Roche Acquires Molecular Diagnostics Firm
By Chuck Seegert, Ph.D.
Though financial details were not disclosed, Roche has declared its acquisition of Ariosa Diagnostics, a California-based molecular diagnostics firm. Ariosa provides highly targeted and non-invasive prenatal testing that assesses the risk of Down syndrome (DS) and other genetic abnormalities.
Prenatal genetic evaluation is often conducted by taking samples during amniocentesis, a procedure that can increase the risk of miscarriage or cause harm to the fetus. Alternative approaches using ultrasound also have their place, but can provide somewhat uncertain diagnoses.
A more accurate, non-invasive way of testing for genetic abnormalities is an unmet need that may now be filled by a new technology from Ariosa Diagnostics. The company has developed the Harmony Prenatal Test that can be administered to pregnant women as soon as 10 weeks into pregnancy, according to a recent release from Roche in The Wall Street Transcript (TWST).
The Harmony diagnostic test is used to assess the risk of genetic abnormalities like trisomies 13, 18, and 21, all of which cause Down syndrome, according to TWST. The test analyzes the fetal cell-free DNA (cfDNA) found in the mother’s blood.
A validation study that included more than 22,000 women was used to prove the accuracy and reliability of the test, which generates a false positive only 0.1 percent of the time, according to TWST. Conventional tests give false positive results approximately 5 percent of the time, which means that parents may believe that their child is affected by genetic issues when, in reality, they are not.
"The acquisition of Ariosa is another example of Roche's commitment to advanced molecular diagnostics," said Roland Diggelmann, COO of Roche’s Diagnostics Division, according to TWST. "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."
Roche claims to be a leader in research-focused healthcare that leverages its strengths in pharmaceuticals and diagnostics. In addition to this purchase, Roche also recently acquired another U.S. biotech company called InterMune for $8.3 billion in cash, according to a recent Reuters story.
Other notable players are making moves to enter the genetic testing market as well. For example, a Google-backed company called 23andMe recently announced its efforts to gain regulatory approval for genetic health testing kits that would be sold to consumers.