`Case 1:20-cv-01580-LPS Document 9-7 Filed 12/10/20 Page 1 of 7 PageID #: 1040
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`EXHIBIT 7
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`EXHIBIT 7
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`Case 1:20-cv-01580-LPS Document 9-7 Filed 12/10/20 Page 2 of 7 PageID #: 1041
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`A New Decade of Possibili for Precision
`Oncology
`
`Cindy Pere ie
`
`Foundation Medicine has a clear and ambitious goal – to transform oncology and redefine
`the way each person with cancer is treated. We believe all patients deserve the highest
`quali , actionable genomic information to inform and optimize their individual treatment
`plan. And there are two important elements to this that define our approach to precision
`oncology and help guide our path forward.
`
` e first is access, and by this, I mean delivering the tools necessary to open up the benefits
`of precision oncology to as many patients as possible, as rapidly as possible.
`
` e second equally important element is quali . In such a rapidly evolving and complex
`treatment landscape, it’s vital that physicians are confident in the insights that they
`receive from genomic analysis to inform the decisions about treatment
`approaches they choose for their patients.
`
`Ensuring advanced cancer patients have access to high quali genomic information about
`their cancer is what drives our path forward; a path that delivers progress and options for
`patients now while creating the benchmarks and se ing the standards for precision
`
`BACK TO BLOG
`AUGUST 27, 2020
`CEO, Foundation Medicine
`SHARE
`LO G I N
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`Case 1:20-cv-01580-LPS Document 9-7 Filed 12/10/20 Page 3 of 7 PageID #: 1042
`oncology in the ture.
`
`For me, our latest step forward is a true demonstration of our approach in action;
`yesterday’s announcement of the U.S. Food and Drug Administration (FDA) approval of
`FoundationOne®Liquid CDx, our comprehensive pan-tumor liquid biopsy test along with
`multiple companion diagnostic claims. From a simple blood draw,
`FoundationOne®Liquid CDx analyzes over 300 genes for alterations known to drive cancer
`growth and within the professional services section of our report, includes information on
`genomic signatures, including high microsatellite instabili (MSI) status and blood tumor
`mutational burden (bTMB), as well as all NTRK sions, arming physicians and patients
`with deep molecular insights to guide informed decisions on the potential use of targeted
`therapies, clinical trials or immunotherapy as part of their individual treatment plan.
`
`Not only is FoundationOne Liquid CDx the most comprehensive FDA-approved liquid
`biopsy test of its kind to help physicians make informed decisions about personalized
`treatment, regardless of cancer pe, but it has also been granted coverage for eligible
`Medicare and Medicare Advantage beneficiaries by the Centers for Medicare and Medicaid
`Services (CMS) and will be commercially available tomorrow. is is an important step
`forward in expanding access to precision medicine for eligible patients with advanced
`cancer.
`
`Reaching this point, where we can offer patients the broadest FDA-approved CGP liquid
`biopsy test with multiple companion diagnostic claims is the result of several years of
`research and collaboration to evolve the science and help establish the clinical utili of
`liquid biopsy in patient care. And, while tissue samples remain incredibly important for
`understanding the genomic drivers of a patient’s cancer, every patient is different
`and unfortunately, for many, a tissue biopsy is not an option.
`
`If you look at non-small cell lung (NSCLC) cancer for example, approximately 30 percent of
`patients do not have enough tissue available for testing. And, regardless of tissue
`availabili , patients with advanced cancer are sometimes too unwell to cope with
`a tissue biopsy procedure, an additional barrier to accessing the benefits of precision
`l i
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`An important option for advanced cancer patients
`
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`Case 1:20-cv-01580-LPS Document 9-7 Filed 12/10/20 Page 4 of 7 PageID #: 1043
`oncology. ere is a critical need for minimally invasive methods to connect these patients
`to genomic insights that could match them to targeted treatment, and in cases where there
`is not enough circulating tumor DNA in a patient’s blood sample, our portfolio
`approach allows physicians to reflex, or switch, to a FoundationOne CDx tissue test.
`
`Approximately 50 percent of new cancer drugs in development are projected to have a
`1
`companion biomarker. And, as these new biomarker driven therapies become available,
`we’re seeing an increased need for coinciding companion diagnostic tests to identi
`patients eligible for these treatments.
`
`Companion diagnostics tests are incredibly important for matching patients with FDA-
`approved targeted therapies and are essential for the safe and effective use of these
`treatments. is is why we’re proud that FoundationOne Liquid CDx is also an FDA-
`approved companion diagnostic for four targeted cancer therapies, which meet critical
`needs in lung and prostate cancer. One of these therapies was the first PARP inhibitor
`approved for patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate
`Cancer (mCRPC), and now, with an FDA approved liquid companion diagnostic, healthcare
`professionals can identi patients eligible for this treatment through a simple blood draw.
`
`And, as we continue to work with our biopharma partners, FoundationOne Liquid CDx
`will serve as an important, FDA-approved, pan tumor platform for developing companion
`diagnostics to help advance their clinical programs, understand mechanisms of
`resistance and accelerate the development of new targeted therapies.
`
`Foundation Medicine was proud to pave the way for regulatory approvals of this kind
`
`when we took our flagship test, FoundationOne CDx, through the approval process withflags
`the FDA in 2017. e industry standards for genomic testing that we created through
`this process ensure patients and their physicians are receiving the highest quali genomic
`information available. at’s why today’s approval is such an important milestone. We can
`ff
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`Delivering actionable insights
`A framework for the future of oncology
`
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`Case 1:20-cv-01580-LPS Document 9-7 Filed 12/10/20 Page 5 of 7 PageID #: 1044
`now offer oncologists multiple FDA-approved, high-quali comprehensive genomic
`profiling options that allow them to bring biomarker-driven care to even more patients
`than before. And, our biopharma partners, another FDA-approved platform – beyond our
`tissue-based assay – for companion diagnostic development to advance their therapeutic
`programs.
`
`At Foundation Medicine, we believe that continued collaboration and innovation is vital to
`ensuring more patients are able to realize the benefits of precision medicine. And, as
`
`we celebrate our ten-year anniversary as a company, we remain commi ed to working
`together to bring these pes of breakthroughs to patients.
`
`[1] Developments in Cancer Treatments, Market Dynamics, Patient Access and Value - Global Oncology Trend Report
`
`2015. IMS Institute for Healthcare Informatics.
`
`Cindy Perettie
`CEO, Foundation Medicine
`Cindy Perettie joined Foundation Medicine in February 2019 as its Chief Executive Officer. Ms.
`Perettie is passionate about improving the care of cancer patients and brings more than two
`decades of scientific and commercial experience with global biopharmaceutical organizations. Prior
`to joining Foundation Medicine, Ms. Perettie served as senior vice president in global oncology
`product strategy for Roche’s Oncology unit, where she led one of the largest global oncology
`portfolios in the industry.
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`Case 1:20-cv-01580-LPS Document 9-7 Filed 12/10/20 Page 6 of 7 PageID #: 1045
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`Liquid Biopsy: From an Improbable Idea, New
`Potential Emerges
`
`Liquid Biopsy: From an Improbable Idea, New Potential Emerges
`
`Liquid Biopsy
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`Case 1:20-cv-01580-LPS Document 9-7 Filed 12/10/20 Page 7 of 7 PageID #: 1046
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