OVERVIEW

WHAT IS VERACTIY

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).

HOW IT WORKS

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.

UNIQUE FEATURES OF VERACTIY

VERACITY technology enables with unparalleled accuracy chromosomal aneuploidy detection as well as fetal fraction measurement.

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Targeted genomic analysis
VERACITY is designed to avoid genomic
regions with complex architecture that
affect test performance.
This increases precision and accuracy.

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High-read depth
VERACITY captures DNA fragments
from targeted regions and reads them
at high read-depth, improving statistical
accuracy and increases sensitivity and specificity.

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Fetal fraction measurement
A proprietary bioinformatics software
accurately calculates fetal fraction which
increases the robustness and reliability.

VERACTIY VS CONVENTIONAL PRENATAL TESTS

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WHAT DOES VERACTIY TEST FOR?

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ANEUPLOIDIES
CONDITIONCAUSE
Down syndrome (Trisomy 21)Three copies of chromosome 21
Edwards syndrome (Trisomy 18)Three copies of chromosome 18
Patau syndrome (Trisomy 13)Three copies of chromosome 13
Turner syndrome (Monosomy X)One chromosome X
Triple X syndrome (Trisomy X)Three copies of chromosome X
Klinefelter syndrome (XXY)Extra copy of chromosome X
Jacobs syndrome (XYY)Extra copy of chromosome Y
XXYY syndromeExtra copies of chromosomes X and Y
MICRODELETIONS
CONDITIONCAUSE
DiGeorge syndrome (22q11.2)Deletion of part of chromosome 22
1p36 deletion syndromeDeletion of part of chromosome 1
Smith-Magenis syndrome (17p11.2)Deletion of part of chromosome 17
Wolf-Hirschhorn syndrome (4p16.3)Deletion of part of chromosome 4

CLINICAL PERFORMANCE

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 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.

Validation studies have been conducted and are available (see below).

AUTOSOMAL TRISOMIES
KARYOTYPENUMBERFOLLOW-UPCORRECTSPECIFICITYNPV/PPV
Normal10280102801028099.98% (99.93-99.998%)100% (99.96 – 100%) (NPV)
Trisomy 211444545100% (92 – 100%)100% (92 – 100%) (PPV)
Trisomy 18 301111100% (69 – 100%)100% (69 – 100%) (PPV)
Trisomy 13 1675100% (48 – 100%)71% (29 – 96%) (PPV)
SEX CHROMOSOME ANEUPLOIDIES
KARYOTYPENUMBERFOLLOW-UPCORRECTSPECIFICITYNPV/PPV
Normal62006200620099.95% (99.86 – 99.99%)100% (99.94 – 100%) (NPV)
45, X1674100% (40-100%)57% (18-90%) (PPV)
47, XXX622--
47, XXY1044--
47, XYY30---
48, XXYY111--
*NPV negative predictive value, PPV positive predictive value

HOW CAN I TAKE THE VERACITY TEST?

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Be at least 10 weeks pregnant

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Ask your doctor about taking VERACITY

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Visit your doctor to have a single blood draw

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We will analyze the blood sample in our laboratories

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We will send your results to your doctor in 4-7 working days

ACCEPTED MATERIAL

2x 10 ml blood in BCT cell free DNA tubes

TURNAROUND TIME

4-7 working days

DEVELOPMENT AND VALIDATION STUDY

DEVELOPMENT AND VALIDATION STUDY
DEVELOPMENT AND VALIDATION STUDY
Type of SampleNumber of SamplesCorrect CallConfidence Interval
Normal538538 (100%)99.9 — 100
T215252 (100%)93.2 — 100
T181616 (100%)79.4 — 100
T1355 (100%)47.8 — 100
Male244244 (100%)99.9 — 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

INDEPENDENT VALIDATION STUDY

INDEPENDENT VALIDATION STUDY
INDEPENDENT VALIDATION STUDY
Type of SampleNumber of SamplesCorrect CallConfidence Interval
Normal7373 (100%)95.1 — 100
T212424 (100%)85.8 — 100
*Manuscript under review

SEX CHROMOSOME ANEUPLOIDIES VALIDATION STUDY

SEX CHROMOSOME ANEUPLOIDIES VALIDATION STUDY
SEX CHROMOSOME ANEUPLOIDIES VALIDATION STUDY
Type of SampleNumber of SamplesCorrect CallConfidence Interval
Normal286286 (100%)99.9 — 100
Sex Chromosome Aneuploidies1414 (100%)93.2 — 100
*Manuscript under review

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