Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the acquisition of Ariosa Diagnostics, Inc. (Ariosa), a privately-held company based in San Jose, California, USA. Ariosa is a molecular diagnostics testing service provider that provides a highly targeted and accurate non-invasive prenatal testing (NIPT) service through their CLIA laboratory using cell-free DNA (cfDNA) technology.
Ariosa’s proprietary HarmonyTM Prenatal Test is a blood test that is performed as early as 10 weeks into pregnancy. By evaluating fetal cfDNA found in maternal blood, the test is designed to assess the risk of Down syndrome and other genetic abnormalities. Specifically, the test assesses the risk of trisomies 13, 18, and 21, which are indicative of an extra chromosome in the fetus that can lead to severe genetic conditions.
The HarmonyTM Prenatal Test 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.*
There are more than 200 million pregnancies annually worldwide1 and prenatal screening for Down syndrome has become common practice, in many countries. Conventional screening tests return false positive results up to 5%2 of the time, compared to the HarmonyTM Prenatal Test which has a false positive result of less than 0.1%3.
“The acquisition of Ariosa is another example of Roche’s commitment to advanced molecular diagnostics,” said Roland Diggelmann, COO Roche Diagnostics Division. “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.”
“We are thrilled to join forces with Roche to continue in our commitment to bringing forward high quality and affordable genetic testing that positively impacts the medical care of patients around the world,” said Ken Song MD, CEO of Ariosa.
The closing of the transaction is expected to take place in December, 2014.
*Data have 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, Inc.
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. The company is headquartered in San Jose, California. For more information, visit http://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-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 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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1) WHO 2013 World Health Report
2) Screening for Fetal Chromosomal Abnormalities, Obstetrics & Gynecology, Vol.109, No.77, January 2007
3) Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. American Journal of Obstetrics and Gynecology, August 2012