{"id":9615,"date":"2017-11-09T18:07:01","date_gmt":"2017-11-09T18:07:01","guid":{"rendered":"http:\/\/www.fetaldna.it\/certificazioni\/"},"modified":"2022-03-06T20:25:09","modified_gmt":"2022-03-06T20:25:09","slug":"certification","status":"publish","type":"page","link":"https:\/\/www.fetaldna.it\/en\/certification\/","title":{"rendered":"Certification and Patents"},"content":{"rendered":"

[vc_row full_width=”stretch_row” softing_row_overlay_type=”custom” softing_bg_attachment=”fixed” softing_lg_bgpos=”center” css=”.vc_custom_1641315874674{padding-top: 120px !important;padding-bottom: 120px !important;background-image: url(https:\/\/www.fetaldna.it\/wp-content\/uploads\/2021\/12\/Sfondo_Altamedica_grigio-1.png?id=13217) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” softing_row_overlayclr=”rgba(242,72,62,0.4)”][vc_column][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” softing_row_prepad=”ptb-30″][vc_column][vc_custom_heading text=”CERTIFICATION & PATENTS” font_container=”tag:h2|text_align:center” use_theme_fonts=”yes”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” full_height=”yes”][vc_column][vc_column_text]<\/p>\n

The ALTAMEDICA laboratory, specialized in Genetics with a deep focus to prenatal medicine, has all the required and recommended quality certifications:<\/h4>\n

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CE-IVD label
\nNon-invasive Prenatal Test
\nFetalDNA Altamedica<\/p>\n

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Quality System compliant
\nwith UNI EN ISO 9001:2015
\nReg. 7662-A<\/p>\n

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Ministry of Economic Development
\nPatents nr 102018000005623 and
\nN. 102018000004527<\/p>\n

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FetalDNA is the only prenatal test<\/strong> on fetal DNA circulating on maternal blood that has the European CE-IVD certification for both the KIT<\/strong>and the entire WORKFLOW<\/strong>, as highlighted on the website of the Ministry of Health – Medical Devices Area.<\/h4>\n

Here below you can find point 4 of the technical file “GENERAL DESCRIPTION OF THE DEVICE\u201d:<\/h4>\n

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.<\/em>
\nBy 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.<\/em><\/p><\/blockquote>\n

We can say that all tests available today declare a simple partial \u201cdeclaration of conformity<\/i>\u201d 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,<\/strong>describing all the procedures (from the sample processing to the validation of results by using an exclusive software).<\/h4>\n

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<\/i>” (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, progressively<\/i>repeals Directive 98\/79 \/ EC (still in force today) and decision 2010 \/ 227 \/ EU of the Commission and it will completely replace them by 2023.<\/h4>\n

[\/vc_column_text][vc_separator color=”custom” border_width=”2″ accent_color=”#f2483e” css=”.vc_custom_1641314343647{padding-top: 3% !important;}”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” full_height=”yes”][vc_column][vc_custom_heading text=”PATENTS” font_container=”tag:h2|text_align:center” use_theme_fonts=”yes” css=”.vc_custom_1641314429440{padding-top: 3% !important;}”][vc_column_text]<\/p>\n

ALTAMEDICA has 2 CE-IVD certifications for its FetalDNA NIPT:<\/h4>\n

– KIT FETALDNA<\/strong><\/h4>\n

– FETALDNA WORKFLOW NIPT CE-IVD FOR ALL AUTOSOMAL AND SEXUAL ANEUPLOIDIES, MICRODELETIONS AND MONOGENIC DISEASES<\/strong>The 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<\/h4>\n

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\"Finding<\/a><\/p>\n

[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

[vc_row full_width=”stretch_row” softing_row_overlay_type=”custom” softing_bg_attachment=”fixed” softing_lg_bgpos=”center” css=”.vc_custom_1641315874674{padding-top: 120px !important;padding-bottom: 120px !important;background-image: url(https:\/\/www.fetaldna.it\/wp-content\/uploads\/2021\/12\/Sfondo_Altamedica_grigio-1.png?id=13217) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}” softing_row_overlayclr=”rgba(242,72,62,0.4)”][vc_column][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” softing_row_prepad=”ptb-30″][vc_column][vc_custom_heading text=”CERTIFICATION & PATENTS” font_container=”tag:h2|text_align:center” use_theme_fonts=”yes”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” full_height=”yes”][vc_column][vc_column_text] The ALTAMEDICA laboratory, specialized in Genetics with a deep focus to prenatal medicine, has all the required and recommended quality certifications: [\/vc_column_text][vc_row_inner softing_row_prepad=”ptb-20″][vc_column_inner width=”1\/3″][vc_single_image image=”13066″ img_size=”large” alignment=”center”][vc_column_text]…<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"custom-page.php","meta":{"footnotes":""},"class_list":["post-9615","page","type-page","status-publish","hentry"," c-blog-1-item nt-post-class"],"yoast_head":"\nCertifications FetalDNA test - FetalDNA - Altamedica Rome<\/title>\n<meta name=\"description\" content=\"Quality Certifications for FetalDNA test. 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