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.

Get stories like this before anyone else with First Look.

Subscribe today
Already a Premium subscriber? Log in.

Uh oh–you've read all of your free articles for this month.

Insider Premium
$179.95/yr US PRICE

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 ad-free web experience, select discounts to partner offerings and MIT Technology Review events

    See details+

    What's Included

    Bimonthly home delivery and unlimited 24/7 access to MIT Technology Review’s website.

    The Download. Our daily newsletter of what's important in technology and innovation.

    Access to the Magazine archive. Over 24,000 articles going back to 1899 at your fingertips.

    Special Discounts to select partner offerings

    Discount to MIT Technology Review events

    Ad-free web experience

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