In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|December 2, 2014
Roche Adds Non-Invasive Prenatal Testing to Pipeline with Ariosa Acquisition
Author(s)BioPharm International Editors
Roche announced the acquisition of Ariosa Diagnostics, a molecular diagnostics testing service provider and maker of the prenatal blood test, Harmony.
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Roche announced on Dec. 2, 2014 the acquisition of Ariosa Diagnostics, a US-based molecular diagnostics company providing highly-targeted, non-invasive prenatal testing (NIPT) using cell-free DNA (cfDNA) technology. The transaction is expected to close in December 2014.
Ariosa’s blood test, Harmony Prenatal Test, evaluates fetal cfDNA found in maternal blood and is designed to assess the risk of genetic abnormalities, including Down syndrome. The test specifically analyzes trisomies 13, 18, and 21 and has a false-positive result of less than 0.1%.
“Circulating cfDNA has the promise of providing early diagnostic information through a simple blood test in many important segments including pregnancy, cancer, and transplantation, aligning with our strategy in personalized healthcare and commitment to setting new standards of care,” said Roland Diggelmann, COO Roche Diagnostics Division, in a press release.
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