Terms & Conditions

General

This website (the “Website”) is controlled and operated by genEplanet and its subsidiaries. (“We”, “us”, “our” and “GenePlanet”). Please read the following terms and conditions (the “Terms and Conditions”) carefully as they set out the basis upon which we will grant you access to the Website and permit you to avail of the goods and services via the Website. By using our Website and services you agree to our Terms and Conditions and Privacy Policy, so please review all these documents carefully.

We may revise these Terms and Conditions at any time and for any reason.

You are solely responsible for ensuring your review of the most up to date version of the Terms & Conditions. By using the Website, or executing a Patient Consent Form, you accept and agree to the conditions contained in the most recent version of the Terms & Conditions and the Privacy Policy.

These Terms and Conditions shall be governed by the rules of a member state or other Applicable Law. The courts of the member state shall have exclusive jurisdiction over any claims or disputes arising in relation to, out of or in connection with these Terms and Conditions.

The Website provides direct to customer services only to persons who are legally competent to enter into a valid contract or have a written signature of a parent/legal guardian or as otherwise provided by the rules of a member state or other Applicable Law.

Description of the Website

This Website provides users with information relating to our goods and services.

It is intended for informational and educational purposes only. It does not constitute medical advice, nor is it a substitute for medical advice from a qualified healthcare provider. We do not practice medicine or provide medical services or advice. Prior to undergoing any testing or treatment, you should consult with a qualified healthcare professional regarding any risks, diagnoses, treatment, and/or any other potentially relevant healthcare issues.

Furthermore, healthcare information is constantly developing, and recommended standards and practices may change quickly. Therefore, it is always best to consult with and confirm any and all information obtained from the Website with your healthcare professional.

Please note that we do not administer NIFTY™ tests directly. NIFTY™ tests are administered by our local partners throughout Europe. You should consult with your qualified healthcare professional, and our local partner regarding whether the NIFTY™ test is right for you, and whether there is additional information available regarding the NIFTY™ test.

Users can find a list of local partners to choose from on our Website.

Basic information about the NIFTY™ test

NIFTY™ stands for Non-Invasive Fetal Trisomy test. It is a genetic screening test that pregnant women can take from the 10th week of their pregnancy.

The NIFTY™ test is a means of evaluating the risk of a baby having trisomy 21, trisomy 18 or trisomy 13. The term “trisomy” is used to describe the presence of an extra chromosome—three instead of the usual pair.

Specifically, trisomy 21 (Down syndrome) occurs when a baby is born with three copies of chromosome 21, trisomy 18 (Edwards syndrome) when a baby is born with three copies of chromosome 18, and trisomy 13 (Patau syndrome) when a baby is born with three copies of chromosome 13.

NIFTY™ also offers additional testing for other genetic disorders, depending on the chosen package.

NIFTY™ results and test limitations

Although the NIFTY™ test is highly accurate for identification of trisomies 21, 18 and 13, NIFTY™ is NOT a diagnostic test and may result in a ‘false positive’ or a ‘false negative’ result. This means that there is a possibility of the presence of chromosomal abnormalities despite the negative result of the test (the result is termed as “false negative”). The result of the test may be positive for certain chromosomal abnormalities, even if they are absent (the result is termed as “false positives”). In order to definitively confirm whether a condition exists, a diagnostic procedure, such as amniocentesis, is required. It is recommended that a HIGH RISK result is always confirmed by a diagnostic procedure. In some cases, follow up confirmatory testing based on these test results could uncover maternal chromosomal or genetic conditions.

The detection rate for aneuploidy of sexual chromosomes is 95%. The analysis can determine the gender of the fetus with 98% confidence.This information cannot be used to diagnose sexually transmitted diseases or diseases linked to sexual chromosomes.The test is also suitable for twin, egg donor and IVF pregnancies. The test evaluation in such cases is not yet possible, as the number of aneuploidies in such pregnancies is limited.

Potential causes for false positive or false negative results include but are not limited to maternal, fetal and/or placental mosaicism (mixture of chromosomally normal and abnormal cells in the pregnancy), balanced or unbalanced translocation, inversion, duplication, deletion, Robertson translocation, chromosomal aneuploidies or marker chromosome in mother and low fetal fraction. In case of a known maternal chromosomal abnormality, listed above, the sample is not appropriate for NIFTY™ testing. Sample can be accepted, if the mother has recovered from maternal metastatic cancer and there is no more tumor DNA presented in the blood.

The performance of the NIFTY™ analysis may be affected by therapy with low molecular weight heparin – LMWH.

Patients who have received a blood transfusion or stem cell therapy within one year prior to the testing date, are not eligible for the NIFTY™ test. If the mother had a transplant surgery, the sample is not appropriate for NIFTY™ testing. This applies to female patients only. If the father had a transplant surgery, a blood transfusion or stem cell therapy, there is no effect on the NIFTY™ test results.

NIFTY™ is also unable to accept samples in the cases of “vanishing twin syndrome” because of the possibility to unintentionally detect and analyse the twin’s DNA.

In case of the cellular immunotherapy where exogenous DNA is introduced, human serum albumin therapy, interferon therapy or immunoglobulin therapy, at least 4 weeks have to pass from the date of the last accepted therapy, before collecting the blood sample. NIFTY™ test is not suitable for pregnancies with more than 2 fetuses.

It is strongly advised that the NIFTY™ test is performed from 10 to 24 gestational weeks of pregnancy. If the patient decides to undergo testing after 24 gestational weeks, patient herself is responsible for any further courses of action, taken by the patient, following any or unwanted clinical outcomes from the NIFTY™ test. When submitting a sample, we recommend that you give precise information on the gestational age of the fetus.

