Ariosa receives CE mark for its FORTE Software to support Harmony™ Prenatal Test
SAN JOSE, California, June 11, 2015 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:RHHBY). Ariosa Diagnostics, Inc., a global leader in non-invasive prenatal testing (NIPT), today announced its proprietary FORTE™ software has received the CE mark (Conformite Europeenne). As one of Europe's major assurances of quality, the CE marking is a significant achievement toward the continued expansion of the Harmony Prenatal Test in Europe and globally.
"FORTE software is a cornerstone of the Harmony Prenatal Test, which has been one of the most trusted brands in NIPT among patients and OB/GYNs to determine the risk of trisomies in more than 500,000 patients in the world," said Ariosa Chief Operating Officer Dave Mullarkey. "Achieving this regulatory milestone validates our efforts and allows Ariosa to partner with labs throughout Europe and license the FORTE software required for technology transfers."
The FORTE software is used to enable analysis of cell-free DNA (cfDNA) isolated from plasma from a pregnant woman, in order to assess the risk of fetal chromosome 21, 18, and 13 trisomy, the risk of fetal chromosome X and Y aneuploidy, and fetal sex. As a result, the FORTE software, in conjunction with other clinical indicators and risk factors, can provide a more accurate assessment of fetal chromosome conditions than other statistical methods.1 The FORTE software will reside on a server at licensed labs to allow processing of patient data in the country of testing.
Receipt of the CE mark for the FORTE software is supportive of the quality of the design and development of the FORTE software.
1 Ashoor G et al., Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.
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
About Roche
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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