During pregnancy, fetal DNA travels from the placenta to the mother’s blood stream and circulates along with her own DNA. VERACITY is a new generation non-invasive prenatal test that accurately measures the fetal cell-free DNA in the maternal blood to detect the presence of fetal aneuploidies and microdeletions. VERACITY has been validated for both single and twin pregnancies as well as pregnancies conceived through in-vitro fertilization (IVF).
The doctor or lab collects a blood sample from the mother’s arm and sends it to our state-of-the-art laboratories for analysis. At the laboratory, cell-free DNA is isolated from the mother’s blood and analyzed using our proprietary, new generation analytic and bioinformatic technology. Results are provided to your doctor in a few working days.
NEW GENERATION NON-INVASIVE PRENATAL TEST (NIPT)
- Can be done from 10 weeks of pregnancy
- Validated for singleton and twin pregnancies
- Applicable also for IVF pregnancies
- Preferred for its accuracy, robustness and affordability
PROPRIETARY TARGETED METHODOLOGY
VERACITY is a new generation non-invasive prenatal test (NIPT) for the detection of fetal chromosomal aneuploidies and microdeletions. It uses proprietary technology based on cutting-edge research and development in molecular genetics and bioinformatics. It was specifically designed by NIPD Genetics to avoid technical limitations and shortcomings of other NIPT.
VERACITY has been developed by an outstanding scientific team with over 25 years of experience in the field of prenatal diagnosis, molecular medicine, genomics, transcriptomics, methylomics and bioinformatics.
VERACITY uses novel Targeted Enrichment Technology that enables with unparalleled accuracy chromosomal aneuploidy detection as well as fetal fraction measurement. Targeted regions on selected chromosomes and chromosomal regions are captured, enriched and analysed for the detection of aneuploidies and microdeletions using our proprietary genomic and bioinformatic technologies.
Type of Test
|Screening that measures likelihood of trisomies 21, 18 and 13, and X, Y aneuploidies, and four microdeletions.||Screening test that measures likelihood of trisomies 21, 18, and 13.||Diagnostic test to determine chromosome abnormalities.|
|Blood draw from 10th week of pregnancy.||Blood draw and ultrasound between 11th and 14th weeks of pregnancy.||
CVS: Chorionic villus sampling between 10th and 12th weeks of pregnancy.
Amniocentesis: Sampling of amniotic fluid using a needle through the abdomen between 15th and 20th weeks of pregnancy.
|Safe. No risks to mother or child.||Safe. No risks to mother or child.||About 0.5% risk of fetal loss because of inherent invasiveness of the procedure used to obtain fetal material.|
|Higher than 99% for trisomy 21, 18 and 13 and several other anomalies.||80-95% for trisomy 21, 18 and 13.||Higher than 99% for trisomy 21, 18 and 13 and several other anomalies.|
UNIQUE FEATURES OF VERACITY
TARGETED GENOMIC ANALYSIS
VERACITY uses proprietary technology, specifically designed to avoid genomic regions with complex architecture that affect test performance. This overcomes problems associated with other NIPTs and increases the precision and accuracy of VERACITY.
HIGH READ DEPTH
Read-depth is the number of times a nucleotide in the genome is read during analysis. VERACITY captures DNA fragments from targeted regions on chromosomes of interest. So, it is able to read these selected regions at an extremely high read-depth which improves the statistical accuracy of the analysis and increases the sensitivity and specificity of VERACITY.
FETAL FRACTION MEASUREMENT
A proprietary bioinformatics software accurately calculates fetal fraction. Accurate fetal fraction measurement increases the robustness and reliability of VERACITY.
MULTI-ENGINE ANALYSIS PIPELINES
Proprietary bioinformatics pipelines analyze the sequencing data produced from each test. This multi-engine analysis increases the sensitivity and specificity of aneuploidy, microdeletion and fetal gender detection.
WHAT DOES VERACITY TEST FOR?
- Down syndrome (Trisomy 21)
- Edwards syndrome (Trisomy 18)
- Patau syndrome (Trisomy 13)
SEX CHROMOSOME ANEUPLOIDIES
- Turner syndrome (Monosomy X)
- Triple X syndrome (Trisomy X)
- Klinefelter syndrome (XXY)
- Jacobs syndrome (XYY)
- XXYY syndrome
- DiGeorge syndrome (22q11.2)
- 1p36 deletion syndrome
- Smith-Magenis syndrome (17p11.2)
- Wolf-Hirschhorn syndrome (4p16.3)
|Normal||10280||10280||10280||99.98% (99.93-99.998%)||100% (99.96 – 100%)|
|Trisomy 21||144||45||45||100% (92 – 100%)||100% (92 – 100%)|
|Trisomy 18||30||11||11||100% (69 – 100%)||100% (69 – 100%)|
|Trisomy 13||16||7||5||100% (48 – 100%)||71% (29 – 96%)|
SEX CHROMOSOME ANEUPLOIDIES
|Normal||6200||6200||6200||99.95% (99.86 – 99.99%)||100% (99.94 – 100%)|
|45, X||16||7||4||100% (40-100%)||57% (18-90%)|
Development and Validation Study 1
Number of Samples Correct Call Confidence Interval Normal 538 538 (100%) 99.9 — 100 T21 52 52 (100%) 93.2 — 100 T18 16 16 (100%) 79.4 — 100 T13 5 5 (100%) 47.8 — 100 Male 244 244 (100%) 99.9 — 100
Independent Validation Study 2
Number of Samples Correct Call Confidence Interval Normal 73 73 (100%) 95.1 — 100 T21 24 24 (100%) 85.8 — 100
Sex Chromosome Aneuploidies Validation Study
Number of Samples Correct Call Confidence Interval Normal 286 286 (100%) 99.9 — 100 Sex Chromosome
14 14 (100%) 93.2 — 100
- George Koumbaris, Elena Kypri, Kyriakos Tsangaras, Achilleas Achilleos, Petros Mina, Maria Neofytou, et al., and Philippos C Patsalis Cell-free DNA analysis of targeted genomic regions in maternal plasma for non-invasive prenatal testing of trisomy 21, trisomy 18, trisomy 13 and fetal sex. Clinical Chemistry 62:6, 848-855, 2016
- Manuscript under review.
- Manuscript under review.