NEW GENERATION NON-INVASIVE PRENATAL TEST (NIPT)

  • Can be done from 10 weeks of pregnancy
  • Single screening test for aneuploidies, microdeletions and point mutations
  • Validated for singleton and twin pregnancies
  • Applicable also for IVF pregnancies

VERAgene is the only non-invasive prenatal test that can simultaneously screen for aneuploidies, microdeletions and single gene diseases. The diseases screened by VERAgene are associated with moderate to severe phenotype with significant impact on the quality of life. By combining detection of aneuploidies and microdeletions with the screening of monogenic disorders, VERAgene provides a comprehensive solution to prospective parents.

WHAT IS VERAgene NIPT?

VERAgene is the first comprehensive non-invasive prenatal test (NIPT) that can simultaneously screen for aneuploidies, microdeletions and point mutations. The diseases screened by VERAgene are often severe with significant impact on the quality of life. VERAgene targets 500 mutations to screen for 50 monogenic disorders.

By combining detection of aneuploidies and microdeletions with the screening of monogenic disorders, VERAgene provides a comprehensive picture of the pregnancy using a single test.

ΗOW DOES IT WORK?

VERAgene needs a maternal blood sample, and a buccal swab sample from the biological father. The maternal blood contains cell-free DNA from both the mother and the fetus. This cell-free DNA is isolated and analyzed along with the father’s DNA sample for any potential genetic mutations using next generation sequencing. Sophisticated bioinformatics algorithms are then used to compute the risk of the fetus having a monogenic disease.

The results are sent to the clinician who communicates them to the parents and provides the necessary counseling.

Veragene
Conventional
Parental Tests
Cell-free DNA

Cell-free DNA extracted from mother’s blood and paternal DNA sample

Can detect several fetal genetic disorders

Screening combines...

Biochemical Screening Results, Ultrasound Findings and Other Parameters

Biochemical and ultrasound markers don’t exist for microdeletions and monogenic diseases

Highly Accurate >99% detection rate for aneuploidies
Low Accuracy 80-95% detection rate for aneuploidies
Safe No risk of fetal miscarriage
Risk for miscarriage through amniocentesis or CVS (0.5%)
Fast Can be done from 10 weeks
Screening for aneuploidies after the 12th week of pregnancy
First Trimester
Screening
Type of Test
Screening that measures the risk of trisomies 21, 18 and 13, X, Y aneuploidies, selected microdeletions, and a panel of 50 monogenic disorders. Screening test that measures likelihood of trisomies 21, 18, and 13.
Method
Genetic analysis of cell-free DNA from mother and DNA from father to determine the fetal risk for the tested conditions. Biochemical analysis of maternal blood ultrasound, and other parameters (e.g. maternal age) are used to estimate chance of being fetus affected by trisomies.
Sample
Blood sample from biological mother and buccal swab from biological father Blood sample from mother
Accuracy
Higher than 99% for trisomy 21, 18 and 13 sex chromosome aneuploidies and microdeletions. Higher than 99% (CI: 96% – 100%) PPV in detecting monogenic disorders. 80-95% for trisomy 21, 18 and 13.

UNIQUE FEATURES OF VERAgene

VERAgene captures, counts and analyses cfDNA fragments from selected genomic regions using targeted enrichment and next generation sequencing (NGS) with proprietary genetic and analytical tools. The main features of VERAgene are:

TARGETED GENOMIC ANALYSIS

VERAgene 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 VERAgene.

HIGH READ DEPTH

These fragments are then counted several hundreds of times using NGS to achieve very high statistical accuracy and precision.

ACCURATE FETAL FRACTION

VERAgene uses the high read-depth of maternal and fetal DNA counts from the genome to accurately measure the fetal contribution to the cfDNA. Accurate fetal fraction measurement protects from false results.

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 VERAgene SCREEN FOR?

