Sequencing
Company Announcements
In November, Agilent Technologies signed a memorandum of understanding (MOU) with GI Innovation (GII), a Korean clinical-stage biopharmaceutical company. The MOU establishes a framework in which the two companies will enter into a strategic partnership to explore potential genomic biomarkers of the tumor microenvironment in an early-phase trial of the investigational compound GI-101. This is Agilent's first partnership of this kind in Korea. The Agilent NGS panel tumor profiling assay that will be used enables genomic profiling of more than 500 cancer-related genes in a single assay with measurement of tumor mutational burden (TMB) including microsatellite instability-high (MSI-H), as well as variants characterization in tumor suppressor genes and genes involved in homologous recombinant repair (HRR), important emerging biomarkers in immuno-oncology.
The Access to Comprehensive Genomic Profiling Coalition (ACGP) announced that seven diagnostics and lab service providers have joined: Exact Sciences, Foundation Medicine, Illumina, LabCorp, QIAGEN, Roche Diagnostics and Thermo Fisher Scientific. The goal of the organization is to collectively advocate for appropriate broad US health insurance coverage of comprehensive genomic profiling for patients living with advanced cancer.
In November, clinical genomics company PierianDx and executive search firm Bench International announced the appointment of Mark McDonough as CEO and a Board member. He most recently served as CEO and board member for Immunis.AI. He succeeds Chairman and Interim CEO Joe Boorady, who remains as Chairman.
PerianDx announced in December an expanded partnership with Illumina to enable PierianDx genomic reporting solutions for use with AmpliSeq for Illumina Focus Panel, AmpliSeq for Illumina Myeloid Panel and the TruSight Hereditary Cancer Panel.
In December, Illumina announced that its NextSeq 550Dx NGS System received approval from China's National Medical Products Administration (NMPA) for genetic testing and diagnosis. The NextSeq 550Dx is Illumina's second clinical-grade sequencer to receive NMPA regulatory approval, following the 2018 approval of the MiSeq Dx. The NextSeq 550Dx has been cleared for IVDs in more than 40 countries.
In December, Illumina announced that Australia's Victorian Government collaborated with the University of Melbourne and Illumina to secure a $60 million investment for the Illumina–University of Melbourne Genomics Hub. The Hub combines Illumina's industry expertise with the support of the University of Melbourne's research and student body. According to Illumina, it is the first hub of its kind.
In December, Weill Cornell Medicine, NewYork-Presbyterian Hospital and Illumina announced a collaboration to sequence the complete human genomes of thousands of consenting patients in order to identify genetic alterations driving disease and potentially reveal previously unidentified therapies for treatment. The initiative, which also includes a collaboration between Weill Cornell Medicine, NewYork-Presbyterian Hospital and the New York Genome Center (NYGC), aims to evaluate the diagnostic potential of whole genome sequencing at scale. Under the initiative, which originates from Weill Cornell Medicine's Englander Institute for Precision Medicine, doctors at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center will offer qualifying patients the option to have their genomes sequenced as part of their diagnostic workups.
Illumina and Harvard Pilgrim Health Care announced in December a risk sharing agreement to make whole genome sequencing (WGS) available to certain Harvard Pilgrim members, effective January 1, 2021. The program will leverage WGS to support faster diagnoses of genetic diseases in children. Through this agreement, Harvard Pilgrim and Illumina will work together to evaluate how insurance coverage of WGS impacts patient care and healthcare costs. During the term of the agreement, Harvard Pilgrim will cover WGS through their network of lab providers for pediatric patients meeting specific criteria. Illumina and Harvard Pilgrim will share the risk on genetic testing costs.
TwinStrand Biosciences announced in November it entered into agreement to sublicense two foundational patent families to molecular information company Foundation Medicine and its affiliates relating to TwinStrand Duplex Sequencing error-correction technology. Duplex Sequencing increases the accuracy of NGS as much as 10,000 times, according to the company, allowing the detection of ultra-low frequency mutations.
