We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement
Illumina Applauds FDA’s Issuance of Draft Guidances
News

Illumina Applauds FDA’s Issuance of Draft Guidances

Illumina Applauds FDA’s Issuance of Draft Guidances
News

Illumina Applauds FDA’s Issuance of Draft Guidances

Read time:
 

Want a FREE PDF version of This News Story?

Complete the form below and we will email you a PDF version of "Illumina Applauds FDA’s Issuance of Draft Guidances"

First Name*
Last Name*
Email Address*
Country*
Company Type*
Job Function*
Would you like to receive further email communication from Technology Networks?

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

Illumina, Inc. has announced that it supports the Food and Drug Administration (FDA) in their efforts to provide a flexible and streamlined approach to the oversight of next generation sequencing (NGS) diagnostic tests, as represented by FDA’s release of two new draft guidance documents. The FDA draft guidances are part of the larger Precision Medicine Initiative announced by President Obama in his 2015 State of the Union address.

“This is an important step forward,” said Francis deSouza, President and CEO of Illumina. “We support the proactive actions the FDA is taking to recognize the benefits of next generation sequencing and provide appropriately flexible and adaptive regulatory oversight of these tests, while accommodating the rapid evolution of NGS technologies.”

Next generation sequencing can examine millions of DNA variants at a time, reading a patient’s DNA to detect genomic variations that determine whether a person has or is at risk of disease and informing treatment decisions. Illumina will continue to partner with customers and work with FDA to collectively enable the promise of genetic medicine by driving the adoption of next generation sequencing.

The two FDA draft guidance documents, Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases and Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing Based In Vitro Diagnostics, were released July 6th.

Advertisement