Published October 18, 2011
Genetic analysis products maker Sequenom Inc , which had a troubled past related to mishandling of clinical data, launched a prenatal test for Down Syndrome that can eliminate the need for risky, invasive procedures.
Current invasive-prenatal tests to detect Down Syndrome require doctors to either extract a small amount of the fluid that surrounds the fetus or take a sample of the placenta.
These tests, which can be done when a woman is 10 to 12 weeks pregnant, increase the risk of miscarriage.
Sequenom's MaterniT21 test only needs the mother's blood to detect a chromosomal abnormality that causes Down Syndrome and the test can also be used as early as the tenth week of pregnancy.
The company claimed the test was 99.1 percent accurate.
This compares with an 85-90 percent accuracy rate for other blood tests, used in conjunction with ultrasounds, after 11 weeks of pregnancy and the near-certain detection rates of the invasive procedures.
Sequenom's MaterniT21 test detects a genetic chromosomal anomaly known as Trisomy 21, the most common cause of Down Syndrome, the company said.
Privately held Verinata Health Inc poses the most competitive threat for Sequenom's test and is expected to launch a similar product in the first quarter 2012, analyst Zarak Khurshid of Wedbush Securities told Reuters.
Privately-held Gene Security Network is also currently testing its prenatal diagnostic test to detect chromosomal anomalies by analyzing fragments of fetal DNA.
Down Syndrome is a chromosomal disorder that affects infants, resulting in impaired cognitive ability and abnormal facial features.
In 2009, Sequenom faced a scandal related to mishandling of key clinical data with another Down Syndrome test that led to the removal of its top management, including the then CEO and research chief, followed by legal and regulatory probes.