Case 1:20-cv-01644-RGA Document 1-35 Filed 12/03/20 Page 1 of 4 PageID #: 1014
`Case 1:20-cv-01644-RGA Document 1-35 Filed 12/03/20 Page 1 of 4 PageID #: 1014
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`EXHIBIT 35
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`EXHIBIT 35
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`10/28/2020
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`Press Release
`Case 1:20-cv-01644-RGA Document 1-35 Filed 12/03/20 Page 2 of 4 PageID #: 1015
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`News Center / Press Releases:
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`PRESS RELEASE
`
`Illumina Introduces Expanded
`Version of VeriSeq™ NIPT
`Solution, Offering More
`Comprehensive Detection of
`Rare Chromosomal Conditions
`
`Next-generation Sequencing-based Solution Provides Accurate, Fast and Scalable
`End-to-end Genome-wide Noninvasive Prenatal Testing
`
`SAN DIEGO--(BUSINESS WIRE)--Jun. 4, 2019-- Illumina, Inc. (NASDAQ: ILMN) today
`announced the launch of VeriSeq NIPT Solution v2, a CE-IVD, next-generation
`™
`sequencing (NGS)-based approach to noninvasive prenatal testing (NIPT). The
`automated comprehensive solution allows laboratories to screen for a broader range
`of chromosomal and sub-chromosomal conditions associated with birth defects and
`adverse pregnancy outcomes than the standard NIPT menu. VeriSeq NIPT Solution
`v2 delivers the most comprehensive view of the fetal genome compared to other CE-
`IVD NIPT products, enabling healthcare providers to support expectant parents with
`informed, timely and personalized pregnancy management options better than ever
`before. VeriSeq NIPT Solution v2 is now available across most countries in Europe, as
`
`well as South Africa. Product registration is pending in Australia, Israel and New
`Zealand.
`
`This press release features multimedia. View the full release
`here:https://www.businesswire.com/news/home/20190604005234/en/
`
`VeriSeq NIPT
`
`Solution v2 provides
`accurate
`information about
`fetal chromosomal
`status as early as 10
`weeks of gestation
`using a single
`maternal blood
`draw. This
`noninvasive test
`provides an option
`to screen for
`aneuploidy in all
`autosomes,
`chromosomes X & Y, and partial deletions and duplications greater than 7 Mb across
`the genome. Due to its high-sensitivity and high-specificity (low false-positive and
`false-negative rates), NGS-based NIPT minimizes the need for invasive testing
`
`VeriSeq NIPT Solution v2 (Photo: Business Wire)
`
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`10/28/2020
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`Press Release
`Case 1:20-cv-01644-RGA Document 1-35 Filed 12/03/20 Page 3 of 4 PageID #: 1016
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`procedures. The automated, reliable solution provides reagents, instruments,
`installation and training, and offers unprecedented turnaround times; laboratories can
`process up to 96 samples in approximately one day.
`
`“Genome‐wide cell-free DNA screening allows not only for the detection of common
`chromosomal aneuploidies, but also enables the identification of rare autosomal
`aneuploidies (RAAs), as well as partial deletions and duplications that are ≥7 Mb in
`size. Most RAAs are non-viable and result in a miscarriage. However, in the mosaic
`state they may persist and result in congenital malformations, intellectual disabilities,
`growth restriction, unfavorable pregnancy outcome, as well as fetal uniparental
`disomy,” said Professor Yuval Yaron, Director of the Prenatal Genetic Diagnosis Unit
`at the Tel Aviv Sourasky Medical Center. “Furthermore, the karyotype-like resolution
`enables the detection of pathogenic copy number variants (CNVs). While many
`smaller CNVs may ultimately be classified as variants of unclear significance, virtually
`all CNVs ≥7 Mb in size will be classified as pathogenic, even in fetuses with no
`discernable malformations.”
`
`The clinical accuracy of VeriSeq NIPT Solution v2, with respect to outcomes
`determined by a clinical reference standard assessment, was demonstrated by
`evaluating more than 2,300 plasma samples from pregnant women with singleton
`and twin pregnancies undergoing prenatal screening for fetal chromosome
`aneuploidies and partial deletions and duplications of 7 Mb or greater. The study
`determined that VeriSeq NIPT Solution v2 provided highly sensitive and specific
`results – 98.8 percent passed assay quality control on the first pass.
`
`“By leveraging Illumina paired-end sequencing by synthesis chemistry and
`incorporating innovations in workflow, instruments and software, VeriSeq NIPT
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`Solution v2 makes NGS-based NIPT accessible to any laboratory,” said Garret
`Hampton, Senior Vice President of Clinical Genomics at Illumina. “We’re thrilled to
`provide a differentiated and reliable NIPT solution that provides more information to
`healthcare providers and expectant parents about the genetic health of a baby.”
`
`Click here for more information on VeriSeq NIPT Solution v2.
`
`About Illumina, Inc.
`
`Illumina is improving human health by unlocking the power of the genome. Our focus
`on innovation has established us as the global leader in DNA sequencing and array-
`based technologies, serving customers in the research, clinical, and applied markets.
`Our products are used for applications in the life sciences, oncology, reproductive
`health, agriculture, and other emerging segments. To learn more,
`visit www.illumina.com and follow @illumina.
`
`Forward-Looking Statements
`
`This release contains forward-looking statements that involve risks and uncertainties.
`Examples of forward-looking statements include, but are not limited to, statements
`we make regarding the expected availability dates for, and field performance of, new
`products and services. Important factors that could cause actual results to differ
`materially from those in any forward-looking statements include challenges inherent
`in developing, manufacturing, and launching new products and services, and the
`other factors that are detailed in our filings with the Securities and Exchange
`Commission, including our most recent filings on Forms 10-K and 10-Q, or in
`information disclosed in public conference calls, the date and time of which are
`released beforehand. We do not intend to update any forward-looking statements
`after the date of this release.
`
`View source version on businesswire.com:
`https://www.businesswire.com/news/home/20190604005234/en/
`
`https://www.illumina.com/company/news-center/press-releases/press-release-details.html?newsid=8e4a1ea5-47f8-4bb4-b061-c07275fb0070
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`10/28/2020
`
`Press Release
`Case 1:20-cv-01644-RGA Document 1-35 Filed 12/03/20 Page 4 of 4 PageID #: 1017
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`Source: Illumina, Inc.
`
`Investors:
`Jacquie Ross, CFA
`+1 (858) 882-2172
`ir@illumina.com
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`Media:
`Karen Birmingham (Europe)
`+44(0) 7500105665
`kbirmingham@illumina.com
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`Tina Amirkiai (USA)
`+1 (858) 882-6822
`pr@illumina.com
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`Innovative technologies
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`At Illumina, our goal is to apply innovative technologies to the analysis of genetic variation and function, making
`studies possible that were not even imaginable just a few years ago. It is mission critical for us to deliver
`innovative, flexible, and scalable solutions to meet the needs of our customers. As a global company that places
`high value on collaborative interactions, rapid delivery of solutions, and providing the highest level of quality, we
`strive to meet this challenge. Illumina innovative sequencing and array technologies are fueling groundbreaking
`advancements in life science research, translational and consumer genomics, and molecular diagnostics.
`For Research Use Only. Not for use in diagnostic procedures (except as specifically noted).
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