The Role of the Global Central Laboratory in Successful Companion Diagnostic Development

The Role of the Global Central Laboratory in Successful Companion Diagnostic Development

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Since the approval of the first companion diagnostic (CDx), HER2, in 1998, precision medicine has embraced companion diagnostics as one way to ensure that targeted therapies can be appropriately administered to the right patient with some degree of assurance following clinical validity within clinical trials.

Alan Wookey
Alan Wookey, Global Head
Companion Diagnostics
Q² Solutions

The clinical validity of the companion diagnostic tends to be the final piece before the assay is submitted for PMA in the US. Long before that, translational science investigations sought to determine which biomarkers might be used for patient selection in the context of safety and/or efficacy. For these biomarkers, they have tended to fall into four main technology categories: Immuno-histochemistry (IHC), fluorescent in situ hybridisation (FISH), molecular via PCR and next generation sequencing (NGS). Although more recently, flow cytometry and immunoassay approaches are being considered for CDx.

Oncology remains the dominant therapeutic area, and indeed, most solid tumor clinical development patient selection is built into the clinical trial. Lymphoma and leukaemia indications increasingly have biomarker analysis built into their clinical development plans. Given that each of these technology approaches requires pathology review (typically confirmation of diagnosis and assessment of tissue containing cells of sufficient quantity and quality), it’s imperative that these pathologists are integral within the global central laboratory set up. Often, these pathologists will serve as principal investigators. At Q2 Solutions, this forms the foundation for much of what the laboratory provides to support global CDx.

Q2 Solutions CDxDevelopment DiagramSuccessful partnerships between therapeutic sponsors, global central laboratories, and in vitro diagnostic companies (IVD) are critical to moving these CDx programs through clinical development. At Q2 Solutions, we work closely with IVD companies to ensure we have the appropriate equipment and instrumentation, plus adequately trained staff.

Regulatory and ethics compliance are key to ensuring these CDx studies are conducted in accordance with national and local guidelines. Accordingly, it’s important to have personnel who can work with ethics and regulatory bodies. For studies involving China, Q2 Solutions ensures that appropriate HGRAC and NMPA guidelines are adhered to and provides reassurance to its pharma and IVD partners given its long experience with these bodies. Many oncology global phase III studies involve clinical sites in China, and given the regulations limiting or prohibiting the export of biological samples, having a local solution in China is a prerequisite.

Providing biomarker results to clinical trial sites within fast turnaround times is almost a ubiquitous requirement given that patients may have the option of several clinical trials and that often, their disease management requires results quickly as therapeutic options are approved or investigational methods are being assessed. Q2 Solutions’ default position is to provide results back to clinical sites within five business days of sample receipt.

Increasingly, more and more biomarker data is available locally with patients at clinical sites. Often, this local data is being used for the biomarker selection criteria in the clinical study. In our experience, lab data collected at different labs with different quality systems, often using different technologies, is not ideal and more often, sponsors require confirmation within a central laboratory.

The global central laboratory continues to provide crucial laboratory data, often to support the decision to place a patient on an investigative therapy in a clinical trial. With the crucial elements discussed, the global central laboratory will continue to be a critical player in the pursuit of precision medicines for the patients who need them most.


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