IVD Performance Evaluation

IVD Performance Evaluation

Before an IVD test can be CE marked and placed on the market in the UK and European Union, a formal Clinical Performance Evaluation must be performed in order to demonstrate test performance meets the claims made by the manufacturer.

NewGene has provided laboratory services for Clinical Performance Evaluation studies of IVD devices, utilising established clinical systems for reference and concordance analyses. The company works closely with the Newcastle University MRC Molecular Pathology Node and Diagnostic Evaluation Co-operative to facilitate access to clinically relevant sample materials and independent analytical support in such studies.

Case study: Biocartis Idylla NRAS – BRAF Clinical Performance Evaluation

Biocartis N.V. is an innovative molecular diagnostics company, which aims to provide direct access to personalized medicine for patients worldwide by developing fully integrated and broadly applicable molecular diagnostics which can be used in a wide variety of healthcare settings.

Their first device to be launched, the IdyllaTM, is a fully automated, real-time Polymerase Chain Reaction (PCR) based molecular diagnostics system. It utilises a self-contained disposable cartridge system to detect and quantify multiple DNA or RNA-based biomarkers in a wide variety of patient sample types.

As part of development of a new CE-IVD marked test for the system, capable of detecting specific mutations in the NRAS and BRAF genes, Biocartis utilised testing services provided by NewGene.

Two-hundred and forty-two formalin fixed paraffin-embedded (FFPE) human malignant colorectal cancer (CRC) tissue samples were sourced and tested with both the investigational IdyllaTM NRAS-BRAF mutation test and a reference test performed using the Agena Bioscience MassARRAYTM system.

The overall concordance between the Idylla NRAS-BRAF mutation test and the MassARRAY comparator reference test result was 241/242 (99.59%) for NRAS and 242/242 (100%) for BRAF. Complete details of the study are published in Johnston L, Power M, Sloan P, et al. J Clin Pathol (2017). A pdf of this article can be accessed by clicking the link below.

If you are interested in discussing provision of performance evaluation solution for products that you are developing, please get in touch either by email (info@newgene.org.uk) or phone (+44 191 241 8769).

Case studies and downloads:

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NewGene Limited
Bioscience Building
International Centre for Life
Newcastle upon Tyne

Tel: +44 (0)191 241 8769
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Email: info@newgene.org.uk

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NewGene Limited | Company Number: 06735445

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Agilent Technologies

Agena Bioscience


Sophia Genetics



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