesswire.com:
`hps://.businesswire.com/news/home/20180426005504/en/
`
`Source: Foundation Medicine, Inc.
`
`Foundation Medicine, Inc.
`
`https://www.foundationmedicine.com/press-releases/991ce685-7dbf-400a-aa33-eb4f9d411ed3
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`Media:
`Lee-Ann Murphy, 617-245-3077
`pr@foundationmedicine.com
`or
`Investor:
`
`Kimberly Brown, 617-418-2215
`ir@foundationmedicine.com
`
`https://www.foundationmedicine.com/press-releases/991ce685-7dbf-400a-aa33-eb4f9d411ed3
`
`4/5
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`P RO D U C T S & S E RV I C E S
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`2/5/2021
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`Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration | Foun…
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`
`Laboratory Developed Tests
`
`A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used
`within a single laboratory.
`
`LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical
`compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. Some LDTs are relatively
`simple tests that measure single analytes, such as a test that measures the level of sodium. Other LDTs are complex
`and may measure or detect one or more analytes. For example, some tests can detect many DNA variations from a
`single blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can be
`measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium.
`
`While the uses of an LDT are often the same as the uses of FDA-cleared or approved in vitro diagnostic tests, some
`labs may choose to offer their own test. For example, a hospital lab may run its own vitamin D assay, even though
`there is an FDA-cleared test for vitamin D currently on the market.
`
`The FDA does not consider diagnostic devices to be LDTs if they are designed or manufactured completely, or
`partly, outside of the laboratory that offers and uses them.
`
`LDT’s are important to the continued development of personalized medicine, so it is important that in vitro
`diagnostics are accurate so that patients and health care providers do not seek unnecessary treatments, delay
`needed treatments, or become exposed to inappropriate therapies.
`
`FDA Activity
`
`The FDA has generally not enforced premarket review and other applicable FDA requirements because LDTs were
`relatively simple lab tests and generally available on a limited basis. Due to advances in technology and business
`models, LDTs have evolved and proliferated significantly since the FDA first obtained comprehensive authority to
`regulate all in vitro diagnostics as devices in 1976. Some LDTs are now much more complex, have a nationwide
`reach and present higher risks, such as detection of risk for breast cancer and Alzheimer’s disease, which are
`similar to those of other IVDs that have undergone premarket review.
`
`The FDA has identified problems with several high-risk LDTs including: claims that are not adequately supported
`with evidence; lack of appropriate controls yielding erroneous results; and falsification of data. The FDA is
`concerned that people could initiate unnecessary treatment or delay or forego treatment altogether for a health
`condition, which could result in illness or death. The FDA is aware of faulty LDTs that could have led to: patients
`being over- or undertreated for heart disease; cancer patients being exposed to inappropriate therapies or not
`getting effective therapies; incorrect diagnosis of autism; unnecessary antibiotic treatments; and exposure to
`unnecessary, harmful treatments for certain diseases such as Lyme disease.
`
`In 2010, the FDA announced its intent to reconsider its policy of enforcement discretion for LDTs and held a
`workshop to obtain input from stakeholders on such policy. FDA used this feedback to develop an initial draft
`approach for LDT oversight and published draft guidance in 2014. FDA solicited feedback on on the draft LDT
`framework (https://www.federalregister.gov/documents/2014/10/03/2014-23596/framework-for-regulatory-
`oversight-of-laboratory-developed-tests-draft-guidance-for-industry-food) and notification
`(https://www.federalregister.gov/documents/2014/10/03/2014-23586/food-and-drug-administration-
`notification-and-medical-device-reporting-for-laboratory-developed) guidances as well as held a public workshop.
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`Case 1:20-cv-01580-LPS Document 39-2 Filed 03/05/21 Page 14 of 89 PageID #: 7863
`In gathering feedback on the LDT draft guidances issued in 2014, we continuously engaged with interested
`stakeholders, including those groups that authored alternative proposals. We analyzed more than 300 sets of
`comments on the draft guidances and discussion from a subsequent public workshop held in 2015 as well as
`engaged in many meetings and conferences with various stakeholders. In the absence of issuing final guidance and
`at the request of stakeholders, we feel it is our responsibility to share our synthesis of all the feedback we have
`received, with the hope that it advances public discussion on future LDT oversight.
`
`To this end, on January 13, 2017, the FDA issued a discussion paper (/media/102367/download) on LDTs. The
`synthesis does not represent the formal position of FDA, nor is it enforceable. We hope to simply advance the
`public discussion by providing a possible approach to spur further dialogue.
`
`LDT Safety Information
`The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies – The real
`and potential harms to patients and to public health from certain laboratory developed tests (LDTs) –
`November 16, 2015 (http://wayback.archive-
`it.org/7993/20171114205911/https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm472773.htm)
` (http://www.fda.gov/about-fda/website-policies/website-disclaimer)
`LDT Public Workshops & Committees
`Public Workshop – Oversight of Laboratory Developed Tests, July 19-20, 2010
`(https://www.federalregister.gov/documents/2010/06/17/2010-14654/oversight-of-laboratory-developed-
`tests-public-meeting-request-for-comments)
`
`Reports to Congress
`Notification to Congress: FDA’s Laboratory Developed Tests Framework – July 31, 2014 (PDF - 991KB)
`(/media/89316/download)
`
`Related Links
`Blueprint for Breakthroughs - Charting the Course for Precision Medicine (/news-events/speeches-fda-
`officials/blueprint-breakthroughs-charting-course-precision-medicine-09132018)
`
`FDA Discussion Paper on Laboratory Developed Tests (LDTs) (PDF - 180KB) (/media/102367/download)
`
`FDA - Personalized Medicine (/precision-medicine)
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`
`FOUNDATION
`MEDICINE
`
`LOG M Q :
`'-
`
`
`
`AUGUST 26, 2020
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`SHARE
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`m
`
`FDA Approval Includes Companion Diagnostic Claimsfor Rubraca® (racaparib), the First PARP Inhibitor
`
`Approved in a Prostate Cancer Setting, and Three Tyrosine Kinase Inhibitorsfor Non-Small Cell Lung Cancer
`
`FoundationOne Liquid CDx Analyzes More Than 300 Genes and Genomic Signatures to Help Inform Treatment
`
`Decisionsfor all Solid Tumor Cancers
`
`Revised: 10/08/2020
`
`CAMBRIDGE, Mass. — (BUSINESS WIRE) —— Foundation Medicinefl today announced that the US.
`
`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:
`
`b
`
`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 (TKls) for the treatment of
`
`non—small cell lung cancer;
`
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`b
`
`an FDA—approved test to enable accelerated companion diagnostic development for biopharma
`
`companies developing precision therapeutics; and
`
`b
`
`a comprehensive genomic profiling test that reports genomic alteration results1 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. FoundationOne Liquid CD): 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
`
`beln inform nersnnalized treatment nlannina” said Andrea Ferris President and Chief F‘Xemltive
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`Case 1:20-cv-01580-LPS Document 39-2 Filed 03/05/21 Page 21 of 89 PageID #: 7870
`Case 1: 20-c—v-01580- LPS Document 39-2 Filed 03/05/21 Page 21 of 89 PageID #: 7870
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`"’
`
`Officer of LUNGevity Foundation.For many patients, getting a tissue biopsy1s not an option due to
`
`tumor location or the patients 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 sensitivity2 and specificity,3 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."
`
`As a laboratory professional service, which has not been reviewed or approved by FDA, the report also
`
`provides information about the genomic signatures microsatellite instability and blood tumor
`
`mutational burden, as well as single gene alterations, including NTRK fusions, to help inform the use
`
`of other therapies including immunotherapies. Also as a laboratory professional service the report
`
`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 available to order on Friday, August 28 at
`
`foundationmedicine.com(order, or visit f0undationmedicine.com[sign_up to register for an account.
`
`About FoundafionOne Liquid CDx
`
`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 (chNA) 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 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 armrnveri theranentir‘ nrndur‘t labelina Additinnal aennmir‘ findinos mav he rennrted and are nnt
`A0366
`
`FM1580-00046214
`
`A0366
`
`

