About the Test
The MaterniT21 PLUS test, developed and validated by Sequenom CMM, is a laboratory-developed test (LDT) that analyzes circulating cell-free DNA extracted from a maternal blood sample. The test detects an increased amount of chromosomal 21, 18, and 13 material.2, 10
Test Method
Circulating cell-free DNA is purified from the plasma component of anti-coagulated maternal whole blood. It is then converted into a genomic DNA library for the determination of chromosome 21, 18, and 13 representation based on massively parallel genomic sequencing.3
Unique, Proven Circulating Cell-Free Fetal Nucleic Acid (ccff) Technology
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Early studies showed ~3-6% of circulating fetal DNA in maternal plasma. Recent studies indicate it may be >10%7,8
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Analyzes circulating cell-free DNA from maternal blood in women at increased risk for fetal chromosomal aneuploidy
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Sequenom holds an exclusive platform-independent license for fetal nucleic acid detection in serum and plasma, branded under the name SEQureDx™ technology
Trisomy 18 and Trisomy 13
Recent published data indicate that the core technology which underlies the MaterniT21 PLUS test also has the capability to detect other aneuploidies, such as trisomy 18 and trisomy 13. If either of these aneuploidies is detected by the MaterniT21 PLUS test, Sequenom CMM will be reporting these results to the physician. The performance of the test for trisomy 18 and trisomy 13 has been clinically validated.10
Our Test
This laboratory-developed test was developed and its performance characteristics determined by Sequenom CMM. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although laboratory-developed tests to date have not been subject to U.S. FDA regulation, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. This laboratory is accredited and certified to perform high complexity clinical laboratory testing.