FDA OKs 4 Illumina next-generation sequencing devices

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

Suggested Articles

BD will begin working with Babson Diagnostics to help bring its lab-quality device for collecting blood from capillaries into retail pharmacies.

The former CEO of the molecular testing company Foundation Medicine, Troy Cox, has been named chairman of the Swiss big data firm Sophia Genetics.

Researchers at MIT used a machine-learning algorithm to uncover the potent antibiotic properties hiding within an old small-molecule candidate.