Non-invasive prenatal test assessing Down syndrome risk expands international reach
SAN JOSE, California, Oct. 13, 2015 /PRNewswire/ -- Roche (SIX:RO) (SIX:ROG) (OTCQX:RHHBY) and Ariosa Diagnostics, Inc., a global leader in non-invasive prenatal testing (NIPT) technology1 and maker of the Harmony™ Prenatal Test, in conjunction with Australian company Sonic Healthcare, today announced that Sonic Healthcare has been granted a license to perform the Harmony Prenatal Test in its Australian and United Kingdom labs. Under the license, Sonic Healthcare will provide the Harmony Prenatal Test and cell-free DNA System, developed at Ariosa's California laboratory, through Sonic Genetics in Australia and Sonic's UK counterpart, The Doctors Laboratory (TDL).
The new partnership improves access to the Harmony Prenatal Test for obstetricians and general practitioners caring for pregnant women across Australia and the UK, via extensive networks of collection centres.
"Non-invasive prenatal testing is critically important for the pregnant woman and technically demanding for the laboratory. Sonic Healthcare is committed to providing doctors and their patients with the best available genetic tests. We have selected the Harmony Prenatal Test as our in-house NIPT test in Australia and the UK because it has an enviable track record of quality, reliability and robustness, having been performed for hundreds of thousands of women globally," said Graeme Suthers, Director of Genetics at Sonic Healthcare (Australia).
Features of the Harmony Prenatal Test technology include rapid turnaround time, fetal fraction measurement and reporting, scalability, and individualized patient risk score. Developed and distributed by Ariosa, the Harmony Prenatal Test is recognized worldwide as rigorously tested and validated in published prospective clinical studies.2 Ariosa's proprietary FORTE™ software has received the CE mark (Conformité Européenne).
"Our partnership with Sonic Healthcare in Australia and the UK is one of our many efforts to make the most validated prenatal test available in Asia-Pacific, Europe and across the globe," said Ariosa Chief Operating Officer Dave Mullarkey. "Australia and the UK now have access to the same technology we use in our CLIA (Clinical Laboratory Improvement Amendments) laboratory in California to produce the Harmony Test, which gives pregnant women, no matter their age or risk, highly accurate results2."
About the Harmony Test
The Harmony Prenatal Test is a blood test for pregnant women that can be used as early as 10 weeks in 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.3 It is available in more than 100 countries and territories and has been used to guide clinical care in more than 500,000 pregnancies worldwide.
1Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing. Ariosa Diagnostics is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this test service has not been cleared or approved by the US FDA.
2 Norton et al., New England Journal of Medicine, 2015 Apr 23;372(17):1589-97 (Both under 35 and over 35 age groups, studies have included women ages 18-48.)
3 Data has not been submitted to or evaluated by 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 its CLIA laboratory. Tests are fully validated to CLIA requirements by rigorous and comprehensive methodologies to ensure healthcare 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-nine 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 roche.com.
About Sonic Healthcare
Sonic Healthcare is an international healthcare company providing laboratory and radiology services to medical practitioners, hospitals, community health services and their collective patients. Sonic Healthcare additionally operates Australia's largest network of primary care medical centres—Independent Practitioner Network (IPN)—as well as other healthcare businesses. Sonic Healthcare is structured as a decentralised federation of medically-led practices. Headquartered in Sydney, Australia, the company employs 30,000 people in Australia, New Zealand, the United Kingdom, Germany, Switzerland, Belgium, Ireland and the US.
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SOURCE Ariosa Diagnostics, Inc.