Result card

  • CUR24: Which market authorization status (CE mark) has FIT in other countries, or international authorities?
English

Which market authorization status (CE mark) has FIT in other countries, or international authorities?

Authors: Mirjana Huic, Eleftheria Karampli, Silvia Florescu, Cipriana Mihaescu-Pintia

Internal reviewers: Laura Cacciani, Sophie Brunner, Esther Kraft

Data about market authorization status (CE mark) on FIT are provided by EUnetHTA Partners and Manufactures, and are presented below according answers from EUnetHTA Partners survey and EUnetHTA Manufacturers survey.

Data from EUnetHTA Partners Survey

Eight EUnetHTA Partner organisations provided information on market authorisation status of FIT (and/or FOBT) products and some of them provided information on their use in CRC screening programmes.

Croatia Product(s): Hemcare and Immocare-C, Care diagnostic Productions-und Vetriebsgssellschaft m.b.H, Austria Status: CE mark as in vitro diagnostic for occult blood testing in stool Use in CRC screening: not used in CRC screening programme (g-FOBT Hemognost test, BioGnost d.o.o., Zagreb is used in CRC screening)   Italy (Veneto Region) Product(s): OC SENSOR, EIKEN distributed by MEDICAL SYSTEM. Status: regular CE mark Use in CRC screening: Yes   Russia Product(s): FOB Gold Status: Russian registration certificate issued by Roszdravnadzor Use in CRC screening: Yes   Luxembourg FIT is currently not on the market   Lithuania Product(s): multiple registered FITs Status: Market authorization status here under Directive 98/79/EC of the European Parliament and the Council of European Union Use in CRC screening: information on the test specifically is used in CRC programme was not available   Spain Product(s): not specified Status: Approved Use in CRC screening: Yes   Slovenia Product(s): EIKEN, Japan Status: CE certificate Use in CRC screening: Yes   France Product(s): not specified Status: CE mark Use in CRC screening: used in CRC screening programmes in 7 regions

Data from Manufactures survey

 

Only one manufacturer provided information on their FITs (Sentinel Diagnostics). The following products have CE mark: FOB Gold® NG, FOB Gold® Tube Screen, SENTiFIT®- FOB Gold® latex, SENTiFIT®mini - FOB Gold® latex, SENTiFIT® pierceTube.

The FOB Gold® is distributed in all EU countries and in non-EU countries such as Turkey, Russia, and Czech Republic.

 

 

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Huic M et al. Result Card CUR24 In: Huic M et al. Health Problem and Current Use of the Technology In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=206

References