FDA Gives Its First Okay to Next-Generation Sequencing Technology

For a initial time, U.S. regulators will concede high-throughput DNA sequencing record to be marketed as a evidence test.

On Tuesday, a U.S. Food and Drug Administration announced that 4 products from Illumina, a heading manufacturer of DNA sequencing machines, could be marketed as evidence devices.

While other DNA sequencing-based diagnostics have perceived FDA capitulation (e.g. a exam for relating organ transplants from Illumina aspirant Life Technologies was approved progressing this year), this is a initial time a group has authorized a supposed “next-generation” sequencing technology. That record is cheaper and faster than progressing sequencing methods and has been vicious in advancing medical DNA analysis.

The wish is that a advances in sequencing record will capacitate doctors to inspect a patient’s genome for clues about a start of illness (see “Genomics Technology Races to Save Newborns”) or how a studious will respond to treatments (see “Foundation Medicine: Personalizing Cancer Drugs” and “Consumer Genetic Test Can Predict Your Drug Response”).

Two of a approvals were postulated to an Illumina sequencing appurtenance and a associated reagents, that consecrate a first FDA-regulated exam complement that allows laboratories to rise and countenance sequencing of any partial of a patient’s genome. This means that, regulating those products, any lab can exam any method for any purpose, write National Institutes of Health conduct Francis Collins and FDA conduct Margaret Hamburg in an editorial published on Tuesday in a New England Journal of Medicine.

Their explanation hints that such lab-made tests could come underneath increasing scrutiny: “putting in place an suitable risk-based regulatory horizon is now vicious to safeguard a validation and peculiarity of tests.”

The need for such law is underscored by a set of reports also published in NEJM on Tuesday that showed that genetic tests for blood-thinner response, seen by many as a print child for a field, yield small assistance to doctors perplexing to find a best sip of blood thinners for their patients (see “Genetic Testing Falls Flat in Large Patient Drug Trials”).

The other dual products authorized by a FDA are genetic tests for identifying mutations that means cystic fibrosis.