CE-IVD-gecertificeerd, IVDR-compatibel qPCR-systeem ondersteunt nieuwe moleculaire diagnostische productie- en testworkflows

CARLSBAD, Californië–(BUSINESS WIRE)– Om fabrikanten van moleculaire diagnostiek en klinische testlaboratoria te helpen zich aan te passen aan de hogere standaard in vitro diagnostische vereisten (IVDR) die nu van kracht zijn in de Europese Unie, biedt Thermo Fisher Scientific een IVDR-versie van de Applied Biosystems QuantStudio 5 Dx Real-Time PCR-systeem wereldwijd. Het innovatieve qPCR-systeem vereenvoudigt moleculaire diagnostische workflows voor infectieziekten en oncologie.

Fabrikanten van moleculaire diagnostische kits en klinische testlaboratoria die hun eigen tests ontwikkelen, hebben open qPCR-platforms nodig die voldoen aan de IVDR-vereisten. Het IVDR-conforme QuantStudio 5 Dx-systeem stelt fabrikanten van moleculaire diagnostiek in staat om nieuwe IVDR-conforme tests te ontwikkelen onder de nieuwe regelgeving. Het systeem zal klinische laboratoria die diagnostische tests uitvoeren ook helpen om over te schakelen naar IVDR qPCR-tests.

Thermo Fisher Scientific Updates Applied Biosystems QuantStudio 5 Dx Real-Time PCR System to Comply with IVDR Regulations

CE-IVD certified, IVDR-compliant qPCR system supports new molecular diagnostic manufacturing and testing workflows

CARLSBAD, Calif.–(BUSINESS WIRE)– To help molecular diagnostic manufacturers and clinical testing laboratories adapt to higher-standard In Vitro Diagnostic Requirements (IVDR) now in effect in the European Union, Thermo Fisher Scientific is offering an IVDR version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System globally. The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology.

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The IVDR-compliant QuantStudio 5 Dx System simplifies molecular diagnostic workflows for infectious disease and oncology. (Photo: Business Wire)

Molecular diagnostic kit manufacturers and clinical testing labs that develop their own assays need open qPCR platforms that meet IVDR requirements. The IVDR-compliant QuantStudio 5 Dx System will enable molecular diagnostic manufacturers to develop new IVDR-compliant tests under the new regulations. The system will also help clinical labs running diagnostic tests switch to IVDR qPCR testing.

“Molecular diagnostic manufacturers and laboratories that lack appropriately validated and CE-labelled instruments and tests may face delays under the new IVDR regulations,” said Marty Murawski, vice president, regulatory and quality assurance, at Thermo Fisher Scientific. “We are committed to helping our customers maintain high patient safety standards, meet new requirements, and obtain proper accreditation to remain competitive in today’s market. By making the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System IVDR-compliant, we can now provide a high-performance, reliable qPCR system to support new testing workflows.”

Among the system’s updates, the multi-mode software is now IVDR compliant, providing dual functionality for running diagnostic tests and developing new assays in today’s regulatory environment. The qPCR system comes with an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. In addition, a security, auditing, e-signature module provides secure operation.

The updated QuantStudio 5 Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is also listed with the U.S. Food and Drug Administration (FDA).

For more information, please visit www.thermofisher.com/quantstudio5dx.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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Contacts

Media:

Mauricio Minotta

Phone: 760-805-5266

Email: mauricio.minotta@thermofisher.com

Jen Heady

Phone: 413-237-5141

Email: jheady@greenough.biz