`Case 1:20-cv-01644-RGA Document 1-44 Filed 12/03/20 Page 1 of 3 PageID #: 1259
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`EXHIBIT 44
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`EXHIBIT 44
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`10/28/2020
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`In-Lab Screening with NIPT | Turnkey sample-to-results in your lab
`Case 1:20-cv-01644-RGA Document 1-44 Filed 12/03/20 Page 2 of 3 PageID #: 1260
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`23 CHROMOSOME PAIRS
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`AND MORE
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`Rethink prenatal screening.
`Think VeriSeq NIPT.
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`View Video
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`Clinical / Reproductive and Genetic Health / Noninvasive Prenatal Testing (NIPT):
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`NIPT has never performed better
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`99.9%
`>
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`26
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`98.8%
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`ACCURACY FOR T21, T18, T13
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`HOURS
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`FIRST PASS SUCCESS
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`Superior performance. More confidence.
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`It’s time to change the way you think about prenatal testing. The VeriSeq
`NIPT Solution v2 offers superior performance to any in vitro diagnostic
`(IVD) noninvasive prenatal testing (NIPT) solution available. With a
`sensitivity and specificity of >99.9% for trisomies 21, 18, and 13, a start-to-
`finish run time of just 26 hours, and a low sample failure rate, you can feel
`the confidence that comes with superior performance.
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`Beyond performance, VeriSeq NIPT Solution v2 also offers coverage
`across the entire fetal genome, with the option to screen for aneuploidy for
`all chromosomes and partial duplications and deletions of 7 Mb or higher
`for all autosomes. Most NIPTs only give information on the status of
`common aneuploidies of chromosomes 21, 18, and 13. You may be missing
`something if you’re not looking genome-wide.
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`Bring VeriSeq NIPT Solution into my Lab
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`Learn More about NIPT Sendout for Labs
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`1 T
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`SOLUTION
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`he PCR-free, automated and validated workflow is CE-
`marked and fully integrated from sample prep to NextSeq
`550Dx Sequencing System to assay software. With a
`comprehensive IVD solution, you have everything you need
`for NIPT using NGS. Watch how the VeriSeq NIPT Solution
`can take you from sample to results with an automated end-
`to-end workflow.
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`View Video
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`https://www.illumina.com/clinical/reproductive-genetic-health/nipt/in-lab-screening.html
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`In-Lab Screening with NIPT | Turnkey sample-to-results in your lab
`Case 1:20-cv-01644-RGA Document 1-44 Filed 12/03/20 Page 3 of 3 PageID #: 1261
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`Additional Resources
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`The Clinical Value of NIPT
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`NIPT Technology Guide
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`Learn how noninvasive prenatal testing
`(NIPT) is making an impact around the
`world.
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`Learn more about NIPT and key
`considerations when selecting a
`technology for screening with NIPT.
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`Understanding the VeriSeq NIPT
`Solution Assay
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`Dive into the VeriSeq NIPT assay and learn
`how it works.
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`View Video
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`Download Guide
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`View Video
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`Intended Use
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`The VeriSeq NIPT Solution v2 is an in vitro diagnostic test intended for use as a screening test for the detection of genome-wide fetal genetic anomalies from maternal peripheral
`whole blood specimens in pregnant women of at least 10 weeks gestation. VeriSeq NIPT v2 uses whole-genome sequencing to detect partial duplications and deletions for all
`autosomes and aneuploidy status for all chromosomes. The test offers an option to request the reporting of sex chromosome aneuploidy (SCA). This product must not be used as the
`sole basis for diagnosis or other pregnancy management decisions.
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`Limitations of the test
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`Noninvasive prenatal testing (NIPT) based on cell-free DNA analysis from maternal blood is a screening test; it is not diagnostic. False positive and false negative results do occur.
`Test results must not be used as the sole basis for diagnosis. Further confirmatory testing is necessary prior to making any irreversible pregnancy decision. A negative result does not
`eliminate the possibility that the pregnancy has a chromosomal or sub chromosomal abnormality. This test does not screen for polyploidy (eg, triploidy), birth defects such as open
`neural tube defects, single gene disorders, or other conditions, such as autism. There is a small possibility that the test results might not reflect the chromosomal status of the fetus,
`but may instead reflect chromosomal changes in the placenta (confined placental mosaicism, CPM) or the mother that may or may not have clinical significance.
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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 In Vitro Diagnostic Use. Not available in all countries and regions.
`
`Contact an Illumina representative for regional availability.
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`For specific trademark information, see www.illumina.com/company/legal.html.
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