OVERVIEW

WHAT IS VERACITY

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 VERACITY

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

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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 on chromosomes of interest and reads these at an extremely high read-depth, improving the statistical accuracy of the analysis and increases the sensitivity and specificity.

Read-depth is the number of times a nucleotide in the genome is read during analysis.

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

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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.

VERACITY VS CONVENTIONAL PRENATAL TESTS

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WHAT DOES VERACITY TEST FOR?

AUTOSOMAL ANEUPLOIDIES

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

MICRODELETIONS

DiGeorge syndrome (22q11.2)
1p36 deletion syndrome
Smith-Magenis syndrome (17p11.2)
Wolf-Hirschhorn syndrome (4p16.3)

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TYPES OF CONDITIONS DETECTED BY VERACITY

Genetic conditions are caused by unwanted changes in the genome that happen during conception. Three types of genetic conditions are detected in Veracity:

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 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 table on the left).

AUTOSOMAL TRISOMIES
KARYOTYPENUMBERFOLLOW-UPCORRECTSPECIFICITYNPV/PPV
Normal10280102801028099.98% (99.93-99.998%)100% (99.96 – 100%) (NPV)
Trisomy 211264444100% (92 – 100%)100% (92 – 100%) (PPV)
Trisomy 18241010100% (69 – 100%)100% (69 – 100%) (PPV)
Trisomy 131675100% (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

ORDER FORM
ACCEPTED MATERIAL

2x 10 ml blood in BCT cell free DNA tubes

TURNAROUND TIME

4-7 working days from sample receipt to the laboratory

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

*Our tests can be ordered through our local partners. Please choose one of the locations listed below

OUR NETWORK