On September 28, 2020 Diaceutics PLC, (AIM: DXRX), reported three new partnerships on its DXRX platform, as it continues with its mission to get every patient the treatment they deserve (Press release, Diaceutics, SEP 28, 2020, View Source [SID1234567693]). The company has signed agreements with external quality assessment (EQA) organizations Canadian Pathology Quality Assurance – Assurance Qualité Canadienne en Pathologie (CPQA-AQCP), European Molecular Genetics Quality Network (EMQN CIC) and Nordic Immunohistochemical Quality Control (NordiQC). The partnerships will help to establish best-in-class global laboratory standards for diagnostic testing through in-lab quality assurance and will provide the transparency which pharmaceutical companies need to reach more patients with their precision medicines.
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"Establishing partners in quality within the industry is important for CPQA-AQCP and we are excited with this opportunity to evolve our relationship with Diaceutics and participate in the DXRX network. "
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By partnering with CPQA-AQCP, EMQN CIC and NordiQC on DXRX – the world’s first diagnostic network for precision medicine – Diaceutics will support the implementation of accurate and high-quality testing across its 2500+ laboratory relationships.
These collaborations facilitate a critical piece of the end-to-end solution which DXRX enables for the development and commercialization of precision medicine diagnostics. They are also part of multiple partnerships which Diaceutics is building with industry providers across the globe to help achieve their mission of getting every patient the treatment they deserve.
Currently focused on the Canadian market, CPQA-AQCP is dedicated to monitoring and improving the proficiency of immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) testing. DXRX is a global platform which will enable CPQA-AQCP to expand its services further worldwide. The organization is currently collaborating with Diaceutics on a project sponsoring the HER2 biomarker modules for gastric cancer. Using IHC and FISH, they are assessing the landscape and efficiency of HER2 gastric cancer testing, which has now been on the market for more than 10 years.
UK-based EMQN CIC provides molecular genetics, molecular pathology, and technique-specific EQA schemes for the global molecular testing market. It is currently collaborating with Diaceutics on a pilot study involving mutations in the EGFR, PIK3CA, KRAS, HRAS, NRAS, KIT, TP53 and BRAF genes, which will help laboratories using high throughput technologies – such as NGS – to accurately validate assay sensitivity and specificity. Data will be generated for a white paper to demonstrate a real-world review on NGS usage for clinical purposes: where we are today and the market readiness for additional biomarkers.
NordiQC is a global and scientific proficiency program for diagnostic Immunohistochemistry with more than 500 participants. NordiQC provides a broad range of relevant modules for immunohistochemical proficiency testing within diagnostic pathology and with special attention to predictive biomarkers. By joining the DXRX network, NordiQC strengthens its mission to bridge all stakeholders in diagnostic precision testing to optimize and standardize this field.
The addition of CPQA-AQCP, EMQN CIC and NordiQC on DXRX complements recent partnerships announced with HistoCyte Laboratories and Targos Molecular Pathology, which provide control slide materials and training for laboratories respectively.
John Garratt, Director, CPQA-AQCP, said: "Establishing partners in quality within the industry is important for CPQA-AQCP and we are excited with this opportunity to evolve our relationship with Diaceutics and participate in the DXRX network.
"Personalized medicine requires precision diagnostics to ensure the therapies are targeted accurately, thus providing optimum outcomes for patients. There is a greater demand on labs to provide prognostic biomarker testing of more esoteric targets and we, in EQA organizations, need to provide support for establishing the tests and for maintaining quality of the tests so that patients and their oncologists are confident that the most effective therapy is being used.
"Working with Diaceutics and its established partners is a great opportunity for CPQA-AQCP to assure accurate and sustainable pharma-diagnostic testing."
Simon Patton, Managing Director, EMQN CIC, said: "EMQN CIC and Diaceutics have a shared vision on improving the quality and accuracy of testing to ensure all patients get access, where possible, to the most effective treatments. We are delighted to be offering our ISO 17043 accredited Oncogene panel testing EQA scheme through the DXRX platform to support these goals."
Søren Nielsen, Director of NordiQC, said: "It’s with great expectations and excitement we enter the cooperation with Diaceutics. The partnership is driven by mutual interest and goal to raise and secure the global level of immunohistochemical precision testing and only by broad collaboration between laboratories, pharma, industry, regulatory bodies and EQA programs this can be accomplished."
Karina Hjort, Senior Director of Innovation, Diaceutics, said: "The precision medicine market is growing rapidly. Approximately 1,000 precision medicine drugs are currently in development and our research shows that by next year, the FDA will be approving more personalized oncology drugs than one-size-fits-all treatments. As they shift towards a personalized approach to treating patients, pharmaceutical companies must ensure that they are choosing the correct solutions and services to fulfil the promise of their precision medicines.
"We are delighted to have CPQA, EMQN CIC and NordiQC join the DXRX network to enable a critical piece of an end-to-end development and commercialization solution designed to get every patient the treatment they deserve."