Case 1:20-cv-01644-RGA Document 1-72 Filed 12/03/20 Page 1 of 4 PageID #: 2122
`Case 1:20-cv-01644-RGA Document 1-72 Filed 12/03/20 Page 1 of 4 PageID #: 2122
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`EXHIBIT 72
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`EXHIBIT 72
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`11/17/2020
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`Abstract 3114: Analytical validation of Illumina's TruSight Oncology 500 ctDNA assay | Cancer Research
`Case 1:20-cv-01644-RGA Document 1-72 Filed 12/03/20 Page 2 of 4 PageID #: 2123
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`Abstract 3114: Analytical validation of Illumina's TruSight Oncology 500
`ctDNA assay
`
`Kirsten C. Verhein, Gunjan Hariani, Stephanie B. Hastings, and Patrick Hurban
`DOI: 10.1158/1538-7445.AM2020-3114 Published August 2020
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`Proceedings: AACR Annual Meeting 2020; April 27-28, 2020 and June 22-24, 2020; Philadelphia, PA
`
`Abstract
`
`While tissue biopsies and imaging techniques remain the current standard of care, minimally invasive liquid biopsy tests are emerging as compelling
`complements in the clinical management of cancer patients. The ability to accurately detect low frequency somatic mutations, tumor mutational
`burden (TMB) and microsatellite instability (MSI) biomarkers from a single plasma sample using a broad-based NGS panel is of high value for
`biomarker discovery, detection and monitoring. Herein we report the results of our analytical validation of Illumina's TruSight Oncology 500
`(TSO500) ctDNA assay which employs a hybrid-capture approach for target enrichment of 523 clinically-relevant cancer genes with unique
`molecular indices (UMIs) to enable detection of low frequency variants, CNVs, DNA fusions, TMB and MSI analysis.
`
`To characterize performance of small variant detection (SNVs and indels) and TMB analysis using the TSO500 ctDNA assay, we utilized various
`contrived reference standards with >1,500 unique variants below 5% variant allele frequency (VAF) and over 50 uncharacterized diseased and 20
`healthy plasma samples. Cell-free DNA (cfDNA) isolates from healthy donors were used to evaluate the false positive (FP) rate as well as to
`evaluate potential impacts of blood collection tube (BCT) type on variant calling. For the tube type comparison, we procured 5 matched sets of
`healthy donor blood in both EDTA and Streck cfDNA BCTs. Where possible, unexpected somatic variants detected in healthy donor samples were
`orthogonally confirmed using droplet digital PCR (ddPCR). Additionally, to evaluate robustness of input on variant detection and TMB precision,
`cfDNA isolates from late stage cancer patients were tested at varying input amounts (10, 20, 30ng) in the TSO500 ctDNA assay.
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`Analytical sensitivity, specificity and positive predictive value (PPV) were evaluated using reference standards. We observed >99% sensitivity for
`detecting SNVs and >98% for indels at or above 0.5% VAF. Additionally, we observed very high specificity and PPV (>99%), with a false positive
`rate of < 2 FP per 1.3 Mb down to 0.2% VAF. Further support for high specificity was observed in healthy donor samples where 25/26 apparent false
`positive somatic variants (0.2-0.7% VAF) were confirmed using ddPCR. Robustness of input studies revealed comparable coverage depth and
`uniformity can be achieved with 20 - 30 ng of cfDNA. Precision of variant detection and TMB will be reported for a subset of the diseased plasma
`sample cohort. In conclusion, the TSO500 ctDNA assay enables robust detection of low frequency variants and other clinically relevant biomarkers
`in EDTA and Streck derived plasma samples with at least 20ng of cfDNA input.
`
`Citation Format: Kirsten C. Verhein, Gunjan Hariani, Stephanie B. Hastings, Patrick Hurban. Analytical validation of Illumina's TruSight Oncology
`500 ctDNA assay [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and
`Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 3114.
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`©2020 American Association for Cancer Research.
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`https://cancerres.aacrjournals.org/content/80/16_Supplement/3114
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`11/17/2020
`Abstract 3114: Analytical validation of Illumina's TruSight Oncology 500 ctDNA assay | Cancer Research
`Case 1:20-cv-01644-RGA Document 1-72 Filed 12/03/20 Page 3 of 4 PageID #: 2124
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`11/17/2020
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`Abstract 3114: Analytical validation of Illumina's TruSight Oncology 500 ctDNA assay | Cancer Research
`Case 1:20-cv-01644-RGA Document 1-72 Filed 12/03/20 Page 4 of 4 PageID #: 2125
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`NSCLC=non–small cell lung cancer;
`RET=rearranged during transfection.
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`Copyright © 2020 by the American Association for Cancer Research.
`Cancer Research Online ISSN: 1538-7445
`Cancer Research Print ISSN: 0008-5472
`Journal of Cancer Research ISSN: 0099-7013
`American Journal of Cancer ISSN: 0099-7374
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`DID YOU KNOW?
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`RET is an actionable
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`biomarker in metastatic
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`NSCLC.
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