Omniome, a developer of a novel DNA sequencing platform, appointed Robert Wicke as CEO in November. He served most previously as CEO of Halo Labs.
Third quarter revenues for HTG Molecular Diagnostics, a life science company whose mission is to advance precision medicine fell 67.1% to $1.8 million (see Bottom Line). Product and product-related services sales declined 60.5% to $1.7 million, while Collaborative development services revenue was down 93.0% to $0.76 million. The company ended the quarter with $30.5 million in cash, cash equivalents and short-term available-for-sale securities.
In November, HTG Molecular Diagnostics announced that as a result of its 1-for-15 reverse stock split, its common stock will begin trading on a split-adjusted basis on the Nasdaq effective November 23. Holders received a cash payment in lieu of fractional shares.
According to a November report on Nordic9, Single Technologies, developer of the Theta 3D sequencing platform, raised $6.1 million, adding to the $3 million previously raised. The platform utilizes confocal scanning and nanofluidic technology to combine NGS and spatial genomics.
OHMX.bio, a provider of omics solutions, and IVD testing firm Fujirebio Europe were awarded a €720,000 ($872,771) research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical IVD platform incorporating third-generation sequencing technologies. The IVD-seq project will initially focus on a cost efficient, accurate and portable IVD modular solution for highly polymorphic regions.
Product Introductions
Twist Bioscience, a company offering high-quality synthetic DNA using its silicon platform, announced in November the availability of the Twist Comprehensive Viral Research Panel, an NGS panel that includes more than 3,000 viral genomes. The panel is bundled with an analysis platform from OneCodex to enable an end-to-end workflow.
In November, Twist Bioscience and Biotia, a company that uses analytical software for infectious disease diagnostics, made available the RUO SARS-CoV-2 NGS Assay. The Assay is a highly sensitive nucleic acid hybridization capture–based assay used for detection, characterization and environmental monitoring of the SARS-CoV-2 virus. The test spans both diagnostic methods and vaccine research.
Oxford Nanopore released in November the MinKNOW App for iOS and Android devices. MinKNOW is the operating software that drives nanopore sequencing devices. It carries out several core tasks, including data acquisition, real-time analysis and feedback, local base calling and data streaming, while providing device control including selecting the run parameters, sample identification and tracking, and ensuring that the platform chemistry is performing correctly.
In December, Oxford Nanopore announced several new releases, including improvements in its PromethION flow cells that have enabled a new 10 Terabase sequencing record, modal single-read accuracy of 99.1% using a new sequencing chemistry currently in development, high-accuracy variant calling tools and automation options for nanopore sequencing experiments at any scale. In November, Oxford Nanopore started to ship PromethION flow cells that incorporate a number of iterative improvements in yields and consistency. These improvements have culminated in a 10 Tb internal run using all 48 Flow Cells, a 25% improvement over the previous record.
HTG Molecular Diagnostics launched in December an Early Access Program for its whole transcriptome panel using the HTG EdgeSeq technology. It features the ability to run small sample sizes without requiring RNA isolation and purification and the ability to successfully process low-quality samples.
Sales and Orders of Note
In December, Agilent Technologies announced its clinical informatics platform Alissa Interpret was adopted by the North West Genomic Laboratory Hub (NW GLH) based in Manchester and Liverpool, part of Manchester University NHS Foundation Trust, England. The NW GLH and its partners are responsible for delivering genomic testing across the whole of the North West. Alissa Interpret, which enables clinical genetics labs to standardize and automate variant triage, review, classification and reports on NGS data, becomes 1 of 2 platforms the NW GLH will use to analyze genomics data.
Pacific Biosciences of California, a provider of high-quality sequencing of genomes, transcriptomes and epigenomes, announced in December that the UK's Edinburgh Genomics, Oxford Genomics Center and University of Liverpool Centre for Genomic Research each added Sequel II or Sequel IIe Systems to expand the delivery of highly accurate long-read sequencing services.