  • ANEUPLOIDIES
    Condition Impact Cause
    Down syndrome (Trisomy 21) very severe Three copies of chromosome 21
    Edwards syndrome (Trisomy 18) very severe Three copies of chromosome 18
    Patau syndrome (Trisomy 13) very severe Three copies of chromosome 13
    Patau syndrome (Trisomy 13) very severe Three copies of chromosome 13
    Turner syndrome (Monosomy X) severe One chromosome X
    Triple X syndrome (Trisomy X) severe Three copies of chromosome X
    Klinefelter syndrome (XXY) severe Extra copy of chromosome X
    Jacobs syndrome (XYY) severe Extra copy of chromosome Y
    XXYY syndrome severe Extra copies of chromosomes X and Y
  • MICRODELETIONS
    Condition Impact Cause
    DiGeorge syndrome (22q11.2) severe Deletion of part of chromosome 22
    1p36 deletion syndrome severe Deletion of part of chromosome 1
    Smith-Magenis syndrome (17p11.2) severe Deletion of part of chromosome 17
    Wolf-Hirschhorm syndrome (4p16.3) severe Deletion of part of chromosome 4
  • Monogenic Diseases
    Condition Impact Genes
    3 Methylcrotonyl CoA Carboxylase Deficiency 1 severe MCCC1
    3 Methylcrotonyl CoA Carboxylase Deficiency 2 severe MCCC2
    Abetalipoproteinemia moderate to severe MTTP
    Arthrogryposis Mental Retardation Seizures severe SLC35A3
    Autosomal recessive polycystic kidney disease severe PKHD1
    Bardet Biedl syndrome 12 severe (blindness) BBS12
    Beta thalassemia very severe HBB
    Canavan disease severe ASPA
    Choreacanthocytosis moderate VPS13A
    Crigler Najjar syndrome, Type I very severe UGT1A1
    Cystic fibrosis very severe CFTR
    Factor V Leiden thrombophilia moderate F5
    Factor XI deficiency severe F11
    Familial dysautonomia moderate IKBKAP
    Familial Mediterranean fever moderate MEFV
    Fanconi anemia (FANCG-related) severe FANCG
    Glycine encephalopathy (GLDC-related) very severe GLDC
    Glycogen storage disease, Type 3 severe AGL
    Glycogen storage disease, Type 7 severe PFKM
    GRACILE Syndrome very severe BCS1L
    Inclusion body myopathy, Type 2 moderate GNE
    Isovaleric acidemia severe IVD
    Joubert syndrome, Type 2 severe TMEM216
    Junctional epidermolysis bullosa, Herlitz type severe LAMC2
    Leber congenital amaurosis (LCA5-related) severe LCA5
    Leydig cell hypoplasia [Luteinizing Hormone Resistance] moderate LHCGR
    Limb girdle muscular dystrophy, Type 2E severe SGCB
    Lipoamide Dehydrogenase Deficiency [Maple syrup urine disease, Type 3] severe DLD
    Lipoprotein lipase deficiency moderate LPL
    Long chain 3-hydroxyacyl-CoA dehydrogenase deficiency severe HADHA
    Maple syrup urine disease, Type 1B severe BCKDHB
    Methylmalonic acidemia (MMAA-related) very severe MMAA
    Multiple sulfatase deficiency very severe SUMF1
    Navajo neurohepatopathy [MPV17-related hepatocerebral mitochondrial DNA depletion syndrome] severe MPV17
    Neuronal ceroid lipofuscinosis (MFSD8-related) very severe MFSD8
    Nijmegen breakage syndrome severe NBN
    Ornithine translocase deficiency [Hyperornithinemia-Hyperammonemia-Homocitrullinuria (HHH) Syndrome]severe SLC25A15
    Peroxisome biogenesis disorders Zellweger syndrome spectrum (PEX1-related) severe PEX1
    Peroxisome biogenesis disorders Zellweger syndrome spectrum (PEX2-related) severe PEX2
    Phenylketonurea very severe PAH
    Pontocerebellar hypoplasia, Type 2E very severe VPS53
    Pycnodysostosis severe CTSK
    Pyruvate dehydrogenase deficiency (PDHB-related) severe PDHB
    Retinal Dystrophy (RLBP1-related) [Bothnia retinal dystrophy] severe (blindness) RLBP1
    Retinitis pigmentosa (DHDDS-related) severe (blindness) DHDDS
    Sanfilippo syndrome, Type D [Mucopolysaccharidosis IIID] severe GNS
    Sickle-cell disease very severe HBB
    Sjögren-Larsson syndrome severe ALDH3A2
    Tay-Sachs disease very severe HEXA
    Usher syndrome, Type 1F moderate (hearing loss) PCDH15

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NIPD Genetics - Privacy Policy

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Personal data for purposes of this Privacy Policy, is any information by which you can be individually identified, including, but not limited to, your name, profession, address, e-mail address, and telephone number.

You may contact NIPD Genetics Public Company Ltd at
NIPD Genetics Public Company Ltd
Neas Engomis 31
Engomi, Nicosia
2409, Cyprus

NIPD Genetics Data Protection Officer can be reached at dpo@nipd.com

This Privacy Policy applies only to the Sites as defined above and which are operated by NIPD Genetics. The NIPD Genetics Privacy Policy seeks to inform the users of its Sites of the following:

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This page informs you of our policies regarding the collection, use, and disclosure of personal data when you use our Sites and the choices you have associated with that data.

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Type of personal information NIPD Genetics may collect through its Sites

Information Collection And Use

We collect several different types of information for various purposes to provide and improve our Sites and services to you.

Personal Data

While using NIPD Genetics Sites, you may be asked to provide NIPD Genetics certain personally identifiable information that can be used to contact or identify you ("Personal Information"). Personal Information that might be used to identify you includes, but is not limited to:

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NIPD Genetics may disclose your personal data in the good faith belief that such action is necessary to:

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You can opt-out of having made your activity on the Service available to Google Analytics by installing the Google Analytics opt-out browser add-on. The add-on prevents the Google Analytics JavaScript (ga.js, analytics.js, and dc.js) from sharing information with Google Analytics about visits activity.

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Our Service does not address anyone under the age of 18 ("Children").

We do not knowingly collect personally identifiable information from anyone under the age of 18. If you are a parent or guardian and you are aware that your Children has provided us with Personal Data, please contact us. If we become aware that we have collected Personal Data from children without verification of parental consent, we take steps to remove that information from our servers.

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We may update our Privacy Policy from time to time. We will notify you of any changes by posting the new Privacy Policy on this page.

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You are advised to review this Privacy Policy periodically for any changes. Changes to this Privacy Policy are effective when they are posted on this page.

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If you have any questions about this Privacy Policy, please contact pdo@nipd.com

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