Fabrice Vincent of LCHB introduced litigation involving a blood test being marketed as DNA testing to rule out an unborn fetus having Down Syndrome (trisomy 21). Contrary to its claims, the product tests the placenta rather than the fetus’ DNA , resulting in false negatives . Although parents – to be rely on the blood test results to rule out Down Syndrome rather than going through more invasive yet more reliable testing via amniocentesis, Ariosa Diagnostic Inc’s test is unreliable and does not provide parents what it claims to give them; certainty that Down Syndrome is ruled out.
It is estimated that there are 600 false negative tests in the US each year meaning 600 births of children with Down Syndrome despite negative blood
testing. Millions of these tests are being carried out world wide.
It is estimated to cost $20 million to care for one person with Down Syndrome over a lifetime.
Ariosa Diagnostics Inc. is located in San Jose, California and was acquired by Roche in 2015. Regardless of where the patient’s blood it drawn, the
Specimen is shipped to and tested in Laboratory Testing of America in Silicone Valley, California.
Case lab will look into this product and the potential for litigation in other jurisdictions.
