Accuracy

The PrenatalSafe Karyo technology ensures the best result

High Resolution Sequencing:

˜ 50 Millions of unique reads

Exceptional performance:

Sensitivity and specificity > 99%

Accurate measurement of Fetal Fraction (FF)

Low limit of detection:

highly accurate at low cfDNA quantity (FF:2%)

Low incidence of inconclusive results (< 1%)

Comprehensive:

detection of both genome-wide chromosomal abnormalities and single-gene disorders (inherited or de novo).


Detects cromosomal abnormalities at low fetal fraction (<4%)

Other NIPT approaches requires a FF>4% for a reportable result

Fetal Fraction
A Genoma’s study1 demonstrated a six-fold increased incidence of aneuploidy (6.9% vs. 1.1%, p<0.001) was observed in samples with 2% <FF <4% vs. samples with FF=4%. These high risk pregnancies would have not been identified if the 4% FF cut-off had been used.

Samples at low FF are at higher risk of aneuploidy

An increased incidence (4-10 fold higher) of fetal aneuploidy has been reported in samples that failed to provide a reportable result from cfDNA testing due to low fetal fraction. This underscores the importance of testing samples with a very low amount of fetal cfDNA, using a NIPT method with with a demonstrated accuracy at low FF, as PrenatalSAFE®Karyo .

Fetal Fraction
The ability to screen samples at low FF reduces the incidence of test cancellations and shorten the time required for the diagnosis of aneuploidy by invasive prenatal testing

1) Fiorentino et al. The importance of determining the limit of detection of non-invasive prenatal testing methods. Prenat Diagn. 2016 Apr;36:304-11