Illumina ($ILMN) gained the FDA's OK for a number of next-generation gene sequencing diagnostic devices--four in all--marking another advance for technology increasingly eyed for everyday use in regular medical care.
The FDA itself rather than the San Diego gene sequencer made the initial announcement, a move the regulatory agency typically reserves for diagnostics or devices it sees as game-changers.
Two of the four products are cleared to screen for DNA changes that can point to cystic fibrosis. They are the MiSeqDx Cystic Fibrosis 139-Variant Assay and the Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The two other products--the company's MiSeqDx instrument platform and its Universal Kit reagents--are designed to help labs pursue and validate sequencing for a patient's genome. The reagents help isolate and make copies of relevant genes taken from a blood sample, and the instrument platform handles the actual analysis. The FDA cleared both by way of its de novo classification process.
Next-generation gene sequencing is increasingly coveted for everyday medical care, and the industry is working hard to respond.
California's GenapSys recently gained a $37 million Series B financing designed to help advance and commercialize its next-generation sequencing technology for research, plus testing of genetic diseases, cancer and microbes. In October, investors gave $15 million in Series A financing to NextCODE Health in Massachusetts, a startup devoted to using gene sequencing technology to help doctors and geneticists quickly diagnose patients; it relies on intellectual property from the old deCODE Genetics. And then there's Enzymatics in Beverly, MA, which recently bought Colorado startup ArcherDx in a deal worth as much as $50 million so it could access its next-generation genomics diagnostic technology.
Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, noted in a statement made as part of the Illumina approval announcements that next-generation sequencing is rapidly advancing into everyday healthcare.
"Before [next-generation sequencing], sequencing genes associated with a particular disease was a long and costly process," he said. "Today, we have the capability to read and interpret large segments of DNA very quickly in a single test, and this information-rich technology is becoming more accessible for use by physicians in the care of their patients."
- here's the FDA release