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Alan Wookey, VP companion diagnostics, Q2 Solutions, has worked in the companion diagnostic (CDx) space for 20 years, having had scientific roles in pharmaceutical clinical development, clinical diagnostics, and presently at a global central laboratory.

Since the first significant CDx approval, by way of Herceptest for Herceptin in 1998, precision medicine approaches have been used to identify patients likely to have a meaningful clinical response through better efficacy and/or better safety profile. CDx assays have been used for many patient selection programs in clinical development and indeed, many of those approved assays are now standard of care.

Alan Wookey
Alan Wookey
VP Companion Diagnostics
Q2 Solutions

CDx developments typically are first analytically validated either by in-vitro diagnostic companies or by individual laboratories as laboratory developed tests (LDT). They are then clinically validated in clinical trials alongside a therapeutic as a co-development with the goal of simultaneous approval.

Q2 Solutions, as a global clinical trial laboratory organization, has an established global footprint by providing precision medicine biomarker data from its five global locations. This service often supports the unique needs of companion development programs.

What are the typical development paths for a CDx?

Development of an IVD for broad commercial access or the development of LDTs that initially gain approval at single testing sites in the first instance. The success of the latter approach has often utilized next generation sequencing (NGS) technology to derive mutation data.

The IVD model involves the use of an investigational use only (IUO) product from IVD companies. In this model, central laboratories like Q2 Solutions provide testing data to a clinical site for inclusion/exclusion purposes and provide that data to the IVD company for their submission.

Immunohistochemistry (IHC) is the most adopted technology in our experience.

Will the recent IVDR implementation in the EU and the changing LDT framework in the U.S. affect LDT CDx development?

The IVDR requirements mean that for a central laboratory (which don’t typically have healthcare facility status) that is developing an LDT or any assay that is being used as part of a patient’s management, a quality management system needs to be in place, typically ISO13485.

Similarly, in the U.S., the recent ruling on LDT’s by FDA means that enforcement discretion of investigational assays in most cases will cease. Accordingly, the laboratory will be required to provide extra documentation and design control process and to be compliant with 21CFR 812.

Why is Q2 Solutions well placed to support CDx programs?

Q2 Solutions has a network of more than 30 anatomical pathologists to review and read slides. They also serve as assay principal investigators. Furthermore, Q2 Solutions ensures that its laboratories and instruments are qualified by the IVD companies, thereby providing efficient qualification and training for the assay. Q2 Solutions has a dedicated CDx delivery group comprised of regulatory specialists and study coordinators. For global studies, its Beijing facility has supported more than 60 CDx projects, leveraging local expertise to navigate HGRAC requirements.

There is often a requirement to report the test results back to the clinical sites quickly. Q2 Solutions maintains a metric of reporting 95% of results within five business days from sample receipt.

What are the key considerations for successful CDx development?

Experience has taught us that a partnership model be adopted between pharmaceutical, IVD, central lab, and CRO. A shared vision is best implemented. The typical needs for a pharmaceutical company would include the ability to move quickly and to be flexible, quality testing and fast turnaround time, and regulatory knowledge and vision for commercial testing. For the IVD company, typical needs include assurances of aligned compliance across the different laboratories, risk assessment with accepted tolerances, clearly defined and timely deliverables, and alignment on the processes for training and proficiency. For the central lab, typical expectations would include understanding of clinical context and timelines, open communication channels, unabated supply of the IUO assay, and timely training and proficiency testing of its laboratory personnel.

What can we expect for the future and how will Q2 Solutions be able to respond?

We can anticipate therapy areas other than oncology to embrace precision medicine with assays for CDx. We await the impact of IVDR and FDA ruling on LDTs on the desire to pursue LDT path for CDx development. Technology continues to evolve, and Q2 Solutions is at the forefront to embrace the opportunities presented in digital pathology multi-plex IHC, and potentially flow cytometry. Q2 Solutions, with its expansive flow cytometry footprint and its ability to adopt the latest platforms, is well positioned should this approach be adopted.


For more information: www.q2labsolutions.com.

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