Performance Data

MaterniT21 PLUS Test Expected Performance in Laboratory

The MaterniT21 PLUS test, following CLIA guidelines for test evaluation, has shown high accuracy, precision, sensitivity and specificity. Each step of the testing process uses built-in controls to ensure the quality of test results.

The technology and data behind the MaterniT21 PLUS test are extensively studied and well published.^7,8,9,10

Published Clinical Studies for the MaterniT21 PLUS Test

Multiplexed massively parallel sequencing for the prenatal detection of fetal aneuploidy from maternal plasma. 
Zwiefelhofer T, Tynan J, Cagasan L, van den Boom D, Tang L, Chen Y, Deciu C, Ehrich M. Poster presented at: Annual Meeting of the American Society of Human Genetics (ASGH); 2010; Washington, DC.

Noninvasive detection of fetal trisomy 21 by sequencing of DNA in maternal blood: a study in a clinical setting.
Ehrich M, Deciu C, Zwiefelhofer T, Tynan JA, Cagasan L, Tim R, Lu V, McCullough R, McCarthy E, Nygren AO, Dean J, Tang L, Hutchison D, Lu T, Wang H, Angkachatchai V, Oeth P, Cantor CR, Bombard A, van den Boom D. Am J Obstet Gynecol. 2011 Mar;204(3):205.

DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation.    
Palomaki GE, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Deciu C, Grody WW, Nelson SF, Canick JA. Genet Med. Vol 13:No 11. Nov 2011.

DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13, as well as Down syndrome: an international collaborative study.
Palomaki GE, Deciu C, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Grody WW,  Nelson SF, Canick JA.Genet Med  2012 Mar 1.