By Yuri Fesko, MD
As Vice President for Medical Affairs at Quest Diagnostics, I've had the privilege of witnessing and contributing to the remarkable evolution in oncology care. A significant aspect of this transformation, as detailed in our recent whitepaper, “The Evolving Role of Diagnostic Labs in Oncology: Navigating Biomarker-Driven Therapies,” is the rising influence of biomarker testing in the field of precision medicine.
Traditionally, diagnostic labs have played a crucial, albeit less visible, role in healthcare, focusing primarily on providing diagnostic services. Today, as our understanding of cancer’s molecular underpinnings deepens, labs have become central to the development and implementation of personalized therapies. Our whitepaper explores this important shift, including how diagnostic labs are transitioning from traditional service providers to proactive partners in oncology care.
A key element of this shift is biomarker-driven therapy. These therapies utilize molecular signatures to develop treatments targeted to specific cancer types or even individual tumors. A prime example is the use of the HER2 biomarker in breast cancer, which has led to the development of therapies like trastuzumab. Such advancements signify a move away from 'one-size-fits-all' treatments to more personalized strategies, enhancing treatment efficacy and reducing side effects.
This evolution in therapy development necessitates a reimagined approach in drug development. Biomarker-driven strategies streamline the development process, exemplified by the accelerated approval of drugs like pembrolizumab. This precision not only speeds up regulatory processes but also increases the likelihood of successful outcomes. However, this approach raises questions around the availability of assays for biomarker identification and the need for new companion diagnostics (CDx), challenges that can be overcome through collaboration between pharmaceutical companies and diagnostic labs.
Our whitepaper discusses the changing dynamics of drug and therapy development and the evolving role of diagnostic labs in this context. Diagnostic labs are now integral to the drug development process, advising on suitable clinical trial assays and CDx development. This collaborative spirit extends beyond therapy development to clinical implementation, ensuring therapies are quickly and efficiently integrated into patient care.
We also emphasize the importance of diagnostic labs in ensuring accurate treatment allocation. This includes expediting test results and collaborating with healthcare providers to streamline the transition from diagnosis to treatment decision-making. For example, Quest Diagnostics is actively working with its pathology group, Ameripath, to optimize these processes regardless of where the patient is, large academic medical center, suburban outreach clinic, or the rural cancer center.
Finally, we highlight the vital role that precision medicine plays in modern oncology care and how diagnostic labs have moved from the background to become key strategic partners in drug development and patient care. This collaborative approach not only speeds up the development and implementation of new therapies but also ensures that these advancements reach patients swiftly and effectively.