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 is a leading, innovative biotechnology company that designs, develops, and provides a
broad spectrum of healthcare services to its customers through its expansive portfolio of molecular
and clinical laboratory tests in all disciplines.
At NIPD Genetics we are committed to protecting and respecting our customer’s privacy and personal
information. Personal information or personal data means any information that identifies, relates to,
describes, is capable of being associated with, or could be reasonably linked, directly or indirectly, with
a particular individual, such as name, identification number, location data, an online identifier or to
one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social
identity of that individual.
NIPD Genetics collects and processes your personal information according to the General Data
Protection Regulation (EU) 2016/679 and the Cypriot law providing for the protection of natural
persons with regards to the processing of personal data and for the free movement of such data (L.
125(I)/2018). The following principles lie at the heart of our approach to handling personal data:
Lawfulness, fairness and transparency – We collect and process personal data in a lawful
transparent manner and clearly communicate to our customers how their personal data will be
Purpose limitation – We only use personal data for the purpose for which they have been
Data minimization – We only collect the data that is absolutely necessary in relation to
purposes for which they are processed.
Accuracy – We take every reasonable step to ensure that personal data collected are
and up to date.
Storage limitation – We do not keep personal data for longer than it is needed. Personal
periodically reviewed and erased if they are not needed or anonymized and stored for scientific
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in place to ensure that personal data are adequately protected from any unauthorised or illegal
processing and accidental loss, destruction or damage.
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and promote internal practices to achieve the highest standards for personal data privacy.
NIPD Genetics has appointed a Data Protection Officer (DPO) who is responsible for overseeing and
ensuring that personal information is collected and processed in line with these principles. The contact
details of the Data Protection Officer (DPO) can be found below:
Postal address: 31 Neas Engomis street, 2409 Engomi, Nicosia, Cyprus
Telephone number: + 357 22266888
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you do not agree with our policies, procedures and practices as described, you can choose not to
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We collect and process several types of personal information from and about users of our websites
and of our products and services, including:
Personal and sensitive information: some of our products and services may involve testing
biological samples that we or our customers use to create test reports, genotyping or sequencing
services for research or clinical purposes and the receipt, creation, or analysis of genomic or other
data derived from samples, including through our customer’s use of our software as a service
product. In receiving samples and providing our products and services, we may obtain your name
and surname, date of birth, email address, home address, telephone number, gender, ethnicity
and other health related information.
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Your personal information is collected by NIPD Genetics for the following purposes:
To provide you with our products and services, respond to your inquiries or fulfill your requests
and otherwise manage your relationship with us. The legal basis for processing is to meet the
requirements of a contract, to comply with our legal obligations and/or because we have a
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To communicate with you about content and product offerings, newsletters and event invitations
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To monitor and record information relating to the use of our products and services, including our
website. The legal basis for processing is our legitimate interest in order to improve our products
and services and our website for individuals.
To provide our products and services, NIPD Genetics may collect, receive and process biological
samples to isolate and sequence DNA. NIPD Genetics may then store resulting genetic information
and use genetic information to provide our products and services. In some cases, NIPD Genetics may
provide interpretations of genetic information on behalf of its customers, including healthcare
providers. This is only done pursuant to a written contract or a Sample Information Form with a
patient’s informed consent and is subject to applicable legal and ethical safeguards.
This sensitive information described above is collected by NIPD Genetics for the following purposes:
To provide support and maintenance services to customers who use our products and services –
The legal basis for processing is to meet the requirements of a contract.
To provide genotyping and sequencing services and analysis for our customers, including
healthcare providers. The legal basis of this processing is to meet the requirements of a contract
or as allowed in the Sample Information Form with a patient’s informed consent.
To conduct genotyping and sequencing services and analysis for quality control, process and
product development and improvements, and optimization in our labs to reflect quality
improvements and advances in our technology. The legal basis for processing is the patient’s
informed consent given through the Sample Information Form.
Transfer of Data
Your information, including personal data, may be transferred to - and maintained on - computers
located outside 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.
agreement to that transfer.
NIPD Genetics will take all reasonable steps necessary to ensure that your data is treated securely and
an organization or a country unless there are adequate controls in place including the security of your
data and other personal information.
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NIPD Genetics complies with the General Data Protection Regulation and will not sell or trade your
NIPD Genetics may disclose your personal information in the good faith that such action is necessary:
To comply with a legal obligation
To protect and defend the rights or property of NIPD Genetics
To prevent or investigate possible wrongdoing in connection with our products and services
To protect against legal liability
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We are committed to protecting the security of the information we collect, and we take reasonable
physical, technical, and administrative safeguards such as data anonymization and encryption to help
protect personal information from unauthorized or inappropriate access or use. It is your
responsibility to protect the confidentiality of your passwords, and any other access features
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PERSONAL DATA RETENTION
We may retain collected information even after you remove it from the website, our Services, or our
Products, to comply with applicable law, to resolve disputes, to enforce any rights in connection with
Use, or an applicable contract between us and you or your organization. How long we retain specific
personal information varies depending on the purpose for its use and we may delete or retain your
personal information in accordance with applicable law.
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These third parties have access to your Personal Data only to perform these tasks on our behalf and
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of every site you visit.
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We will let you know via email and/or a prominent notice on our website, prior to the change
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YOUR LEGAL RIGHTS
NIPD Genetics ensures that it can respond immediately to requests that you make for the exercise of
your legal rights in accordance with data protection laws. These rights are as follows:
The right to withdraw consent at any time – in cases where processing is based on your
The right of access – at any given time you have the right to know what information about you
we hold and receive information about the processing activities we perform
The right to rectify – you have the right to correct, amend and complete personal data that is
The right to erasure (“right to be forgotten”) – you can request that your personal information
The right to object – you can object at any time to our processing of your personal information
The right to restriction of processing – this applies in the event:
You dispute the accuracy of your personal information and until it is verified
You oppose to the deletion of personal data and ask instead to delete the use of it
The personal information is no longer necessary for us
You object to the processing and we are considering whether our legitimate grounds
for processing prevail over the reasons you oppose to the processing
The right to data portability – at any given time you have the right to receive the personal
information we hold about you in a structured, commonly used and machine-readable format
(pdf, word etc.). You also have the right to request that these data are transferred to another
service in a safe and secure way
You also have the right to lodge a complaint at any time to the Office of the Commissioner for Personal
We encourage you to contact us, should you wish to practice any of your legal rights or you have any