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 diseases, 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 over 2,000 mutations to screen for 100
monogenic diseases.
By combining detection of aneuploidies and microdeletions with the screening of monogenic diseases,
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 Prenatal 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 Accuracy80-95% detection rate for aneuploidies
SafeNo risk of fetal miscarriage
Riskfor miscarriage through amniocentesis or
CVS
(0.5%)
EarlyCan be done from the 10th week of pregnancy
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 100 monogenic diseases.
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 trisomies 21, 18 and 13, sex chromosome aneuploidies and
microdeletions. Higher than 99% in detecting monogenic diseases.
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.
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
and
transparent manner and clearly communicate to our customers how their personal data will be
used.
Purpose limitation – We only use personal data for the purpose for which they have been
collected.
Data minimization – We only collect the data that is absolutely necessary in relation to
the
purposes for which they are processed.
Accuracy – We take every reasonable step to ensure that personal data collected are
accurate
and up to date.
Storage limitation – We do not keep personal data for longer than it is needed. Personal
data are
periodically reviewed and erased if they are not needed or anonymized and stored for scientific
research purposes.
Integrity and confidentiality (security) – Appropriate technical and organizational
measures are
in place to ensure that personal data are adequately protected from any unauthorised or illegal
processing and accidental loss, destruction or damage.
Accountability – We, at NIPD Genetics, are committed to compliance with all legal
requirements
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
By accessing or using our products or services, or by transmitting information to us by email or other
electronic means, you accept our policies, procedures and practices described in this Privacy Policy. If
you do not agree with our policies, procedures and practices as described, you can choose not to
access or use our products or services or not to transmit personal information to us.
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
of
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.
Computer, device and browsing information: as you interact with our products and services
online, including this website, we may use automatic data collection technologies to collect certain
information about your computer or device, as well as browsing actions and usage patterns. This
data may include your IP address, browser type or version.
The technologies we use for this automatic data collection may include cookies. You can control
cookies by adjusting your cookies settings.
Information about children
If you are under 18 years of age, do not register on our website or provide any information about
yourself to us. We do not provide our products or services directly to children or proactively collect
their personal information. Despite this prohibition, it is possible that we may sometimes be given
information about children while handling samples from our customers in our clinical labs, or through
use of our products and services by our customers and partners. If we become aware that we have
inadvertently collected personal information from children under the age of 18, without parental
consent, we will take the necessary steps to delete it as soon as possible in compliance with applicable
laws.
LEGAL BASIS FOR PROCESSING OF YOUR PERSONAL INFORMATION
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
legitimate interest in responding to requests for information about our products and services.
To communicate with you about content and product offerings, newsletters and event invitations
which are relevant to your interests and in line with your preferences. The legal basis for processing
is the individual’s explicit consent prior to sending the information and managing individuals
preferences.
To process and respond to complaints. The legal basis for processing is to meet a legal obligation.
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.
Your consent to this Privacy Policy followed by your submission of such information represents your
agreement to that transfer.
NIPD Genetics will take all reasonable steps necessary to ensure that your data is treated securely and
in accordance with this Privacy Policy and no transfer of your personal information will take place to
an organization or a country unless there are adequate controls in place including the security of your
data and other personal information.
Disclosure of Data
NIPD Genetics complies with the General Data Protection Regulation and will not sell or trade your
personal information.
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
COOKIES AND OTHER TRACKING TECHNOLOGIES
Cookies are files with small amount of data which may include an anonymous unique identifiers.
Cookies are sent to your browser when you visit a website and stored on your device. Tracking
technologies used on the website are beacons, tags and scripts, to collect and track information and
to improve and analyze our websites.
We use cookies and similar tracking technologies to track the activity on our websites and collect
certain information. This includes information about the computer or device you are using, such as
Internet protocol (IP) address, information about the browser type or version, the pages of our
website that you visit, the time and date of your visit, the time spent on those pages, unique device
identifiers and other diagnostic data.
You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However,
if you do not accept cookies, you may not be able to use some portions of our websites.
Examples of Cookies we may use:
Session Cookies. We use Session Cookies to operate our websites.
Preference Cookies. We use Preference Cookies to remember your preferences and various settings.
Security Cookies. We use Security Cookies for security purposes.
Visitor behavior cookies. To understand how visitors use and navigate the websites
Keyword cookies. To understand how visitors discover the websites.
ANALYTICS
We may use third-party Service Providers to monitor and analyze the use of our websites.
Google Analytics
Google Analytics is a web analytics service offered by Google that tracks and reports website traffic.
Google uses the data collected to track and monitor the use of our service. This data is shared with
other Google services. Google may use the collected data to contextualize and personalize the ads of
its own advertising network.
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.
For more information on the privacy practices of Google, please visit the Google Privacy & Terms web
page
SECURITY OF DATA
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
associated with your access or use of the website or our products and services, as well as to adhere
to any applicable Terms of Use or other contract between us and you or your organization.
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
the website, our Services, or our Products, and to use as provided in this Privacy Policy, the Terms of
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.
SERVICE PROVIDERS
We may employ third party companies and individuals to facilitate, maintain or operate our websites
(“Service Providers”), to provide the websites on our behalf, to perform service-related services or to
assist us in analyzing how our websites are used.
These third parties have access to your Personal Data only to perform these tasks on our behalf and
are obligated not to disclose or use it for any other purpose.
LINKS TO OTHER SITES
Our websites may contain links to other sites that are not operated by us. If you click on a third-party
link, you will be directed to that third party's site. We strongly advise you to review the Privacy Policy
of every site you visit.
We have no control over and assume no responsibility for the content, privacy policies or practices of
any third-party sites or services.
CHANGES TO THIS PRIVACY POLICY
This Privacy Policy may be updated from time to time. We will notify you of any changes by posting
the new Privacy Policy on this page.
We will let you know via email and/or a prominent notice on our website, prior to the change
becoming effective and update the “effective date” at the bottom of this Privacy Policy.
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.
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
consent
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
incomplete
The right to erasure (“right to be forgotten”) – you can request that your personal information
is deleted
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
Data Protection.
We encourage you to contact us, should you wish to practice any of your legal rights or you have any
questions about this Privacy Policy, by sending an email to NIPD Genetics’ Data Protection Officer at
dpo@nipd.com.
First Trimester
