Hello,

We noticed you're browsing in private or incognito mode.

To continue reading this article, please exit incognito mode or log in.

Not an Insider? Subscribe now for unlimited access to online articles.

Susan Young Rojahn

A View from Susan Young Rojahn

FDA Gives Its First Okay to Next-Generation Sequencing Technology

High-throughput sequencing takes another step into the clinic with first regulatory approvals.

  • November 20, 2013

For the first time, U.S. regulators will allow high-throughput DNA sequencing technology to be marketed as a diagnostic test.

On Tuesday, the U.S. Food and Drug Administration announced that four products from Illumina, the leading manufacturer of DNA sequencing machines, could be marketed as diagnostic devices.

While other DNA sequencing-based diagnostics have received FDA approval (e.g. a test for matching organ transplants from Illumina competitor Life Technologies was approved earlier this year), this is the first time the agency has approved a so-called “next-generation” sequencing technology. That technology is cheaper and faster than earlier sequencing methods and has been critical in advancing medical DNA analysis.

The hope is that the advances in sequencing technology will enable doctors to examine a patient’s genome for clues about the origin of disease (see “Genomics Technology Races to Save Newborns”) or how a patient will respond to treatments (see “Foundation Medicine: Personalizing Cancer Drugs” and “Consumer Genetic Test Can Predict Your Drug Response”).

Two of the approvals were granted to an Illumina sequencing machine and its related reagents, which constitute the first FDA-regulated test system that allows laboratories to develop and validate sequencing of any part of a patient’s genome. This means that, using those products, any lab can test any sequence for any purpose, write National Institutes of Health head Francis Collins and FDA head Margaret Hamburg in an editorial published on Tuesday in the New England Journal of Medicine.

Their commentary hints that such lab-made tests could come under increased scrutiny: “putting in place an appropriate risk-based regulatory framework is now critical to ensure the validation and quality of tests.”

The need for such regulation 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 the poster child for the field, provide little help to doctors trying to find the best dose of blood thinners for their patients (see “Genetic Testing Falls Flat in Large Patient Drug Trials”).

The other two products approved by the FDA are genetic tests for identifying mutations that cause cystic fibrosis.

Want to go ad free? No ad blockers needed.

Become an Insider
Already an Insider? Log in.
More from Rewriting Life

Reprogramming our bodies to make us healthier.

Want more award-winning journalism? Subscribe to Insider Plus.
  • Insider Plus {! insider.prices.plus !}*

    {! insider.display.menuOptionsLabel !}

    Everything included in Insider Basic, plus the digital magazine, extensive archive, ad-free web experience, and discounts to partner offerings and MIT Technology Review events.

    See details+

    Print + Digital Magazine (6 bi-monthly issues)

    Unlimited online access including all articles, multimedia, and more

    The Download newsletter with top tech stories delivered daily to your inbox

    Technology Review PDF magazine archive, including articles, images, and covers dating back to 1899

    10% Discount to MIT Technology Review events and MIT Press

    Ad-free website experience

/3
You've read of three free articles this month. for unlimited online access. You've read of three free articles this month. for unlimited online access. This is your last free article this month. for unlimited online access. You've read all your free articles this month. for unlimited online access. You've read of three free articles this month. for more, or for unlimited online access. for two more free articles, or for unlimited online access.