`

`Case 1:20-cv-01580-LPS Document 39-2 Filed 03/05/21 Page 22 of 89 PageID #: 7871
`Case 1: 20-c—v- 01580- LPS Document 39-2 Filed 03/05/21 Page 22 of 89 PageID #: 7871
`““" ”1’17“" "" ”“"‘"’t"“”“’ I“""""""” "“""‘“ O' ‘ “”"M’M’u'" O‘““’“”” ““"u‘ O” “"‘J “'" L'va ""‘ ”u" “L" ““"’
`
`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 refiexed 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 W.F1LCDXLab€l.C0m.
`
`FoundationOne Liquid CDX is indicated for use as a companion diagnostic for:
`
`Tumor Type
`
`Biomarker(s) Detected
`
`Therapy
`
`Non—small cell lung EGFR Exon 19 deletions and
`.
`_
`EGFR Exon 21 L858R subst1tut1on
`
`cancer (NSCLC)
`
`IRESSA® (gefitinib)
`
`TAGRISSO® (osimertinib)
`
`TARCEVA® (erlotinib)
`
`Metastatic
`
`castration—resistant
`
`prostate cancer
`
`(mCRPC)
`
`ERG/l1, ERG/l2 alterations
`
`,,
`RUBRACA® (rucaparib)
`
`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
`
`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 WFoundationMedicinecom or follow Foundation Medicine on Twitter
`
`(@medatinn ATCGl
`
`A0367
`
`FM1580-00046215
`
`A0367
`
`

`

`Case 1:20-cv-01580-LPS Document 39-2 Filed 03/05/21 Page 23 of 89 PageID #: 7872
`Case 1:20-cv-01580-LPS Document 39-2 Filed 03/05/21 Page 23 of 89 PageID #: 7872
`
`yam—‘-v '“*‘”*""*V‘** *e“ “W v]-
`
`Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
`
`Rubraca® is a registered trademark of Clovis Oncology, Inc.
`
`Iressa® and Tagrisso® are registered trademarks of the AstraZeneca AB Corporation.
`
`Tarceva® is a registered trademark of OSI Pharmaceuticals, LLC.
`
`1 As part of the FDA—approved intended use, short variants (substitutions and insertion/deletions) are
`
`reported in 311 genes, and rearrangements and copy number losses are reported in BRCA1 and
`
`BRCA2. As a professional service, not approved by FDA, rearrangements are reported in 324 genes
`
`and copy number amplifications are reported in 310 genes.
`
`2 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.
`
`3 0% false positive rate for rearrangements and copy number alterations, 0.013% false positive rate for
`
`substitutions and indels. Internal data on file.
`
`Media Contacts:
`
`Foundation Medicine
`
`Lee—Ann Murphy, 617—245—3077
`
`m@foundationmedicine.com
`
`Foundation Medicine
`
`Abigail Alderman, 617—245—3077
`
`m@foundationmedicine.com
`
`Source: Foundation Medicine
`
`A0368
`
`FM1580-00046216
`
`A0368
`
`

`

`Case 1:20-cv-01580-LPS Document 39-2 Filed 03/05/21 Page 24 of 89 PageID #: 7873
`Case 1

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