Illumina Applauds FDA’s Issuance of Draft Guidances

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to the oversight of next generation sequencing (NGS) diagnostic tests, as represented by FDA’s release of two new draft guidance documents.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The two FDA draft guidance documents, Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases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.