Illumina Applauds FDA’s Issuance of Draft Guidances to Advance Precision Medicine Using Next Generation Sequencing
July 07 2016 - 9:20AM
Business Wire
Illumina, Inc. (NASDAQ: ILMN) today 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FDA’s release of two new draft guidance documents.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The two FDA draft guidance documents, Use of Standards in FDA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.
About Illumina
Illumina is improving human health by unlocking the power of the
genome. Our focus on innovation has established us as the global
leader in DNA sequencing and array-based technologies, serving
customers in the research, clinical and applied markets. Our
products are used for applications in the life sciences, oncology,
reproductive health, agriculture and other emerging segments. To
learn more, visit www.illumina.com and follow @illumina.
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Illumina, Inc.Investors:Rebecca Chambers,
858-255-5243IR@illumina.comorMedia:Eric Endicott,
858-882-6822PR@illumina.com
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