Roche 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 Harmony 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 Harmony 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 per cent2 of the time, compared to the Harmony Prenatal Test which has a false positive result of less than 0.1 per cent.
“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 personalised 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, chief executive officer, 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.