Karan Arora, senior vice president of advanced assays, AI, and pharma
services at Leica Biosystems outlines the critical role diagnostics have to play in unlocking the promise of precision medicine.
services at Leica Biosystems
The global healthcare community is bracing for one of its most formidable challenges: by 2050, global cancer cases are projected to surge to 35 million, according to the American Cancer Society. At the same time, globally, one in five individuals are expected to develop cancer in their lifetime, making this not just a medical crisis, but a societal imperative. This trajectory demands bold innovation and a more personalised approach to detection, diagnosis and treatment – beginning with the early integration of companion diagnostics into drug development.
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Precision oncology has emerged as one of the most transformative trends in medicine, promising treatments tailored to the unique molecular profiles of cancers in individual patients. This approach moves beyond the traditional “one-size-fits-all” model and instead focuses on delivering therapies that are more effective and better aligned with patient-specific biology. Yet, for this vision to be fully realised, robust cancer biomarkers – and their translation into companion diagnostics – must advance in parallel with therapeutic innovation.
As cancer incidence rises across diverse geographies and demographics, healthcare systems must prioritise accuracy, agility, and accessibility in treatment delivery. While standardised protocols provide consistency, the future lies in individualised care pathways that restore health efficiently and equitably.
The role of companion diagnostics
Companion diagnostics (CDx) are tests designed to identify which patients are most likely to benefit from a specific therapy by identifying specific biomarkers – such as genetic mutations, protein expression levels, or other molecular features – linked to a drug’s mechanism of action. They enable clinicians to match treatments to patients with precision – improving outcomes and reducing unnecessary exposure to ineffective drugs.
Despite their importance, CDx development often lags behind drug development. Diagnostics are frequently introduced late in the process – sometimes after a therapy has already reached advanced clinical trials. This delay creates bottlenecks, slows regulatory approvals, and limits the speed at which life-saving treatments reach patients.
Biomarker-driven innovation
In precision oncology, the success of targeted therapies depends on identifying molecular targets that are not only pharmacologically actionable but also biologically relevant. This is where CDx, grounded in biomarker science, become indispensable. Biomarkers – measurable indicators of underlying biological processes – bridge molecular insights and clinical application, validating which targets truly matter.
Biological relevance goes beyond detectability; it reflects the degree to which a molecular alteration drives tumorigenesis, correlates with disease progression or prognosis, and influences therapeutic response or resistance. Mutations in oncogenes such as EGFR (Epidermal Growth Factor Receptor) or BRAF (B-Raf Proto-Oncogene) are not just detectable – they fundamentally shape cancer biology and dictate treatment strategies. Biomarkers establish this relevance by linking genetic changes to functional outcomes in cancer cells, enabling researchers to distinguish between incidental findings and bona fide cancer-driving events and clinically actionable targets.
This biomarker-driven approach can fuel innovation across the entire development continuum. It informs drug discovery, optimises trial design by enriching for responsive patient cohorts, and supports regulatory approval through robust evidence of clinical utility. Ultimately, cancer biomarkers are the cornerstone of precision oncology, ensuring that therapies are not only scientifically sound but also deliver meaningful benefit to the patients who need them most.
Benefits of collaborative development
When diagnostics are developed in tandem with therapies, one of the most significant advantages is the acceleration of time-to-market. Co-development enables both the therapeutic product and its companion diagnostic to progress through research, validation, and regulatory preparation simultaneously, rather than sequentially.
This alignment streamlines regulatory submissions, as agencies increasingly favour integrated review processes for precision medicine solutions. By ensuring that the diagnostic tool is ready at launch, clinicians can immediately identify the right patient population. This dramatically improves treatment outcomes while reducing delays in patient access.
Embedding diagnostics into clinical trial design also enhances enrollment efficiency and reduces screening failures, ultimately shortening development timelines and lowering costs. This approach accelerates commercialisation and delivers a decisive competitive edge in the rapidly evolving therapeutic landscape – crucial in a race against time for some of the most critically ill patients.
The road ahead
Co-development does not come without challenges – biomarker discovery and validation require rigorous research and scientific data. Yet these challenges are manageable, and the opportunities far outweigh the obstacles. Advances in genomics, digital pathology, and AI-driven analytics are making biomarker identification faster and more accurate. As healthcare systems grapple with rising patient numbers and limited resources, the demand for precision medicine will continue to accelerate.
The future of oncology depends on deep, cross-sector collaboration. By working together from the earliest stages of drug discovery, stakeholders – including academic and research organisations, healthcare institutions, pharmaceutical companies, and diagnostic providers – can create a seamless pipeline that accelerates innovation, improves patient outcomes, and reduces healthcare costs.
For precision medicine to realise its potential, it is imperative that companion diagnostics are innovated alongside targeted cancer therapies right from the start of the drug discovery process. To accomplish this, strategic partnerships will be essential, defining the next era of cancer care. Academic and research organisations contribute foundational science and biomarker discovery, while healthcare institutions provide real-world clinical insights and patient access. Pharmaceutical companies drive therapeutic development, and diagnostic providers ensure that companion diagnostics are integrated early to enable precision treatment. This synergy not only brings targeted therapies to market faster but also improves patient outcomes, optimises trial design, and reduces overall healthcare costs. Ultimately, diagnostics are not just an accessory to therapy – they are the lynchpin that unlocks the full promise of precision medicine.
