Case 1:20-cv-01580-LPS Document 9-3 Filed 12/10/20 Page 1 of 4 PageID #: 855
`Case 1:20-cv-01580-LPS Document 9-3 Filed 12/10/20 Page 1 of 4 PageID #: 855
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`EXHIBIT 3
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`EXHIBIT 3
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`Case 1:20-cv-01580-LPS Document 9-3 Filed 12/10/20 Page 2 of 4 PageID #: 856
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`IMMUNO-ONCOLOGY RESEARCH, CANCER RESEARCH, CORPORATE,
`ONCOLOGY
`
`The Power and Promise of
`Liquid Biopsies
`By: Dr. Phil Febbo, Chief Medical Officer at Illumina
`
`RECENT ARTICLES
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`November 6, 2019
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`Tumor tissue diagnostic biopsies are a critical component in cancer care. These
`valuable samples confirm whether a patient has cancer, provide a snapshot of the
`tumor-host microenvironment, and help determine a malignancy’s potential
`aggressiveness. Digitized pathology images and advanced analytics offer even more
`information from biopsies, especially when histological data is complemented with
`targeted molecular information through immunohistochemistry (IHC) and other
`means. Add in next generation sequencing (NGS), which provides comprehensive
`molecular insights, and the information from biopsies further improves risk
`stratification, identifying specific mutations and genomic markers that can predict
`therapeutic benefit.
`
`Still, surgical biopsies have their drawbacks. First, they are invasive. We think of
`biopsies as relatively minor operations, but such procedures can be serious. As a
`result, biopsies can be challenging to perform, and repeated biopsies over time to
`monitor cancer progression and optimize therapies are seldom feasible. We usually
`get an initial diagnostic biopsy and, sometimes, a second upon spread or
`progression.
`
`Even when accessible, any single biopsy sample may not represent an entire tumor
`due to cancer heterogeneity. Mutations can be localized to different regions, and
`tumors often include varied proportions of different clones. One tissue sample from a
`single region will rarely capture the full complexity of an individual’s cancer.
`
`

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`Case 1:20-cv-01580-LPS Document 9-3 Filed 12/10/20 Page 3 of 4 PageID #: 857
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`Even with our incredible tissue biopsy analysis advances, accessibility challenges
`and tumor heterogeneity demand complementary solutions to evaluate tumors more
`frequently and comprehensively.
`
`That’s why many, including myself, are enthusiastic about liquid biopsies, which can
`provide crucial molecular information with simple blood draws. As cancers grow, they
`slough off cells, cell fragments, and DNA from apoptotic or necrotic cancer cells,
`which enter the blood stream and offer tremendous opportunities to better assess
`cancer.
`
`Though we’re only beginning to understand how to use this information to optimize
`patient outcomes, blood samples are already outlining cancer aggressiveness,
`identifying treatment options, tracking efficacy, and precisely managing each
`patient’s unique disease.
`
`As NGS costs decrease, and our understanding of cell-free RNA, circulating tumor
`cells and exosomes increase, these diagnostics will provide even more powerful
`information to guide treatment.
`
`Our current focus on targetable mutations will soon include genome-wide signatures,
`such as DNA repair issues and epigenetic markers, which can provide additional
`information to describe a cancer’s tissue of origin, metastasis location and other key
`metrics.
`
`Because liquid biopsies interrogate cell-free DNA (cfDNA) from an entire tumor (or
`tumors), rather than a single tissue sample, they can provide more comprehensive
`information about their makeup to more fully capture mutational complexity.
`
`Single-cell analyses will help identify clonal populations, and can find commonly
`shared cancer-driving mutations as well as collections of variants that represent
`most clones in order to enable highly effective, bespoke immunotherapies.
`
`In the near future, cfDNA will help us refine a patient’s risk of recurrence and detect
`recurrence earlier than radiology. While some are appropriately skeptical that earlier
`recurrence detection will benefit patients, I am quite bullish. As more effective
`therapies emerge, our ability to treat recurrent disease earlier will translate into
`improved outcomes. I predict we will see a growing number of clinical studies to test
`this optimism.
`
`As we make progress towards using liquid biopsies to better manage patients with
`later-stage cancers, we are simultaneously developing tests that detect tumors
`during their earliest stages, when they are most treatable. In this vision, liquid
`biopsies could be part of a standard annual physical, like cholesterol and blood
`glucose tests.
`
`While screening success requires strong evidentiary support, success would shift the
`stage at which patients are diagnosed. More people will be diagnosed at stages 1
`and 2 – while the objective is treatment for cure – rather than stage 3 or 4. Stage
`migration in ovarian, pancreatic, lung, and other cancers would result in improved
`outcomes.
`
`Liquid biopsies will continue to advance. In the near future, we will move from single-
`sample analyses that provide only one, transitory snapshot of a tumor’s progression,
`to longitudinal studies that track cancer over time. This technology, combined with
`targeted therapies, immunotherapies, and other emerging approaches, will ultimately
`help us cure many patients.
`
`Read about Illumina's new liquid biopsy and high-throughput assays in the TruSight
`portfolio here. 
`
`

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`Case 1:20-cv-01580-LPS Document 9-3 Filed 12/10/20 Page 4 of 4 PageID #: 858
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