Case 1:20-cv-01644-RGA Document 1-43 Filed 12/03/20 Page 1 of 4 PageID #: 1255
`Case 1:20-cv-01644-RGA Document 1-43 Filed 12/03/20 Page 1 of 4 PageID #: 1255
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`EXHIBIT 43
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`EXHIBIT 43
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`11/6/2020
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`VeriSeq NIPT Solution v2 FAQs
`Case 1:20-cv-01644-RGA Document 1-43 Filed 12/03/20 Page 2 of 4 PageID #: 1256
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`VeriSeq NIPT Solution v2
`Frequently Asked Questions
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`Support Center / Support Resources:
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`GENERAL
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`What types of samples does the solution use?
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`The solution uses maternal peripheral whole blood specimens collected in Streck BCT tubes from pregnant women of at least
`10 weeks gestation.
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`What equipment do I need to run the VeriSeq NIPT Solution v2?
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`The solution is performed on three primary pieces of equipment:
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`A VeriSeq NIPT MicroLab STAR from Hamilton.
`A next-generation sequencing instrument, such as a NextSeq 550Dx.
`A VeriSeq Onsite Server v2 or an existing VeriSeq Onsite Server upgraded to version 2.
`Additional lab equipment is necessary to complete a run. Refer to the VeriSeq NIPT Solution v2 Consumables and Equipment
`list (document # 1000000076886) for a full list of required equipment.
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`Does the genomewide screen cover the entire genome?
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`No. For genomewide screens, certain regions are excluded from analysis. A list of such blacklisted regions is available on the
`Illumina Support product page under Product Files. Genomic anomaly detection is only performed on non-excluded regions.
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`Can the solution be performed on women who conceived via assisted reproductive
`technology (ART), including use of a donor egg?
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`Yes, the solution uses a non-single nucleotide polymorphism (SNP) technology that does not rely on the similarities and
`differences between maternal and fetal cfDNA.
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`Can the solution detect polyploidies, such as triploidy?
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`The solution is not intended to detect polyploidies.
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`What is the difference between basic and genomewide screens in the VeriSeq NIPT Solution
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`https://support.illumina.com/clinical_support/clinical_kits/veriseq-nipt-solution-v2/faqs.html
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`11/6/2020
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`VeriSeq NIPT Solution v2 FAQs
`Case 1:20-cv-01644-RGA Document 1-43 Filed 12/03/20 Page 3 of 4 PageID #: 1257
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`v2?
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`The basic screen provides information on the trisomy status for chromosomes 21, 18, 13, X, and Y only. Genomewide screens
`provide partial deletions and duplications of 7 MB or more for all autosomes and aneuploidy status for all chromosomes.
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`In some countries, depending on regulations, fetal sex reporting and sex chromosome aneuploidy (SCA) reporting is not
`available.
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`LIBRARY PREP
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`Can the workflow be prepared manually?
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`No. The entire workflow is automated.
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`How many samples can I run?
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`You can conduct runs in 24, 48, or 96 sample batches.
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`Are index adapters included in the Sample Prep kit?
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`Yes. The Sample Prep kit includes a DNA Adapter Plate.
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`How many sample sequencing libraries can be multiplexed together in one pool?
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`You can use 24 or 48 sample pools.
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`Does the solution require pre- and post-PCR lab spaces?
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`There is no PCR step in the workflow. Therefore, no post-PCR lab space is required.
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`SOFTWARE
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`Can I run a sample with the basic screen analysis option and then later reanalyze the same
`sample with the genomewide analysis?
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`No. The sample needs to be reprocessed from the start for another analysis option.
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`Can samples on the same run have different screen types?
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`Yes.
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`https://support.illumina.com/clinical_support/clinical_kits/veriseq-nipt-solution-v2/faqs.html
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`VeriSeq NIPT Solution v2 FAQs
`Case 1:20-cv-01644-RGA Document 1-43 Filed 12/03/20 Page 4 of 4 PageID #: 1258
`What software does the solution require?
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`All software is provided with installation.
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`Can I download the VeriSeq NIPT Assay Software v2?
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`No. You must either purchase the VeriSeq Onsite Server v2 with the VeriSeq NIPT Assay Software v2 pre-installed or upgrade
`an existing VeriSeq Onsite Server to v2.
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`What chromosomes are reported by the VeriSeq NIPT Assay Software v2?
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`The basic screen provides information on the trisomy status for chromosomes 21, 18, 13, X, and Y only. Genomewide screens
`provide partial deletions and duplications of 7 MB or more for all autosomes and aneuploidy status for all chromosomes.
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`In some countries, depending on regulations, fetal sex reporting and sex chromosome aneuploidy reporting (SCA) is not
`available.
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`Can I incorporate results with my LIMS system?
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`Yes, all files are in MD5 format, which makes it easy to incorporate into any LIMS system. However, LIMS software should not
`be installed directly onto the PC for the VeriSeq NIPT MicroLab STAR.
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`Does the solution fail samples based on a fetal fraction cutoff?
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`No.
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`https://support.illumina.com/clinical_support/clinical_kits/veriseq-nipt-solution-v2/faqs.html
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