Illumina Speaks About Plans for Clinical Sequencing

By Aaron Krol  

February 4, 2014 | Last November saw the passage of a milestone in clinical sequencing, when the MiSeqDx became the first next-generation sequencing (NGS) instrument approved by the FDA for use in clinical diagnostics. The approval marked a new stage in genetic medicine, giving care providers their first on-site access to technology that has been driving down costs and accelerating testing in academic labs for years. 

It was also a big win for Illumina, maker of the MiSeqDx, which will have the chance to plant a stake in the clinical markets before it’s joined by competitors like Life Technologies and QIAGEN. At the JP Morgan Healthcare Conference in San Francisco this January, Illumina CEO Jay Flatley told investors that the company had sold eight of the new MiSeqDx systems in the fourth quarter of 2013, citing this as part of a “continued evolution toward a fifty-fifty mix between academic and commercial customers” for a company that has traditionally leaned heavily on the research sector. 

Flatley also announced a commitment to scaling up its clinical offerings. “We’ve made a strategic decision to submit the HiSeq 2500 for FDA clearance,” he said, referring to Illumina’s centerpiece production instrument, which boasts over 60 times the maximum data output of the MiSeq. Clearance of the HiSeq 2500 would enable high-volume sequencing in a clinical setting, as opposed to the targeted, individual tests for which the MiSeq is best suited. 

Clinical Informatics News spoke to Greg Heath, Illumina’s Senior Vice President for In Vitro Diagnostics, about the company’s plans for clinical sequencing in 2014, and where he sees this technology moving in the future. 

Read the whole story at Clinical Informatics News.