`Case 1:20-cv-01644-RGA Document 1-34 Filed 12/03/20 Page 1 of 3 PageID #: 1011
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`EXHIBIT 34
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`EXHIBIT 34
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`11/6/2020
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`Press Release
`Case 1:20-cv-01644-RGA Document 1-34 Filed 12/03/20 Page 2 of 3 PageID #: 1012
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`PRESS RELEASE
`
`Illumina Launches the
`VeriSeq™ NIPT Solution in
`Europe
`
`NGS-based Solution Makes Fast, Highly Accurate, Cost-effective Noninvasive
`Prenatal Testing Available to EU Labs
`
`SAN DIEGO--(BUSINESS WIRE)--Apr. 10, 2017-- Illumina, Inc. (NASDAQ: ILMN) today
`announced the launch of the VeriSeq NIPT Solution, a CE-IVD marked next-
`™
`generation sequencing (NGS)-based approach to noninvasive prenatal testing
`(NIPT), including CE-IVD marked library prep and analysis software, which enables
`laboratories in the European Union to bring efficient, highly accurate NIPT in-house.
`The automated comprehensive solution allows laboratories to screen for certain fetal
`chromosomal abnormalities in approximately one day.
`
`This Smart News Release features multimedia. View the full release
`here:http://www.businesswire.com/news/home/20170409005007/en/
`
`VeriSeq™ NIPT Solution (Photo: Business Wire)
`
`The VeriSeq NIPT
`™
`Solution provides
`accurate
`information about
`fetal chromosome
`status as early as 10
`weeks gestation
`using a single
`maternal blood
`draw. This noninvasive screen yields results for trisomy 21 (Down syndrome), trisomy
`18 (Edwards syndrome), trisomy 13 (Patau syndrome), as well as certain sex
`chromosome-related disorders. Due to its high-sensitivity and high-specificity (low
`false-positive and false-negative rates), NGS-based NIPT minimizes the need for
`invasive testing procedures.
`
`"As a proud partner of Illumina, we are thrilled to soon use the new VeriSeq NIPT
`™
`protocol to power our NIPT test, Serenity,” said Tony Gordon, PhD, Vice President of
`Business Development for CooperGenomics. "The advances offered by
`VeriSeq NIPT will allow us to provide results to our clinical partners faster, with high
`™
`sensitivity and minimal test failures.”
`
`By leveraging Illumina paired-end sequencing by synthesis chemistry and
`incorporating innovations in workflow, instruments and software, the VeriSeq NIPT
`™
`Solution makes NGS-based NIPT accessible to any laboratory. 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. To demonstrate performance, Illumina conducted a rigorous
`supporting clinical accuracy study of over 3,100 maternal samples which determined
`that the VeriSeq NIPT Solution not only provided highly sensitive and specific results
`™
`for trisomies 21, 13 and 18, but also demonstrated a high concordance for the sex
`chromosomal aneuploidies reported.
`
`“The VeriSeq NIPT Solution offers a rapid workflow and unprecedented automation
`™
`that revolutionizes NIPT. With this validated, CE-IVD marked solution featuring CE-
`IVD library prep and analysis software, customers can now access highly reliable
`NGS-based NIPT in their own labs,” said Jeff Hawkins, Vice President and General
`
`https://www.illumina.com/company/news-center/press-releases/press-release-details.html?newsid=d6bf8efa-3be8-45a8-8f41-450b4e531002
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`Press Release
`Case 1:20-cv-01644-RGA Document 1-34 Filed 12/03/20 Page 3 of 3 PageID #: 1013
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`Manager of Reproductive Genetic Health at Illumina. “With this new solution,
`laboratories can feel confident that they are providing expectant parents with a
`highly reliable technology that enables accurate results.”
`
`The VeriSeq NIPT Solution is available for order and is now shipping. For more
`™
`information, visit www.illumina.com/VeriSeqNIPTEU.
`
`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 new products and services
`and FDA submission dates and intentions for certain 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:
`http://www.businesswire.com/news/home/20170409005007/en/
`
`Source: Illumina, Inc.
`
`Illumina, Inc.
`Investors:
`Rebecca Chambers
`858-255-5243
`ir@illumina.com
`or
`Media:
`David Robertson
`+44 (0)1223.824909
`pr@illumina.com
`or
`Tina Amirkiai
`858-882-6822
`pr@illumina.com
`
`Innovative technologies
`
`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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