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N Test

28 February 2019

Harmony™ Prenatal Test



Non-Invasive Prenatal Testing (NIPT) is chromosomal aneuploidy screening based on fetal DNA circulating in maternal blood. This method provides high sensitivity and low false positive rate. American College of Obstetrics and Gynecology (ACOG, 2015) and American College of Medical Genetics and Genomics (ACMG, 2016) recommend NIPT to screen for common aneuploidy including Chromosome 21 (Down’s syndrome), Chromosome 18 (Edward syndrome) and Chromosome 13 (Patau syndrome), but not for other chromosomes.
                 
CE-IVD marked Harmony™ Prenatal Test is targeted DNA analysis using DANSR™ and FORTE™ with microarray quantification which is used to evaluate the risk of trisomy 21, 18, 13 and sex chromosome aneuploidy such as Turner’s syndrome (Monosomy X), Triple X, Klinefelter syndrome (XXY). This technology helps to increase sensitivity and specificity for fetal chromosome aneuploidy detection. Harmony™ Prenatal Test can be used as early as 10 weeks gestation age. Moreover, it can be used in singleton, twin pregnancy, conceive through IVF from both self and surrogate egg.
                 
N Health provides non-invasive prenatal screening by Harmony™ Prenatal Test as below.






*This operation schedule is for the test performed at N Health head quarter, Bangkok.
**Above turnaround time does not include logistic time. For BDMS network hospitals, please contact N Health laboratory located at your hospitals.
References


 1. Committee Opinion No. 640: Cell-Free DNA Screening For Fetal Aneuploidy. Obstet Gynecol. 2015 Sep;126(3):e31-7.
2. Gregg AR, Skotko BG, Benkendorf JL, et al. Noninvasive prenatal screening for fetal aneuploidy, 2016 update: a position statement of the American College of Medical Genetics and Genomics. Genet Med. 2016 Oct;18(10):1056-65.
Stokowski R, Wang E, White K, et al. Clinical performance of non‐invasive prenatal testing (NIPT) using targeted cell‐free DNA analysis in maternal plasma with microarrays or next generation sequencing (NGS) is consistent across multiple controlled clinical studies. Prenatal Diagnosis. 2015;35(12):1243-1246.
 

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