This article was originally published May 12.
NEW YORK (GenomeWeb) − Bio-Rad Laboratories plans to commercialize GnuBio's droplet-based sequencing technology within two years, the company said last week. It also disclosed that it paid $40 million in cash for GnuBio when it acquired the firm last month, and could make up to $70 million in development and sales milestone payments over the next three years.
For several years, GnuBio has been developing a hybridization-based microdroplet sequencing technology, which uses a picoinjector method developed by co-founder David Weitz at Harvard University. Last year, the company started shipping its first instruments to beta customers and said it was expecting to commercialize the platform, which focuses on targeted sequencing of dozens of genes and offers an integrated workflow, by the summer or fall of 2014.
Bio-Rad said last month that it plans to commercialize GnuBio's technology for clinical diagnostics, initially in the areas of oncology, HLA testing, and infectious diseases, and to obtain regulatory clearance for the instrument and assays from the US Food and Drug Administration. The technology, it said, complements and expands its existing droplet digital PCR technology.
During a conference call to discuss Bio-Rad's first quarter earnings last week, Chief Financial Officer Christine Tsingos said that "it will likely take a few years to bring this product to market." Over the next few quarters, Bio-Rad "will be investing heavily to bring this exciting new technology to the diagnostic market," she said, approximately $5 million for R&D per quarter, which will be booked under its clinical diagnostics unit.
Asked about a timeline for commercialization, Brad Crutchfield, president of Bio-Rad's Life Science group, said that "there is a lot of work to do" on getting the integrated cartridge technology "bulletproof" as well as to clear regulatory hurdles, which he said is "certainly something we wish to do within two years."
In bringing a new sequencing platform to market for clinical applications, Bio-Rad will compete with several players. Qiagen, for example, is working on commercializing the GeneReader, which is based on technology it obtained through the acquisition of Intelligent Bio-Systems in 2012. Last week, Qiagen said it has postponed the launch of the system, which will be part of a workflow that is aimed at clinical laboratories, to 2015.
Also, Roche teamed up with Pacific Biosciences last year to develop a sequencing system and assays for clinical diagnostics, paying the firm $35 million in cash and up to another $40 million for development milestones, but it has not provided a commercialization timeline.
In the meantime, Illumina remains the only company with an FDA-cleared next-gen sequencer on the market, the MiSeq Dx, while Thermo Fisher's Ion Torrent plans to register the PGM with the FDA this fall.