Sequenom CMM’s MaterniT21 PLUS Test also Accurate for Trisomy 18 & 13

Sequenom, Inc. has announced that its wholly-owned subsidiary, the Sequenom Center for Molecular Medicine (Sequenom CMM), has expanded the application of its recently launched laboratory-developed test (LDT). The test has also been rebranded under the name MaterniT21 PLUS, which now includes the detection of trisomies 18 and 13, in addition to trisomy 21.

The MaterniT21 PLUS test provides direct assessment of fetal chromosomal status by analyzing cell-free DNA in a maternal blood sample. The test is intended for use in pregnant women at increased risk for fetal aneuploidy and can be used as early as 10 weeks gestation. Results of the MaterniT21 PLUS test are delivered directly to ordering physicians and will include the presence of any of the three trisomies for their high-risk patients.

The clinical validation results describing the test's ability to accurately detect trisomy 21 were published in the journal Genetics in Medicine in October 2011, and a new analysis on the detection of trisomy 18 and 13 has been published online, and will be available in the journal's March 2012 issue. The published research to date demonstrates high accuracy of the test, which detected nearly all cases of fetal trisomy 21, 18 and 13 in the clinical study with a very low false positive rate.

"The technology and data behind the MaterniT21 PLUS test have been studied extensively and have demonstrated high accuracy in detecting T21, T18 and T13 in women who are at an increased risk of carrying a child with one of these chromosomal anomalies," said Harry F. Hixson, Jr., Ph.D., Chairman and CEO, Sequenom, Inc. "The MaterniT21 PLUS was rebranded to reflect the additional applications of the technology that make it a valuable DNA-based tool to support prenatal specialists in making informed decisions about their patients' care."