During pregnancy, fetal DNA travels from the placenta to the mother’s blood stream and circulates along with her own DNA. VERACITY is a new generation non-invasive prenatal test that accurately measures the fetal cell-free DNA in the maternal blood to detect the presence of fetal aneuploidies and microdeletions. VERACITY has been validated for both single and twin pregnancies as well as pregnancies conceived through in-vitro fertilization (IVF).

The doctor or lab collects a blood sample from the mother’s arm and sends it to our state-of-the-art laboratories for analysis. At the laboratory, cell-free DNA is isolated from the mother’s blood and analyzed using our proprietary, new generation analytic and bioinformatic technology. Results are provided to your doctor in a few working days.

NEW GENERATION NON-INVASIVE PRENATAL TEST (NIPT)

  • Can be done from 10 weeks of pregnancy
  • Validated for singleton and twin pregnancies
  • Applicable also for IVF pregnancies
  • Preferred for its accuracy, robustness and affordability
What is Veracity?

PROPRIETARY TARGETED METHODOLOGY

VERACITY is a new generation non-invasive prenatal test (NIPT) for the detection of fetal chromosomal aneuploidies and microdeletions. It uses proprietary technology based on cutting-edge research and development in molecular genetics and bioinformatics. It was specifically designed by NIPD Genetics to avoid technical limitations and shortcomings of other NIPT.

VERACITY has been developed by an outstanding scientific team with over 25 years of experience in the field of prenatal diagnosis, molecular medicine, genomics, transcriptomics, methylomics and bioinformatics.

VERACITY uses novel Targeted Enrichment Technology that enables with unparalleled accuracy chromosomal aneuploidy detection as well as fetal fraction measurement. Targeted regions on selected chromosomes and chromosomal regions are captured, enriched and analysed for the detection of aneuploidies and microdeletions using our proprietary genomic and bioinformatic technologies.

Veracity
Conventional
Prenatal Tests
Cell-free DNA extracted from maternal plasma
Screening combines... Biochemical Screening Results, Ultrasound Findings and Other Parameters
Highly Accurate >99% detection rate
Low Accuracy Risk score has 80–95% detection rate
Safe No risk of fetal miscarriage
Risk for miscarriage through amniocentesis or CVS (0.5%)
Fast Can be done from 10 weeks Results in 4-7 working days
Can be done after 12 weeks of pregnancy
First Trimester
Screening
Invasive
Prenatal Diagnosis
Type of Test
Screening that measures likelihood of trisomies 21, 18 and 13, and X, Y aneuploidies, and four microdeletions. Screening test that measures likelihood of trisomies 21, 18, and 13. Diagnostic test to determine chromosome abnormalities.
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.

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.
Accuracy
Higher than 99% for trisomy 21, 18 and 13 and several other anomalies. 80-95% for trisomy 21, 18 and 13. Higher than 99% for trisomy 21, 18 and 13 and several other anomalies.

UNIQUE FEATURES OF VERACITY

TARGETED GENOMIC ANALYSIS

VERACITY 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 VERACITY.

HIGH READ DEPTH

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

FETAL FRACTION MEASUREMENT

A proprietary bioinformatics software accurately calculates fetal fraction. Accurate fetal fraction measurement increases the robustness and reliability of VERACITY.

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 VERACITY TEST FOR?

AUTOSOMAL ANEUPLOIDIES

  • Down syndrome (Trisomy 21)
  • Edwards syndrome (Trisomy 18)
  • Patau syndrome (Trisomy 13)

SEX CHROMOSOME ANEUPLOIDIES

  • Turner syndrome (Monosomy X)
  • Triple X syndrome (Trisomy X)
  • Klinefelter syndrome (XXY)
  • Jacobs syndrome (XYY)
  • XXYY syndrome

MICRODELETIONS

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

CLINICAL PERFORMANCE

AUTOSOMAL TRISOMIES

KARYOTYPE Number Follow-Up Correct SPECIFICITY NPV
Normal 10280 10280 10280 99.98% (99.93-99.998%) 100% (99.96 – 100%)
KARYOTYPE Number Follow-Up Correct SENSITIVITY PPV
Trisomy 21 126 44 44 100% (92 – 100%) 100% (92 – 100%)
Trisomy 18 24 10 10 100% (69 – 100%) 100% (69 – 100%)
Trisomy 13 16 7 5 100% (48 – 100%) 71% (29 – 96%)

SEX CHROMOSOME ANEUPLOIDIES

KARYOTYPE Number Follow-Up Correct SPECIFICITY NPV
Normal 6200 6200 6200 99.95% (99.86 – 99.99%) 100% (99.94 – 100%)
KARYOTYPE Number Follow-Up Correct SENSITIVITY PPV
45, X 16 7 4 100% (40-100%) 57% (18-90%)
47, XXX 6 2 2 - -
47, XXY 10 4 4 - -
47, XYY 3 0 - - -
48, XXYY 1 1 1 - -
  • Kypri et al. Non-invasive prenatal testing of fetal chromosomal aneuploidies: validation and clinical performance of the veracity test. Molecular Cytogenetics, 2019; 12:34

VALIDATION STUDIES

  • Development and Validation Study 1
    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 Study 2
    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 Study 3
    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 under review.
  3. Manuscript under review.

Other Products

NIPD Genetics - Privacy Policy

General Statement

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:

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:

Email address: dpo@nipd.com

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.

This Privacy Policy applies to NIPD Genetics facilities, its websites www.nipd.com, www.nipdlabs.com, www.nipdlabs.com.cy and their subdomains, that link to this privacy pol icy.

PERSONAL INFORMATION COLLECTION AND PROCESSING

We collect and process several types of personal information from and about users of our websites and of our products and services, including:

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:

  1. 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.
  2. 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.
  3. To process and respond to complaints. The legal basis for processing is to meet a legal obligation.
  4. 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:

  1. 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.
  2. 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.
  3. 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:

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:

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.

Effective date: 18/06/2021

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