Company Announcements

In October, the Chinese FDA approved BGI’s BGISEQ-500 sequencer as a medical device.

China Money Network’s website reported on November 3 that regulators terminated Chinese sequencing company BGI’s application to list on the Chi-Next board of the Shenzhen Stock Exchange, citing incomplete documentation.

In December, BGI opened an office in Seattle Washington, forming BGI Groups USA, as part of the company’s North American expansion.

Horizon Discovery entered into OEM partnerships in November with three Chinese diagnostic kit developers to provide its HDx Reference Standards for novel NGS assay development, clinical trials and, eventually, for in-kit controls.

In November, Genalyte announced that it raised an additional $36 million in its latest financing round.

In December, Oxford Nanopore completed $126 million in fundraising through a private placement of ordinary shares, led by new investor GT Healthcare Capital Partners. This brings the total funds raised by the company to $444 million. The same month, Oxford University’s Wellcome Trust Centre and Genomics plc announced the first sequencing and analysis of multiple human genomes using Oxford Nanopore’s MinION sequencer.

GenDx, a company focused on development, production and sales of innovative assays and analysis software for transplantation medicine and companion diagnostics, announced in December a reseller agreement with Illumina for instruments, reagents and maintenance contracts for the field of HLA sequencing in a restricted number of countries, including Benelux, Italy, UK, Germany and Finland. The products will be delivered by GenDx’s local distributors.

In December, Rubicon Genomics signed a supply agreement with Agilent Technologies for its PicoPLEX WGA kits. They will be sold with Agilent’s GenetiSure Pre-Screen Kit for pre-implanation genetic screening.

Product Introductions 

In November, BGI launched the BGISEQ-50 NGS sequencer based on probe-anchor synthesis and DNA nanoballs technology. Including sample preparation, the sequencing process takes 18 hours. Sixteen NIPT tests can be completed per run. Initially launched in China, deliveries of the system will begin in early 2017.

Thermo Fisher Scientific introduced in November four additional NGS multi-biomarker targeted assays for cancer research: the Oncomine Immune Response Research Assay, the Oncomine BRCA Research Assay, the Oncomine Breast cfDNA Assay and the Oncomine Colon cfDNA assay. The Oncomine Immune Response Research Assay is a 395-gene panel, requiring 10 ng of FFPE RNA, designed to interrogate the tumor microenvironment and enable identification of predictive biomarkers for immunotherapy clinical research trials.

In November, QIAGEN and CosmosID released a metagenomics analysis plugin for the QIAGEN Microbial Genomics Pro Suite and CLC Genomics Workbench. The plugin supports shotgun metagenomics and microbiome profiling.

Oxford Gene Technology launched in December the SureSeq myPanel NGS Custom FH Panel for the study of familial hypercholesterolemia, featuring both SNV and CNV detection in a single NGS assay.

In December, Personal Genome Diagnostics introduced the CancerSELECT 125 test for pan-cancer tumor profiling, which incorporates assay technology and bioinformatics.

Sales/Orders of Note

BGI announced in November that it has received more than 500 orders for its BGISEQ-500 system since the end of 2015.

In November, Parabon Nanolabs announced the award of a two-year US Department of Defense contract to develop a software platform for forensic analysis of DNA evidence. The platform would allow bioinformatics data from any forensic science instrument to be analyzed via software plugins. The Institute of Advanced Genetics at the University of North Texas Health Science Center will assist in the project.