NIFTY™ test results do not exclude the presence of all abnormalities of chromosomes and birth defects. With the test we also cannot detect all abnormalities, caused by chromosomal polyploidy (triploid, tetraploid, etc), chromosomal balanced translocation, inversion, ring, UPD, monogenic/polygenic disease, etc. This test cannot exclude the fetal mosaic chromosomal diseases.

In rare cases for specific analysed DNA sample it is not possible to obtain unambiguous information due to biological or technical reasons. This means, that the detected signal is of so low quality, that it is not possible to claim with 100% certainty, what the result is. When the obtained results were not conclusive due to various reasons, a resample is needed to increase the data set for further analysis. To repeat the test, we require an additional blood sample and a further 7 calendar days to deliver your results. There is no further charge for resampling.

In rare cases the results can be still inconclusive even after at least three independently performed tests. This can be due to different reasons, including inadequate fetal DNA or because the analysis failed our quality control. In this case we are unfortunately unable to obtain results and you will be provided with a full refund. Resampling is thus needed to increase the data set for further analysis. To repeat the test, we require an additional blood sample and a further 7 calendar days to deliver your results. There is no further charge for resampling.

Prior to testing, you should consult with a qualified healthcare provider as to whether any of the above listed conditions apply to you and/or advise your healthcare provider if you are already aware, that any of the above listed conditions apply to you. Test results should always be interpreted in the context of other clinical and family information.

You should never make decisions regarding your pregnancy without prior consultation with a qualified healthcare professional who is aware of the healthcare regulations relevant to your country of residence.

Use of the materials or trademarks on the Website

The materials on the Website belong to or are licensed to GenePlanet. The materials are protected by copyright. You may e-mail, download, or print copies of the materials on the Website, for your personal, non-commercial use only. However, when you e-mail, download, or print a copy of the materials on the Website for your personal use, you must also include all copyright and other notices that are in the materials, including the copyright notice on the bottom of the page.

The names of the products and services on the Website are owned by BGI, and these names are protected by trademark laws. All trademarks are the property of their respective owners.

There may be special rules for the use of materials provided on certain parts of the Website, which will be posted near the relevant materials.

Use of the materials or trademarks on the Website in a way that is not permitted by these Terms & Conditions, constitutes a violation of your agreement with us and may also be a violation of copyright, trademark, and other laws. In such cases, we automatically revoke your permission to use the Website. Title to the materials remains with us or with the authors of the materials contained on the Website. We reserve all rights not expressly granted to you.

Links to other Websites

We may provide links to websites on the Internet which are operated by third parties. Such links are provided for your convenience only. We make no representations whatsoever about any other websites which you may access through our website, or which may link to the Website. When you access any other website you understand that it is independent from us and that we have no control over the content or availability or privacy practices of that website.

Warranties and Disclaimers

WHILST ALL REASONABLE EFFORTS ARE MADE TO ENSURE THAT ANY INFORMATION, INCLUDING THE RESULTS, SUPPLIED BY US IS CORRECT, WE MAKE NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, IN RELATION TO THE TIMELINESS, ACCURACY OR COMPLETENESS OF SAID INFORMATION. YOU CAN NOT RELY SOLELY ON THE CONTENT OR INFORMATION RECEIVED FROM THE GENETIC ANALYSIS TO BASE YOUR DECISIONS ABOUT IMPORTANT PERSONAL AND MEDICAL MATTER ON IT. YOU SHOULD CONSULT AN APPROPRIATE PROFESSIONAL FOR ADVICE, WHICH WOULD BE SPECIFIC IN TERMS OF YOUR PARTICULAR SITUATION.

We make no representations, warranties or undertakings that the Website, or the server that makes it available, will be compatible with your equipment or free from defects, including but not limited to viruses or other harmful elements. We accept no liability for any infection by computer virus, bug, tampering, unauthorised access, intervention, alteration or use, fraud, theft, technical failure, error, omission, interruption, deletion, defect, delay, or any event or occurrence beyond our control, which corrupts or affects the administration, security, fairness and integrity or proper conduct of any aspect of the Website or your equipment.

We will make the necessary arrangements to ensure that the Website is fully operational at all times. However, due to the nature of interactive services and the internet generally, we cannot guarantee that the Website will be free from delays, interruptions or errors and access to the Website may be suspended (whether by us or due to external causes) temporarily and/or without notice. We will not be liable for any loss or damage arising from the Website not being available (whether for internal processing reasons or otherwise).

Except as expressly set out in these Terms and Conditions, all representations, warranties, terms and conditions whether express or implied in relation to this Website or the information contained therein are hereby excluded to the fullest extent permitted by law.

Please note that any limitations or exclusions set out in these terms and conditions of sale shall not operate to affect any statutory rights to which you are entitled to as a consumer.

Additional Terms

Terms additional to these Terms & Conditions and the Privacy Policy on the Website may apply when you access particular services or materials on certain areas on the Website, such as when you register to receive materials. Please read our Privacy Policy to learn how we protect and use information that we gather through the Website.

You agree to indemnify us and keep us indemnified in respect to all loss or damage suffered by it in connection to your use of the Website in breach of these Terms and Conditions and in respect of all claims or legal proceedings brought or threatened against it by any third party which arise in connection to your use of the Website in breach of these Terms and Conditions.

Printed terms and condition you will receive with your blood collection kit could differ from this ones on our Website, so please make sure to read them and agree with them as well.

These Terms & Conditions shall be governed in all respects by the rules of a member state or other Applicable Law.

These Terms & Conditions were last updated on 10/07/2019.

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