NACE Non-invasive prenatal test

Non-invasive prenatal screening helps to avoid unnecessary amniocentesis

Overview

NACE
Benefits
Indications

What is NACE?

NACE is a non-invasive prenatal screening test for the most frequent chromosomal abnormalities. The test is non-invasive, meaning that there is no risk to the fetus.

A simple blood draw from the mother allows free fetal DNA circulating in the maternal bloodstream to be detected via next-generation sequencing (NGS) technology and our proprietary bioinformatic analysis tool.

What does NACE detect?

NACE detects abnormalities in chromosomes 21, 18, 13 and the most common anomalies in the sexual chromosomes (X and Y).
NACE 24 analyzes all chromosomes
NACE 24 Extended analyzes all 24 chromosomes and identifies microdeletions associated with 6 major genetic syndromes.

NACE can be used for:

Single pregnancies
Twin pregnancies
Can give results with fetal fraction under 4%
Natural conception
IVF
Egg donation
Women of all ages
Women of all ethnicities
Women of all body mass index
Suitable for cases of consanguinity

Why use a non-invasive prenatal test

Prevent the need for 98% of invasive tests in patients at risk for trisomy 21 (Down Syndrome)
Reduces the number of miscarriages caused by amniocentesis or chorionic villus sampling (CVS)
Can give results with fetal fraction under 4%
NACE has the highest informativity rate in the market: we obtain results for 99.9% of the analyzed samples
NACE Extended 24 incorporates the detection of all 24 chromosomes and identifies five microdeletions that are associated with major genetic syndromes
More reliable than 1st trimester combined screening. The false positive rates of conventional tests, including biochemical screening, mean that 1 in every 20 women who test positive for Down syndrome will actually be carrying a healthy baby.
Avoid a false sense of security: Of every 20 women carrying a baby with Down syndrome, 3 will test negative by biochemical screening.

Methodology

Who is NACE suitable for?

Several scientific studies support the use of non-invasive prenatal testing for all pregnant women.

An abnormal result in their first-trimester screen.
A previous Down´s syndrome pregnancy
A suspicious ultrasound finding.

(Gregg, et al. Genet Med. 2016)

Test Limitations

cfDNA screening is considered a screening test and not a diagnostic test.
False non-invasive prenatal screening (NIPT) results: fetoplacental mosaicism, maternal chromosomal abnormalities, vanishing twin syndrome and/or errors associated with the procedures.
Low-molecular-weight heparin can interfere with the analysis. If the patient is taking heparin during pregnancy, the recommendation is to perform the blood draw before heparin administration.

Specialists’ documents

Relevant related studies:

Milan M, Mateu E, Blesa D, Clemente-Ciscar M, Simon C. Fetal sex determination in twin pregnancies using cell free fetal DNA analysis. Prenat Diagn. 2018 Apr 23.

Gregg AR et al. Genet Med 2016; 18:1056-65.

Bianchi et al. N Engl J Med. 2014 27;270 (9):799-808.

Nicolaides KH. Prenat Diagn 2011; 31:7-15-

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Screens for the most common chromosomal abnormalities without risk to your child

Highest informativity rate in the market: we obtain results for 99.9% of the analyzed samples

Available from week 10 of pregnancy

Reduces unnecessary amniocentesis