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hamilelik, gebelik testi, DNA testi, NIPD

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VERACITY New Generation Non-Invasive Prenatal Test

VERACITY is a new generation non-invasive prenatal test for the detection of fetal chromosomal aneuploidies applicable to single and twin pregnancies.
It uses proprietary technology based on cutting-edge research and development in Molecular Genetics and Diagnostics.
It was designed by NIPD Genetics to avoid the shortcomings of other NIPT technologies.

It is preferable due to reasons below:

It can be performed after the 10th week of gestation.
It can be performed on IVF pregnancies
It is accurate, robust and has an affordable price


 

AUTOSOMAL ANEUPLOIDIES
 
Trisomy 21
Down syndrome
Trisomy 18
Edwards syndrome
Trisomy 13
Patau syndrome
 
 


SEX CHROMOSOME ANEUPLOIDIES (only in single pregnancies)
 
Monosomy X
Turner syndrome
Trisomy X
Triple X syndrome
XXY
Klinefelter syndrome
XYY
Jacob syndrome
 

 


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

Comparison of prenatal testing methodologies

  VERACITY First Trimester Screening Invasive Prenatal Diagnosis
Type of Test Screening test measures likelihood of trisomies 21, 18 and 13, and X, Y aneuploidies. Screening test that measures likelihood of trisomies 21, 18, and 13. Diagnostic test to determine chromosome abnormalities.
Testing Method 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.
Testing Risks 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.
Testing Accuracy Higher than 99% for trisomy 21, 18 and 13. 80-95% for trisomy 21, 18 and 13. Higher than 99% for trisomy 21, 18 and 13.


Validation studies

Development and Validation Study1

  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 Study2

  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 Study3

  Number of Samples Correct Call Confidence Interval
Normal 286 286 (100%) 99.9 — 100
Sex Chromosome
Aneuploidies
14 14 (100%) 93.2 — 100
1- 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
2- Manuscript in preparation.
3- Manuscript in preparation.
 


VERACITY has been developed by a scientific team with over 25 years of experience in the field of prenatal diagnosis, molecular medicine, genomics, trascriptomics, methylomics and bioinformatics .
VERACITY uses novel Targeted Enrichment Technology that enables superior aneuploidy detection and unparalleled accuracy in fetal fraction measurement. Targeted regions on chromosomes 21, 18, 13, X and Y are captured, enriched  and analysed for aneuploidies using our proprietary genomic and bioinformatic technologies 

 
  VERACITY Conventional Prenatal Tests
Screening Cell free DNA isolated from mothers plasma Biochemical results, ultrasound findings and other parameters
Accuracy Highly accurate >99% detection rate Low accuracy, 80-95% accuracy
Reliability No miscarriage risk There is a %0.5 possibilitiy of miscarriage due to amniocenteses or CVS
When applicable Applicable after the 10th week of gestation Applicable after the 10th week of gestation
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FAQ
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Targeted Genomic Analyzes

 

VERACITY, uses specifically designed and accredited internationally accredited target capture sequences(TACS) in order to avoid CNVs, repetitive elementss and complex genomic structures. This target specific approach increases sensitivity, reliability and accuracy of VERACITY by ensuring to overcome the issues other NIPTs have

Detail
 
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High Read-Depth

 

Read-depth is the number of times a nucelotide in the genome is read during analysis. VERACITY captures DNA fragments only 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.

Detail

 

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Fetal Fraciton Measurement

 

VERACITY uses informative loci to reliably distinguish fetal cfDNA from maternal cfDNA. A proprietary bioinformatics software uses the high read depth counts of these informative loci to accurately calculate the fetal fraction. Accurate fetal fraction measurements raise the robustness and reliability of VERACITY.

Detail

 

FAQ

HOW VERACITY WORKS?
WHICH GENETIC ABNORMALITIES VERACITY CAN DETECT?
What is the accuracy and reliablity of VERACITY?
Is there a age limit to take VERACITY?
When the soonest I can take VERACITY test?
Why should I consider VERACITY
How can I take a VERACITY test?
WHAT ARE THE NIPT METHODS?
WHY TO PREFER VERACITY?
VERACITY DESIGN FEATURES?
WHAT IS THE DIFFERENCE BETWEEN CONVENTIONAL PRENATAL SCREENING OPTIONS AND VERACITY?
WHAT ARE VALIDATION STUDIES ABOUT VERACITY?
WHY FETAL FRACTIONS ARE IMPORTANT FOR A CORRECT RESULT IN NIPT TECHNOLOGIES?
EVALUATION OF REFERENCE MATERIALS BY VERACITY
DOES NIPT TECHNOLOGY RESULT IN IVF PREGNANCY?
HOW CAN I REACH TO THE ARTICLES ABOUT LIMITATIONS IN OTHER NIPT TECHNOLOGIES?
Location
ADRESİMİZ

Atatürk mah. ErtuğrulGazi Sk. 2B Metropol İstanbul C1 Blok D:235 Ataşehir/İstanbul

  TELEFON : +90 216 515 36 96

  E-POSTA : info@elsiegenetic.com

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