In the introduction we inform you that the laboratory of ALTAMEDICA, specialized in genetics with particular regard to prenatal procedures, has all the quality certifications foreseen and recommended:
UNI EN ISO 9001 Reg. 7662-A e UNI EN ISO 17025
As regards the CE-IVD marking, relating to in vitro diagnostic medical devices, it should be specified that “devices can only be marketed and/or used if they meet the requirements set out in the EU directive” (98/79/EC). This was then modified, for wording more specific, from 2007/47/CE. Recently, the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, relating to medical-diagnostic devices in vitro, progressively repeals Directive 98/79/CE (currently still in force) and the 2010/227/EU decision of the Commission and replaces them completely by 2023.
The tests used must therefore meet the requirements. Virtually all the tests available today declare a simple partial “declaration of conformity” that certifies only part of the process or even just the software.
FetalDNA is the only test on free fetal circulating DNA in maternal blood that has European CE-IVD certification both for the KIT and for the entire WORKFLOW as highlighted on the website of the Ministry of Health, Medical Devices Area.
In particular, in paragraph 4 of the technical file “GENERAL DESCRIPTION OF THE DEVICE” we find specified:
FetalDNA is a non-invasive prenatal in vitro screening test that involves analysis of free fetal DNA circulating in maternal blood. It uses the next generation of genome sequencing methods. Through this test it is possible to analyze cfNDA in pregnant women and the trisomies of chromosomes 13, 18 and 21, fetal sex, sex chromosome aneuploidies, aneuploidia of all other autosomes, assessment of structural alterations related to some microdeletion syndromes.
It is absolutely important for the doctor to prescribe the execution of this test as it is protected by complete documentation. By analogy it can be said that it is as if you prescribed a fully registered drug.
At present, pregnant women and attending doctors must verify that other NIPT tests have a similar and complete certification (in fact there are available on the market, tests without CE-IVD certification or in partial possession, such as software only).
Prescribing one of these diagnostic tests is, abstractly, equivalent to prescribing a drug that has a partial registration or does not have it at all.