NEW YORK (GenomeWeb) – Canon USA has established a new biosciences subsidiary that will be charged with bringing to market various life science innovations, including a research-use-only molecular testing platform that is set to launch later this year, according to a company official.
The new subsidiary, Canon BioMedical, will be based at Canon USA's headquarters in Melville, NY, and will serve as worldwide headquarters for Canon's biomedical business. Under the leadership of President and CEO Akiko Tanaka, the new subsidiary will manage many of the projects that were previously overseen by Canon US Life Sciences in Rockville, Md.
These projects include, most notably, the development of the MDx platform, which is based on ultra-fast serial PCR and high-resolution melt (HRM) analysis, as well as a recently announced diagnostic collaboration with T2 Biosystems, Brian McNally, a senior marketing specialist with Canon, told GenomeWeb in a recent interview.
Canon BioMedical's MDx platform has been nearly a decade in the making, beginning in the mid-2000s when Canon licensed microfluidics intellectual property from Caliper Life Sciences (now part of PerkinElmer) with the goal of combining that tech with PCR, HRM, and various innovations from Canon imaging and printing products into a single genetic testing platform.
In 2011 company researchers demonstrated how its prototype system could run a rapid assay to accurately genotype 23 mutations related to cystic fibrosis, and a Canon scientist noted at the time that the company hoped to have a commercial product by the end of 2013.
That timeline was pushed back, however, as the company continued to tweak its platform and add new innovations, and in October of last year company scientists and collaborators from the Carl Wittwer lab at the University of Utah published a key proof-of-principle study in Clinical Chemistry demonstrating the capabilities of a beta version of the system.
That study used a four-SNP thrombophilia panel to demonstrate proof of principle but is just an example of what can be done on the platform, McNally told GenomeWeb on the sidelines of Cambridge Healthtech Institute's Molecular Medicine Tri-Conference in San Francisco last month.
"Generally we are going to try and pair a robust RUO assay menu with it … mostly focused on variant detection for inherited diseases, and … pharmacogenetics – classic SNPs, in the vein of warfarin testing [and blood-clotting factors]," McNally said. "We'll … show people different applications that they could work on, but it also is open to [developing] your own assay. That's one of the reasons we want to launch it in the RUO space — we want people to play with it and develop on it."
Also at Tri-Con, Hanyoup Kim, a senior scientist at Canon US Life Sciences, discussed several of the unique engineering features of the current beta platform during a presentation. Kim noted that most real-time PCR instruments on the market also feature HRM, but may require multiple pipetting steps. The Canon system, on the other hand, streamlines this workflow.
After a user inputs isolated genomic DNA onto an injection-molded plastic cartridge and places it in the system, on-board liquid handling facilitates "serial in-line PCR and HRM on a chip." The platform features high-speed temperature ramping — 50 °C per second for heating and 20 °C per second for cooling — which enables individual PCR reactions to be completed in about 12.5 minutes. Notably, U of Utah's Wittwer, who has been pushing the temporal boundaries of PCR to around 30 seconds per reaction, noted in 2013 that the Canon platform at that time was the closest of any existing instrument platform to being able to practically implement such speedy reactions.
The Canon system does not perform multiplexed PCR, per se, because it doesn't run all the reactions simultaneously; rather, it performs more of an automated, serial, multi-analyte analysis, McNally said.
"It resembles multiplexing, though, [because] the user doesn't have to do all this manipulation," he said. "The instrument is taking care of all that for you. Therefore, the end result feels a lot like a multiplex. You pipette in your sample once, and then you get all this data."
In the Clinical Chemistry study, the researchers demonstrated that the platform genotyped four SNPs in 100 samples each from two study sites with 100 percent accuracy. During his Tri-Con talk, Kim noted that the group has now accurately genotyped some 800 samples. The platform's microfluidics allow it to process eight samples at a time.
"One of the challenges of PCR-based multiplexing is that there is a practical limit to the number of tests you can run," McNally noted. "Usually four or five colors, maybe six, [and if] you add a trick or two maybe you get it to 12, but then you have to optimize the chemistry to go with it. And there are all sorts of issues in terms of interference, competition in the reaction, and things like that."
The Canon platform is not limited by such issues "because the reactions are separated enough that essentially you can just plex and play," McNally said.
Even though the platform is still in what McNally called a "beta" stage, he said that the company plans to commercially launch the system by the end of this year.
One of the goals of the RUO launch, McNally noted, is for Canon to gather feedback regarding the platform's potential clinical utility. If the company finds there is a market for clinical testing on the platform, it is prepared to begin moving it through the regulatory clearance process.
McNally cited another presentation at Tri-Con in which the developer of a US Food and Drug Administration-cleared multiplexed PCR system noted that it's prudent for any companies with similar aspirations to open a dialogue with the FDA "as soon as possible and as often as possible."
"We've taken that type of advice very seriously, and have brought in a lot of quality experts, a lot of whom have FDA experience so we can essentially prepare for our submission, if we choose to do that," McNally said.