Non-Invasive Prenatal Screening Methods

Throughout pregnancy there is a wish that is universally shared by all prospective parents –to learn that their baby is healthy. Along with the other tests and medical appointments to evaluate the pregnancy and the fetus’s health, growth and development, non-invasive prenatal testing (NIPT) has become a standard part of prenatal care in the past few years. NIPT is a blood test taken by a pregnant woman to check for genetic conditions of the fetus before birth. Despite its recent introduction, NIPT has been widely adopted by the medical community and is routinely requested by prospective parents in addition to traditional screening. Why was there a need for yet another screening test, and how does NIPT differ from the other screening tests that are already established in clinical practice?

To start with, let’s examine the term ‘screening tests’. A screening test lets the patient know if there is an increased risk of having the tested condition, and the results are provided in terms of possibilities or risk scores. Whereas, a diagnostic test —such as amniocentesis– provides a verdict on whether or not the patient has the condition tested. The results are definite; a diagnosis is made. Why then opt for a screening test instead of a diagnostic test? In the majority of cases, a screening test can be performed earlier during the pregnancy and is safer than a diagnostic test. As such, it is the ‘first step’ of the diagnostic journey, as only patients who are reported as ‘high risk’ on their screening tests would have to undergo invasive diagnostic tests.

The 1st and 2nd trimester screening tests currently in place include biochemical screening and ultrasound exams. These take place during weeks 11-13 of gestation and in weeks 15-20, and are the routinely established clinical tests to assess certain developmental milestones of the baby. The physician takes into account the fetus’s measurements, the pregnant woman’s hormonal levels and a set of variables such as age, weight or smoking factors to determine if there is an increased risk of the baby having one or more of the conditions tested. If the risk estimated is high, further testing in the form of diagnostic procedures –Chorionic Villus Sampling (CVS) or Amniocentesis– will be recommended by the physician to provide a definite diagnosis. Both of these are characterized as ‘invasive’, as they require inserting a needle through the abdomen into the placenta or the amniotic fluid to collect a sample. Critically, both carry a small risk of pregnancy loss so a lot of prospective parents struggle with the choice to continue with further testing.

The need for NIPT arises because the 1st and 2nd trimester traditional screening tests rely on statistical formulas that are not patient-specific. Consequently, a large number of patients end up having to unnecessarily undergo highly stressful and potentially dangerous procedures. Evidently, the basic principle of the ‘screening test’– to be able to test and accurately refer ‘high-risk’ patients for further testing – is not fully met by traditional measures. This leaves a crucial need for a more precise and sensitive screening method to be introduced in clinical practice to increase detection of genetic conditions. This need is addressed by the introduction of NIPTs.

With NIPT, genetic material (DNA) from the baby’s placenta, known as cell-free fetal DNA (cffDNA) can be extracted from the mother’s blood and examined. NIPT involves the use of specialized equipment and software, which analyze the baby’s DNA safely, accurately and affordably as early as the 10th week of pregnancy. Results are sent to the patients’ healthcare providers within a few working days. Thus, physicians and parents-to-be can learn earlier in the pregnancy if there is an increased possibility of the baby having a genetic disorder. If NIPT results are positive, the patient’s physician will recommend the next steps, taking other clinical findings also into consideration.

The role between traditional screening tests already established in clinical practice and NIPT is synergistic rather than antagonistic. Routine screening tests are routine for a reason –they work. However, the accuracy and sensitivity of traditional prenatal screening when it comes to detecting chromosomal abnormalities can be improved. NIPTs offer more accuracy and have the capacity to test for more conditions in this area, giving patients the information they need to know about the health of their baby. In traditional prenatal screening, age is the biggest factor when it comes to calculating a patient’s risk –the higher the patient’s age, the higher the risk is that the baby has a genetic condition. This reasoning is true for Down syndrome, one of the most common genetic disorders. However, age isn’t the only variable and a lot of younger pregnant women tend to go undiagnosed if they only undergo traditional prenatal screening. Moreover, there are a lot of conditions that are independent of maternal age that NIPT can screen for, such as microdeletions or single gene diseases. These conditions occur randomly and currently cannot be screened by traditional tests. It is therefore critical beneficial for all pregnant women to have an NIPT as it provides them with a lot of information they would not otherwise have had, had they only undergone standard prenatal screening.

NIPT is not just another screening test. NIPT gives parents the chance to know their baby without any risk to the pregnancy. NIPTs very high level of accuracy greatly improves prenatal screening. This means that even though pregnant women will still be referred for invasive procedures, those who do not need it will avoid the unnecessary risk exposure. The most important benefit NIPT offers to prospective parents is reassurance and time. Time that allows them to think, reflect and evaluate their choices; to gather all necessary information, decide on their future and manage their clinical care based on informed decisions.

Medical results should always be discussed with your healthcare providers.

For more information on what conditions our NIPT tests, VERACITY and VERAgene test for, please visit the tabs ‘VERACITY’ and ‘VERAgene’ on our website at www.nipd.com.


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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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