Intertek support QuantuMDx Group Limited with stability testing, for SARS-CoV-2 RT-PCR Detection assay
June 23, 2020
Manchester, UK: Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce that it is supporting QuantuMDx Group Limited through verification of stability for its new rapid and sensitive SARS-CoV-2 RT-PCR Detection assay.
QuantuMDx’ assay has now been CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within the European Union.
The stability of an in vitro diagnostic (IVD) assay is critical to its reliable performance over a defined period. It is a regulatory requirement for an IVD manufacturer to demonstrate sound evidence to support all claims made regarding the stability of an IVD. The Intertek pharmaceutical services team, based at their GMP compliant laboratory in Manchester, UK, are conducting real-time and accelerated stability studies on QuantuMDx’ proprietary SARS-CoV-2 detection RT-PCR assay to confirm the ability of the assay to maintain performance characteristics over a defined time interval. Inherent to this study, Intertek’s scientists will perform reverse transcription polymerase chain reaction (RT-PCR) tests.
QuantuMDx’s proprietary SARS-CoV-2 detection RT-PCR assay kit has been designed with the most up-to-date sequence information to ensure 100% coverage of all known SARS-CoV-2 sequences. The assay can run on multiple open PCR platforms, for both high and low throughput. In addition, the assay reagents are lyophilised in a single vial, enabling convenient shipping and a longer shelf life.
Graham Ritchie, Executive Vice President - Europe, Intertek, “We are proud to be supporting QuantuMDx and their innovative diagnostic technology. Our team, located in Manchester, UK, work to the highest standards of quality including Good Manufacturing Practice, and is committed to supporting clients to develop quality, innovative diagnostic, therapeutic or vaccine products which are vital to progress the fight against COVID-19.”
Jennifer Hannant, Manufacturing Science & Technology Team Lead at QuantuMDx said: “To support national and international efforts to tackle COVID-19 and expedite our product development, we needed to collaborate with independent contract research organisations, like Intertek, to ensure that our technology adheres to the highest levels of quality compliance. We’re delighted to be working with colleagues at Intertek and look forward to an ongoing partnership.”
Intertek provides pharmaceutical development and manufacturing support services spanning analysis, bioanalysis, formulation development, regulatory consultancy, auditing and supply chain management solutions from its network of offices and regulatory laboratories including Manchester, (UK), Melbourn, near Cambridge (UK), Basel (Switzerland), San Diego (California, USA), Whitehouse, (New Jersey, USA) and Melbourne, (Australia).
In Vitro Diagnostic Device Support Services
Pharmaceutical Stability Studies and ICH Storage
Intertek Pharmaceutical Services Manchester
For Media Information
Marketing Manager, Intertek Pharmaceutical Services
T: +44 161 721 1476
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Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 46,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.
QuantuMDx Group is an ambitious company with a global vision of empowering the world to control and eradicate disease by making transformative, quality point-of-care diagnostic technologies universally accessible. QuantuMDx has operations and strategic partnerships in the United States, Asia, Australasia, Europe and Africa – keeping it at the forefront of molecular diagnostics.
For media enquiries:
Marketing Communications Manager, QuantuMDx
T: +44 870 803 1234