• Delivers Illumina's flagship oncology products on its most powerful sequencers to enable comprehensive genomic profiling at greater scale and at lower overall costs for customers

SAN DIEGO, Aug. 5, 2024 /PRNewswire/ -- Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced it has expanded its oncology menu for NovaSeq™ X Series customers. The company began offering the newly verified high-throughput version of TruSight™ Oncology 500 (TSO 500 HT), and the latest version of its distributed liquid biopsy research assay, TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2), in recent months. These assays enable labs to confidently expand oncology testing research of tissue and liquid biopsy samples, with new transformative sequencing economics, faster sequencing run times, and broader batch sizes on the NovaSeq X Series for the first time.

"We are excited to deliver customers our flagship oncology assays, now fully tested and supported on the NovaSeq X," said Everett Cunningham, chief commercial officer of Illumina. "Empowering labs to scale distributed comprehensive genomic profiling serves to help advance the use of CGP in clinical oncology research and drive precision oncology forward."

Comprehensive genomic profiling (CGP) assesses hundreds of genes across all variant classes, and immuno-oncology biomarkers, in a single assay from one sample to enable therapy selection research. CGP is increasingly included in recommended professional guidelines in oncology.

TSO 500 HT on the NovaSeq X Series offers increased throughput with impactful sequencing economic improvements, as compared to the NovaSeq 6000 System. Illumina announced today that it will expand TSO 500 HT to the company's benchtop NextSeq 1000 and NextSeq 2000 Systems later this quarter.

TSO 500 ctDNA v2 on the NovaSeq X Series enables a faster, more sensitive, and streamlined liquid biopsy CGP workflow from minimally invasive blood samples for solid tumor therapy selection research, now in a fully supported and verified workflow.

Laura Knight, global VP of Genomic Services at Almac Diagnostic Services, said: "As a leader in next-generation sequencing diagnostics and research, Almac is delighted that Illumina TSO 500 ctDNAv2 is now being made available on the NovaSeq X Plus platform to enable comprehensive genomic profiling. The NovaSeq X Plus compatibility takes molecular analysis of blood-based biomarkers to new levels."

TSO 500 ctDNA v2 offers improvements including transformative sequencing economics; faster sequencing run times by about 40%, resulting in a three-day total assay turnaround time; and more sustainable logistics, with ambient temperature shipping for consumables.

"With increased throughput, faster turnaround time, and optimized reagent economics, Almac can now accelerate oncology research and diagnostic development," Knight added. "We believe that the TSO500 ctDNA v2 assay, combined with the power of NovaSeq X Plus, represents a transformative advancement in precision medicine."

About the TruSight Oncology 500 portfolio

The TSO 500 portfolio is a research-use-only pan-cancer portfolio that enables comprehensive genomic profiling from either tissue or liquid (blood) biopsies. Designed to identify known and emerging tumor biomarkers across 523 genes, the TSO 500 portfolio utilizes both DNA and RNA (DNA only for liquid biopsy analysis) from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants (single nucleotide variants, indels), fusions, splice variants, and copy number variants. In addition, it assesses key genomic signatures, such as tumor mutational burden (TMB), microsatellite instability (MSI), and Homologous recombination deficiency (HRD).

Use of forward-looking statements

This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services; (ii) customer uptake of, and satisfaction with, new products and services; and (iii) legislative, regulatory and economic developments, together with other factors 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 undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a 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 illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube. 

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