In premise, it is informed that the ALTAMEDICA laboratory , specialized in prenatal genetics, 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 devices, it should be specified that it is reads as follows: “the devices may be placed on the market and/or put into service only if they meet the requirements standards based on the Community Directive” (98/79/EC). This was amended, for formal clarifications, from 2007/47/EC. Recently, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 concerning in vitro diagnostic medical devices, progressively repeals Directive 98/79/EC (which is still in force today) and decision 2010/227/EU of Commission and replace them completely by 2023.
The tests used must therefore meet the prescribed requirements. Practically 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 free fetal DNA test circulating on maternal blood that has the European CE-IVD certification on the whole workflow as stated in the ministerial document filed at the Ministry of Health in point 04 – GENERAL DESCRIPTION OF THE DEVICE of the technical file.
FetalDNA is a non-invasive screening test in prenatal in vitro that involves the analysis of free fetal DNA circulating on maternal blood. It uses the latest generation genomic sequencing methodologies – innovative-NIPT (iNIPTTM).
Using this test it is possible to analyze the cfNDA in pregnant women and trisomies of chromosomes 13, 18 and 21, fetal sex, aneuploidy of the sex chromosomes, aneuploidy of all the other autosomes, evaluation of structural alterations related to some microdelection 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 a completely registered drug was prescribed.
At present all the other tests available on the market or are without CE-IVD certification or are only partially available (for example, only software).
Prescribing one of these diagnostic tests is tantamount to prescribing a drug that has a partial registration or does not possess it at all.