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Die neuen Tests von Roche für das Management von Infektionen mit dem Hepatitis-C-Virus erhalten CE-Kennzeichnung


News provided by

Roche

Jan 05, 2012, 01:00 ET

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PLEASANTON, Kalifornien, January 5, 2012 /PRNewswire/ --

- Die Tests verändern das Management von Hepatitis-C-Erkrankungen und der Patienten

Roche (SIX: RO, ROG; OTCQX: RHHBY) gab heute bekannt, dass seine neuesten, technisch führenden qualitativen und quantitativen Hepatitis-C-Virus (HCV) Tests die CE-Kennzeichnung erhalten haben. Die Tests weisen HCV-RNA nach, einen wichtigen Marker beim Management von Hepatitis-C-Infektionen. Im neuen Zeitalter der antiviralen HCV-Therapien spielen empfindliche Nachweismethoden und die Messung von HCV-RNA eine wichtige Rolle bei der Festlegung der Behandlungsdauer und der Vorhersage des Behandlungserfolgs.

"Die beiden Tests bieten eine ganzheitliche Lösung für das Management von Hepatitis-C-Infektionen: Von der Bestätigung einer Hepatitis-C-Infektion bis zur Vorhersage und Beurteilung des Behandlungserfolgs", erklärt Dr. Paul Brown, Leiter von Roche Molecular Diagnostics. "In Anbetracht des sich bei Hepatitis C sehr schnell verändernden Behandlungsumfelds sind wir stolz, dass wir zwei medizinisch relevante Tests auf einer voll automatisierten Plattform anbieten können. Dies gibt Klinikern ein Werkzeug für das effektive Patientenmanagement an die Hand und Laboratorien die erforderliche Automatisierung und Flexibilität für eine effektive Optimierung des Arbeitsablaufes."

Der COBAS AmpliPrep/COBAS TaqMan HCV qualitative Test, v2.0(1) dient dem Nachweis von HCV-Antikörpern in Proben und der COBAS AmpliPrep/COBAS TaqMan HCV quantitative Test, v2.0 der Überwachung der Viruslast sowie der Vorhersage des virologischen Ansprechens auf die Antivirustherapie. Beide Tests entsprechen dem Standard der Weltgesundheitsorganisation (WHO) und haben eine Nachweisgrenze und eine untere Bestimmungsgrenze von 15 IU/mL. Diese Merkmale machen sie zu medizinisch relevanten Diagnosewerkzeugen beim Management von Hepatitis-C-Infektionen.

Auf dem gleichen, voll automatisierten COBAS AmpliPrep/COBAS TaqMan System bietet Roche auch COBAS TaqMan HIV-1 v2.0, HBV v2.0 und CMV(2) Tests.

Über Hepatitis C

Nach Angaben der Weltgesundheitsorganisation sind weltweit ~200 Millionen Menschen vom Hepatitis-C-Virus betroffen, etwa 170 Millionen Menschen sind chronisch mit dem Hepatitis-C-Virus infiziert und die meisten wissen nicht, dass sie infiziert sind. Etwa 65 - 75 % entwickeln chronische HCV, die zu Zirrhose, Leberversagen und hepatozellulärem Karzinom führen kann.

Über Roche

Roche mit Hauptsitz in Basel, Schweiz, ein führendes, forschungsorientiertes Unternehmen, ist auf die beiden Geschäfte Pharma und Diagnostics spezialisiert. Als weltweit größtes Biotech-Unternehmen entwickelt Roche klinisch differenzierte Medikamente für die Onkologie, Virologie, Entzündungs- und Stoffwechselkrankheiten und Erkrankungen des ZNS. Roche ist auch der weltweit bedeutendste Anbieter von In-vitro-Diagnostik und gewebebasierten Krebstests und ein Pionier im Diabetesmanagement. Medikamente und Diagnostika, welche die Gesundheit, die Lebensqualität und die Überlebenschancen von Patienten entscheidend verbessern, sind das strategische Ziel der personalisierten Medizin von Roche. 2010 beschäftigte Roche weltweit über 80.000 Mitarbeitende und investierte fast 9 Milliarden Schweizer Franken in F&E. Der Konzern erzielte einen Umsatz von 47,5 Milliarden Schweizer Franken. Genentech, USA, gehört vollständig zur Roche-Gruppe. An Chugai Pharmaceutical, Japan, hält Roche die Mehrheitsbeteiligung. Weitere Informationen erhalten Sie unter: http://www.roche.com.

Bei weiteren Fragen bitten wir Sie, Corporate Communications unter der Telefonnummer +1-925-730-8346 zu kontaktieren.

Alle in dieser Mitteilung erwähnten Markennamen sind gesetzlich geschützt.

(1) Die COBAS AmpliPrep/COBAS TaqMan HCV qualitativen und quantitativen Tests, v2.0 sind in den Vereinigten Staaten nicht erhältlich
(2) Der COBAS AmpliPrep/COBAS TaqMan CMV Test ist in den Vereinigten Staaten nicht erhältlich

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