Roche Enters Additional Sectors with Acquisition of Ariosa

(San Jose, CA, USA), a leading molecular diagnostics testing service provider of a highly targeted and accurate noninvasive prenatal testing (NIPT) service through their CLIA laboratory using cell-free DNA (cfDNA) technology.

Ariosa’s proprietary “Harmony Prenatal Test” is a blood test 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. Prenatal screening for Down syndrome has become common practice in many countries; however, conventional screening tests return false-positive results up to 5% of the time, much higher than the 0.1% false-positives of the Harmony Prenatal Test. The 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. Data have not yet been submitted to or evaluated by regulatory agencies and the test is currently not for sale as an In Vitro Diagnostic (IVD) in the US or the EU.

With the acquisition, Roche enters both the NIPT and cfDNA testing services sectors. “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.

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