The MaterniT® 21 PLUS laboratory-developed test can tell you if you are having a boy or a girl, and screens for both common and rare chromosomal abnormalities. The test screens for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), and many other conditions that can affect your baby’s health.
MaterniT 21 PLUS is a laboratory-developed test developed, validated and performed exclusively by Sequenom Laboratories. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although laboratory-developed tests to date have not been subject to US FDA regulation, certification of the laboratory is required under the Clinical Laboratory Improvement Amendments (CLIA) to ensure the quality and validity of test results. Sequenom Laboratories is CAP accredited and certified under CLIA as qualified to perform high complexity clinical laboratory testing. While the results of the MaterniT 21 PLUS test are highly accurate, discordant results may occur. This test is a screening test and not diagnostic; it does not replace the accuracy and precision of prenatal diagnosis with CVS or amniocentesis. A patient with a positive test result should be referred for genetic counseling and offered invasive prenatal diagnosis for confirmation of test results. A negative test result does not ensure an unaffected pregnancy. Testing could lead to the potential discovery of both fetal and maternal genomic abnormalities that could have major, minor, or no, clinical significance. The ability to report results may be impacted by maternal BMI, maternal weight, maternal systemic lupus erythematosus (SLE) and/or by certain medications such as low molecular weight heparin (for example: Lovenox®, Xaparin®, Clexane® and Fragmin®). The results of this testing, including the benefits and limitations, should be discussed with a qualified healthcare provider. Pregnancy management decisions, including termination of the pregnancy, should not be based on the results of this test alone. Please visit www.sequenom.com for the complete test limitations and our notice of privacy practices