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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 oncology pharmaceutical development, clinical diagnostics, and presently at a global central laboratory.
CDx, as a tool for realizing precision medicine to enable targeted therapies, has been in clinical practice for over 30 years. However, it was the approval of Herceptin for breast cancer with an associated companion assay—Her2—in 1998 that began a concerted effort across the industry to validate and implement these specialist biomarker assays. This implementation has provided improvements in therapeutic options for diseases that were previously treated empirically. While the majority of these programs have been in oncology, other therapeutic areas are now beginning to adopt precision medicine strategies.
Q2 Solutions, as a global clinical trial laboratory organization, has strengthened its CDx footprint by providing precision medicine biomarker data from its five global locations. This support is aimed at meeting the unique needs of companion development programs.
IPM: What are the typical development paths for a CDx?
With more than 50 FDA approvals for a CDx assay linked to therapeutics, the paths have generally been either development of an IVD for broad commercial access, or the development of laboratory developed tests (LDT’s) that initially gain approval at single testing sites in the first instance. The success of the latter approach has typically relied on next generation sequencing (NGS) technology to derive mutation results, which in turn guide the use of corresponding targeted agents for treatment. More recently, those approvals in oncology have been tumor agnostic, expanding the range of disease indications from a particular NGS output.
The former model involves the use of an investigational use only (IUO) product from IVD companies. In this model, central laboratories like Q2 Solutions play a key role in delivering testing data to a clinical site for inclusion/exclusion purposes and providing that data to the IVD company for their submission. Immunohistochemistry (IHC) and fluorescent in-situ hybridization (FISH) technologies are now using, and have historically used, this route, with PD-L1 and ALK as examples.
IPM: Why is Q2 Solutions well placed to support CDx programs?
Q2 Solutions has a network of greater than 30 anatomical pathologists who cover most of the tumor subspecialties. In addition to pathology review and the reading of slides, they also serve as assay principal investigators. Furthermore, Q2 Solutions ensures that its laboratories and instruments used in the process 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 specialist and study coordinator personnel. For global studies, its Beijing facility has supported more than 60 CDx projects leveraging local expertise to navigate HGRAC requirements.
Given the nature of precision medicine clinical trials in the oncology disease setting, there is often a requirement to report the test result back to the clinical site within a fast turnaround time. Q2 Solutions maintains a metric of reporting 95% of results within five business days from sample receipt.
IPM: What are the key considerations for successful CDx development?
Experience has taught us that partnership structure and cadence are crucial for a successful CDx program. Typically, four different companies are involved: Pharmaceutical, IVD, Central Lab, and CRO. Three-way, or even four-way, agreements help align and ensure efficient understanding for robust yet speedy decision making, rather than relying on multiple two-way agreements. A shared vision is best implemented by a cross-party understanding of the individual needs. For the pharmaceutical company, typical needs would include the ability to move quickly and to be flexible, quality testing and fast turnaround time, regulatory knowledge, and forward vision for commercial testing. For the IVD company, typical needs would 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 pathologists and laboratory personnel.
IPM: 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 are witnessing a growing number of requests for LDTs with pivot to IVD development later in clinical trials. This approach helps mitigate the associated costs with CDx development in early stage programs. Technology continues to evolve, and Q2 Solutions is at the forefront to embrace the opportunities presented in digital pathology and multiplex assays. More recently, there has been increasing interest in using flow cytometry as a technology for CDx. 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
