First wave of laboratories in Europe will conduct Harmony Prenatal Test in their own labs
San Jose, Calif. – June 11, 2015 – Roche (SIX: RO, ROG; OTCQX:RHHBY). Ariosa Diagnostics, Inc., a global leader in non-invasive prenatal testing (NIPT) technology and maker of the Harmony Prenatal Test, today announced that it has granted licenses to laboratories so that they can develop, validate, and conduct NIPT using the same technology that Ariosa has provided to over 500,000 women globally to date.
“Through these license agreements, Ariosa now enables laboratories to locally perform NIPT with the same technology we use in our CLIA laboratory in California to perform the Harmony Prenatal Test,” said Ken Song, CEO of Ariosa Diagnostics. “They represent a significant step in reaching our goal to offer the broadest access to the world’s leading and most validated NIPT to pregnant women worldwide.”
Features of the Harmony Prenatal Test technology include rapid turnaround time, fetal fraction measurement and reporting, scalability, and individualized patient risk score. Ariosa is pursuing CE-IVD certification for the Harmony Prenatal Test.
About the Harmony Test
The Harmony Prenatal Test is a blood test for pregnant women that can be used as early as 10 weeks into pregnancy. By evaluating cell-free DNA found in maternal blood, including accurate measurement of the fetal fraction of DNA, the test assesses the risk of Trisomy 21 (Down syndrome) in the fetus. It has been validated to CLIA requirements by a robust clinical data set and supported by clinical studies in more than 22,000 women of all ages and risk categories*. It is available in more than 90 countries and has been used to guide clinical care in over 500,000 pregnancies worldwide.
*Data have not been submitted to or evaluated by Federal regulatory agencies and the test is not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.
About Ariosa Diagnostics
Ariosa Diagnostics, Inc. is a leading global molecular diagnostics company committed to improving overall patient care by developing and delivering innovative, affordable, and widely-accessible testing services through their CLIA laboratory. Tests are fully validated to CLIA requirements by rigorous and comprehensive methodologies to ensure health care practitioners and patients can be confident in the test’s performance. Ariosa has developed leading-edge technologies to perform a directed analysis of cell-free DNA in blood. Ariosa is located in San Jose, California and was acquired by Roche in 2015. For more information, visit www.ariosadx.com
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
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