In launching this system, Illumina has paved the way for future FDA-cleared systems, both from Illumina and its competitors. As the first NGS system cleared by the FDA, the MiSeqDx has become the “platform of reference” against which future platforms will be compared. These future platforms will still have to go through clinical trials, but the hurdle will be a bit easier as they just have to show “substantial equivalence” to the MiSeqDx.
Based on the success they’ve had so far, Illumina has announced that they’ll also submit their high-throughput platform, the HiSeq 2500, for FDA clearance. Following a similar strategy, they will release it with a specific assay (in this case it is likely to be based on their verifi® prenatal test) along with a universal kit.
Not to be outdone, Life Technologies (now part of Thermo Fisher Scientific) has announced that it will be submitting its Ion Torrent PGM platform for FDA clearance in the fall of 2014. This platform has already proved popular with clinical researchers due to its speed; a rapid turnaround time can be critical when dealing with patient samples. One area that the Ion Torrent platforms have lagged is that of ease of use due to their reliance on emulsion PCR, a tricky and time-consuming process. In an effort to address this issue, Life Technologies has launched the IonChef, an automated system that handles both emulsion PCR and chip loading.
Because NGS for the research market is dominated by Illumina, and also by Thermo Fisher Scientific to a smaller extent, developers of new platforms are focusing primarily on clinical sequencing, hoping to get a toe-hold in what is projected to be a large and fast-growing market.
Qiagen has plans to launch its new system, the GeneReader, later this year. While it uses a sequencing chemistry similar to that of Illumina, it will cater to the clinical user by using a larger number of small output flow cells, reducing or even eliminating the need to pool samples, which could lead to a quicker turnaround time and less cross-contamination risk. Also, the GeneReader will be integrated into a comprehensive workflow from Qiagen, covering sample prep all the way through data analysis.
Bio-Rad Laboratories recently entered the NGS market through its acquisition of GnuBIO. The GnuBIO targeted sequencing platform, which is currently in beta testing, uses picoinjector technology to form droplets in which individual sequencing-by-hybridization reactions take place. In addition to reducing reagent volumes (which keeps the price down), the microfluidic droplet system allows the user to generate arbitrary amounts of data that are tailored to their particular needs rather than generating a set amount of data for each run. This flexibility should fit well with the clinical workflow.