VERAgene - a comprehensive NIPT test that screens for 100 monogenic diseases
During pregnancy, cell-free fetal DNA travels from the placenta and circulates in the mother’s blood along with her own cell-free DNA. This discovery led to the development of Non-Invasive Prenatal Tests (NIPT). NIPT is a test taken by a pregnant woman that screens for certain genetic conditions in the fetus before birth. The benefit of NIPT is that it is performed much earlier during pregnancy and is more accurate than traditional screening tests currently in practice. While there are many NIPTs for Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18) and Patau syndrome (Trisomy 13), sex chromosome (X & Y) aneuploidies (chromosomal changes) and microdeletions (loss of a small section of a chromosome), an NIPT test that stands out is VERAgene.
Designed and developed by NIPD Genetics, VERAgene is the only comprehensive NIPT test that can simultaneously screen for common aneuploidies, selected clinically significant microdeletions and a panel of 100 single gene (monogenic) diseases, like β-thalassemia, cystic fibrosis and phenylketonurea. Aneuploidies such as Down syndrome are screened by many NIPT and traditional screening tests due to their severity and incidence rate. However, the 4 microdeletions and the single gene diseases that are additionally detected by VERAgene cannot be detected prenatally by any other means apart from NIPT, as biochemical or ultrasound indications for many of these disorders are often non-existent. Additionally, they are not associated with maternal age so they can manifest at any age group – even ones that are not traditionally referred for prenatal screening. Consequently, if these genetic conditions are not detected before birth, it could take a lot of time for examination and specific testing for a person to be diagnosed; time that could have otherwise been spent receiving the appropriate treatment.
The 100 monogenic diseases screened by VERAgene are often severe with significant impact on the quality of life. These genetic diseases exhibit symptoms such as congenital anomalies, developmental delays, hearing loss, blindness and failure to thrive. VERAgene screens for autosomal recessive and X-linked diseases. In autosomal recessive conditions, both parents have to be carriers of the same disease variant (genetic change) for their baby to be affected. In X-linked conditions, where the variant is on the X chromosome, the variant is often passed from carrier, unaffected mothers to their male offsprings. As males only have one X chromosome, they are always affected. Importantly, people who are carriers do not exhibit any disease symptoms. Unless they have had pre-conception testing, have a family history of a specific condition, or live in regions where certain diseases have high prevalence – such as β-thalassemia in the Mediterranean or Tay-Sachs in Israel – they won’t necessarily know their status, or their risk of having an affected pregnancy. The cumulative incidence rate of all 100 monogenic diseases, aneuploidies and microdeletions detected by VERAgene is approximately 1 in 50 in moderate to high-risk pregnancies. Thus, VERAgene provides a high value to doctors and expecting parents by providing them with a comprehensive picture of the pregnancy with a single test that helps them make informed decisions early on during the pregnancy.
VERAgene is based on the same proprietary technology as NIPD Genetics’s new generation NIPT, VERACITY, which tests for aneuploidies in 21, 18, 13, X and Y chromosomes and select microdeletions. VERAgene can be performed as early as the 10th week of gestation and it only requires a blood sample from the biological mother and a buccal swab sample from the biological father. These samples are sent from the clinician to the NIPD Genetics laboratory for analysis. The maternal blood contains cell-free DNA from both the mother and the fetus. Cell-free fetal DNA is isolated from the maternal blood and is analyzed along with the father’s DNA sample for any potential variants. The results are sent back to the clinician within 7 working days, who then communicates them to the parents and provides the necessary counselling. Like other screening tests, a positive result indicates that there is higher chance of the embryo being affected – it doesn’t provide a diagnosis – and it should be confirmed with an invasive procedure, such as amniocentesis. The sample taken from this procedure is analyzed using the same advanced technology of NIPD Genetics without any additional charge, as part of the complete testing offered. VERAgene can be performed in singleton and twin pregnancies, and is also applicable for self-IVF pregnancies.
The advantage VERAgene offers – to screen for monogenic diseases which do not have any age-associated risk in addition to aneuploidies and microdeletions – is of significant importance for patients and healthcare practitioners alike. VERAgene combines the unparalleled accuracy and superiority of NIPD Genetics’s technology in a testing panel that provides a cost-effective, comprehensive analysis that opens a new chapter in the field of non-invasive prenatal screening.
VERAgene was launched by NIPD Genetics in 2018 and screened for aneuploidies, microdeletions and 50 single gene diseases of autosomal recessive inheritance. In January 2020, VERAgene was expanded to screen for aneuploidies, microdeletions and 100 single gene diseases of autosomal recessive and X-linked inheritance.
To learn more about all the conditions screened by VERAgene, please visitwww.nipd.com/VERAgene.NIPT results, possible next steps and clinical management should always be fully discussed with your healthcare provider.
NIPD Genetics values your interest in NIPD Genetics, its products and its services. NIPD Genetics takes the protection of your data seriously.
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 firstname.lastname@example.org
Type of personal information NIPD Genetics may collect through its Sites
The ways by which NIPD Genetics collects, uses or shares such information
Steps NIPD Genetics takes to protect its sites’ users personal information
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.
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.
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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If you send us a query via our Contact us form, your email address, the content and any follow up emails are retained indefinitely.
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www.nipd.com uses the collected data for various purposes:
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Your information, including personal data, may be transferred to — and maintained on — computers located outside of your province, country or other governmental jurisdiction where the data protection laws may differ than those from your jurisdiction.
If you are located outside Cyprus and choose to provide information to us, please note that we transfer the data, including personal data, to Cyprus and process it there.
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NIPD Genetics complies with the protection of personal data regulation and will not sale or trade your personal data.
NIPD Genetics may disclose your personal data in the good faith belief that such action is necessary to:
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We may employ third party companies and individuals to facilitate, maintain or operate our Sites ("Service Providers"), to provide the SItes on our behalf, to perform service-related services or to assist us in analyzing how our Sites is used.
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Links to Other Sites
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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.