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SAN DIEGO—Illumina Inc. wants to give more people on the bench access to next-generation sequencing (NGS), and part of that effort involved building the NextSeq 2000 Sequencing System and NextSeq 1000 Sequencing System “from the ground up” and pushing the TruSight Software suite to help accelerate adoption of genomics—all to demonstrate “its commitment to making genomics more accessible for the potential benefit of patients” and “to unlocking the power of the genome.”
The NextSeq 2000 Sequencing System, the latest NGS system from Illumina, reportedly offers innovative design features, advanced chemistry, simplified bioinformatics and an intuitive workflow that enable the widest range of applications on a benchtop sequencing system. The system is available this quarter, while the NextSeq 1000 Sequencing System is expected to begin shipping in the fourth quarter of 2020.
“Almost everything is new,” said Francis deSouza, CEO of Illumina. The company noted in a statement that they incorporate more than 75 innovations, including two brand-new technologies: so-called super resolution optics and blue/green SBS chemistry, which will together enable a substantial increase in density and throughput as well as a reduction in operating costs. Further elaborating on this at a recent JP Morgan meeting, deSouza noted that the super-resolution optics are capable of “breaking the diffraction limit” and are reportedly achieving what has been achieved on no other commercial sequencer. Meanwhile, the blue/green SBS chemistry allows a greater separation of signals, so they can be closer together, the company adds.
This total package could promise a more than 30-fold increase in data density, according to deSouza.
The platforms are also the first to incorporate Dragen processing on board, featuring both local and cloud-based options for run setup, management and analysis. The two new sequencers are expected to find ready homes in areas like single-cell RNA-seq, circulating tumor DNA analysis, and a variety of oncology panels.
The company’s TruSight Software Suite v1.0, meanwhile, is said to deliver “ready-made infrastructure to adopt, ramp and realize the full potential of genome sequencing in rare and undiagnosed genetic disease. TruSight Software enables sample-to-report for genetic disease making it easier to access the valuable insights enabled by sequencing with comprehensive variant class analysis for greatest diagnostic yield.”
The NextSeq 2000 will have a maximum sequencing data output of 300 Gb and a U.S. list price of $335,000, while the NextSeq 1000 will have a maximum output of 120 Gb and a U.S. list price of $210,000.
“We are proud to continue our tradition of driving down the cost of sequencing without compromising accuracy,” commented Omead Ostadan, senior vice president of marketing and products at Illumina. “NextSeq 1000 and 2000 are designed to enable core labs, small to medium research labs and clinical facilities to access high-intensity sequencing applications using our industry-leading SBS technology.”
Looking forward, deSouza expects both new-to-sequencing customers and existing NextSeq customers to transition to the new platforms.
In other news shared at the same time as the new NGS systems, Illumina and Roche announced a 15-year, non-exclusive collaboration agreement to broaden the adoption of distributable NGS testing in oncology. As the understanding of genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring.
This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of this agreement, Illumina will grant Roche rights to develop and distribute in-vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems, including the forthcoming NovaSeqDx. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay, TruSight Oncology 500 (TSO 500), with new companion diagnostic (CDx) claims. The financial terms of the deal were not disclosed.
Under the IVD terms of the agreement, Roche will develop, manufacture and commercialize AVENIO IVD tests for both tissue and blood for use on Illumina’s NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Illumina and Roche will develop tests and pursue CDx claims on TSO 500 for both existing and pipeline oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process, and will continue to manufacture, supply and commercialize TSO 500. Roche will support the development of the claims and regulatory filings.
“We are excited Roche has selected Illumina’s sequencers as their platform of choice to accelerate the adoption and broaden the reach of oncology-based, distributable IVD tests into clinical care,” said deSouza. “This partnership complements and strengthens our strategy to establish TSO 500 as a comprehensive NGS panel for cancer therapies by expanding the supported set of CDx claims on this universal panel. Building on the momentum of other recently established diagnostic and pharmaceutical partnerships, together we aim to advance critical access to NGS testing to improve patient outcomes.”
Illumina also announced the development of a regulatory-cleared version of the high-throughput NovaSeq system to address growing demand for a Dx platform to support deeper sequencing at higher throughput. NovaSeqDx extends the company’s portfolio of Dx cleared systems and, ahead of commercial availability targeted for 2022, will be available to IVD partners, including Roche, for content development.
“At Illumina, we are focused on three key areas to scale the reach and impact of genomics—enabling breakthrough genomics research, accelerating the clinical adoption of genomics and delivering fundamentally enabling technology innovations,” said deSouza. “The NextSeq 1000 and 2000 Sequencing Systems, TruSight Software and our partnership with Roche, will accelerate the adoption of research and clinical sequencing for the benefit of humanity.”