The ALTAMEDICA laboratory, specialized in Genetics with a deep focus to prenatal medicine, has all the required and recommended quality certifications:

FetalDNA is the only prenatal test on fetal DNA circulating on maternal blood that has the European CE-IVD certification for both the KITand the entire WORKFLOW, as highlighted on the website of the Ministry of Health – Medical Devices Area.

Here below you can find point 4 of the technical file “GENERAL DESCRIPTION OF THE DEVICE”:

FetalDNA is a non-invasive prenatal in vitro screening based on the analysis of fetal DNA circulating on maternal blood. It uses state-of-the-art genomic sequencing methodologies.
By using this test, it is possible to analyze the cfNDA in pregnant women and the trisomies of chromosomes 13, 18 and 21, fetal sex, aneuploidy of the sex chromosomes, aneuploidy of all the other autosomes, evaluation of the structural alterations related to some microdeletion syndromes.

We can say that all tests available today declare a simple partial “declaration of conformity” which certifies only part of the process or even only the software. It is absolutely important for the doctor to prescribe the execution of this test as it is protected by complete documentation,describing all the procedures (from the sample processing to the validation of results by using an exclusive software).

As regards the CE-IVD label for in vitro diagnostic devices, it clearly states that “the devices can be placed on the market and / or put into service only if they meet the requirements set out in the Community directive” (98 / 79 / EC). This was then modified, for formal clarifications, by 2007/47 / EC. Recently, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, relating to in vitro diagnostic medical devices, progressivelyrepeals Directive 98/79 / EC (still in force today) and decision 2010 / 227 / EU of the Commission and it will completely replace them by 2023.

ALTAMEDICA has 2 CE-IVD certifications for its FetalDNA NIPT:

– KIT FETALDNA

– FETALDNA WORKFLOW NIPT CE-IVD FOR ALL AUTOSOMAL AND SEXUAL ANEUPLOIDIES, MICRODELETIONS AND MONOGENIC DISEASESThe second certification includes a detailed documentation shared with Ministry of Health, describing all the procedure (from the sample processing to the validation of results by using an exclusive software