Diaceutics Partners With Global EQA Providers to Implement Best-in-class Testing Standards

• Partnerships are on Diaceutics’ DXRX platform – the world’s first diagnostic network for precision medicine
• Platform, launching in Q4 2020, has been purpose built to enable collaboration between key stakeholders in precision medicine to solve real-world biomarker testing issues
• Pharmaceutical companies will gain greater oversight of diagnostic testing standards for their new and planned precision medicines
• Will enable individual laboratories in Diaceutics’ global network of labs to benchmark test performances with labs across the globe, paving the way towards best-in-class testing on a global scale

PARSIPPANY, New Jersey–(BUSINESS WIRE)–Diaceutics PLC, (AIM: DXRX), today announces three new partnerships on its DXRX platform, as it continues with its mission to get every patient the treatment they deserve. 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.

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. (Read more…) 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.”

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About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX – the world’s first Network solution for the development and commercialization of precision medicine diagnostics. Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries. www.diaceutics.com

About CPQA-AQCP

CPQA-AQCP partners with diagnostic medical laboratories to maintain a high standard of biomarker testing by providing samples that allow labs to test their performance.

CPQA-AQCP is one of the products of the evolution of the Canadian Immunohistochemistry Quality Control (CIQC), originally founded in 2009, in response to the ever-changing landscape of diagnostic medical laboratory testing in Canadian and international laboratories. CPQA-AQCP continues to build on existing work to systematically monitor and improve the proficiency of medical laboratory testing across the country, facilitating participation by laboratories nationwide and internationally regardless of jurisdiction or existing accreditation requirements.

About EMQN CIC

EMQN CIC is a leading authority in quality assurance, committed to helping ensure diagnostic molecular genetic laboratory test results are accurate, reliable and comparable – wherever they are produced. The organization was established in 1998 after a successful pilot trial of a Huntington disease EQA scheme the previous year. From January 1999 to March 2002, the network was supported by a grant from the European Commission under the Standards Measurement and Testing Programme (contract number SMT4-CT98-7515). Since April 2002, EMQN CIC activities have been supported by subscriptions from EQA scheme participants and currently EMQN CIC offers molecular genetics, molecular pathology, and technique specific EQA schemes for molecular testing.

About NordiQC

Nordic Immunohistochemical Quality Control (NordiQC) is a global and scientific proficiency program for diagnostic Immunohistochemistry. NordiQC provides a range of relevant modules for immunohistochemical proficiency testing comprising both well-established and newly introduced immunohistochemical markers with central diagnostic and predictive value. NordiQC actively cooperates with all stakeholders being laboratories, industry and regulatory bodies to promote and establish standards for immunohistochemical precision testing. NordiQC is affiliated to and based at Department of Pathology, Aalborg University Hospital, Denmark. The program is independent, not-for-profit with no political interest. The scientific and diagnostic focus of NordiQC is supported and directed by international advisors.

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