Such states are in a better position to consider the cost-effectiveness and reliability of the new tests and to either limit or extend them to the detection of particular fetal pathologies in certain categories of pregnant women. According to Löwy, the variability in the implementation of NIPT across the world is because of the existent state-sponsored testing programs for trisomy 21. However, in some other countries, the test is paid for by private or public insurers, who may choose to restrict its use to the detection of certain pathologies among categories of pregnant women at higher risk of fetal anomalies. ![]() In some countries, such as Brazil, extended versions of this test are available only at private health facilities, thereby limiting its use to women who can afford it out of their own pockets. Some of these chromosomal alterations lead to pathologies with varying seriousness. Based on the versions, these tests can detect a variable number of more or less rare anomalies (only trisomy 21, or also trisomy 13 and 18, or also rare trisomies, or even chromosomal microdeletions, etc.) with varying degrees of reliability. The implementation of NIPT differs from country to country. The latter, requires invasive sampling, such as amniocentesis or trophoblast biopsy, thereby carrying a small risk of miscarriage. Because of the lower false-positive results of NIPT, it offers the advantage of reducing the need for a diagnostic test. Positive results must be confirmed by a diagnostic test, such as the fetal karyotype. This test involves the analysis of cell-free fetal DNA circulating in pregnant women’s blood and provides reliable (fewer false positives and false negatives) results earlier in the pregnancy. However, previous tests for testing and diagnosing fetal anomalies have not been patented and are less expensive.ĭespite its high price, NIPT has been a commercial success because of its several advantages over conventional testing for trisomy 21, such as serum markers 1 and ultrasound scans, or a combination of both. These companies have applied for patents in various countries. ![]() Since its launch in 2011, NIPT has been commercially available in many countries, which is mainly due to the driving force of biotechnology companies manufacturing these tests. Non-invasive prenatal testing (NIPT) is a newly developed genetic test designed to detect chromosomal anomalies in fetuses. ![]() Non-invasive prenatal testing (NIPT) regulation prenatal screening informed consent France ethics reproductive autonomy 1. The analysis reveals that the regulations, consistent with that applied to other prenatal screening techniques, fail to take proper account of the following problems posed by NIPT: the continuing increase in the number of abnormalities detected in fetuses, the context of mounting pressure from the manufacturers, and the challenges involved in providing pregnant women with quality information that preserves their reproductive autonomy. In addition, this article evaluates the effectiveness of the regulatory framework in addressing the ethical and social issues raised by this technique from a legal and sociological perspective. This article examines the regulation of the screening of fetal abnormalities in France before and after the implementation of the new technique of non-invasive prenatal testing (NIPT) in 2013. This is an open access article distributed under the conditions of the Creative Commons by Attribution License, which permits unrestricted use, distribution, and reproduction in any medium or format, provided the original work is correctly cited. The Regulation of Non-Invasive Prenatal Testing (NIPT) in France: Continuity and Changes in the Development of Prenatal Testing. Recommended citation: Vassy C, Brunet L, Noiville C. Received: Septem| Accepted: Febru| Published: February 25, 2022 ![]() Special Issue: Policy Issues in Prenatal and Neonatal Testing, Counseling, and Decision-Making Institut des Sciences Juridiques et Philosophiques de La Sorbonne, Université Paris 1 CNRS, UMR 8103, 1 rue de la glacière, 75013 Paris, FranceĪcademic Editors: Diane B. Université Sorbonne Paris Nord, IRIS, EHESS, CNRS, UMR 8156, Inserm U997, 74 rue Marcel Cachin, 93 000 Bobigny, France Carine Vassy 1,*, Laurence Brunet 2, Christine Noiville 2
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