The tipping point of cancer biomarker quality

  • Dario Trapani
Immunotherapy Therapy Staging and Imaging

Dario Trapani

Having high-quality biomarkers is the essential presupposition to deliver impactful targeted treatments. When the reliability of cancer biomarkers is uncertain and rapidly changing, there is a substantial risk to prescribe inappropriate treatments to patients, with detrimental consequences.

Too often the access to quality biomarkers is undermined by poor knowledge on the need for quality assurance. Relying on the assumption that biomarkers bring ‘innovation’ without claiming quality may be appealing to some, perhaps not really to medical conservatives – and not to patients, for sure.

In this sign thou shalt conquer. In other words, should we blindly follow the information (‘sign’) any biomarker gives us? The relevance of diagnostic harmonisation and quality metrics have been literally ‘besieged’ and then ‘conquered’ by the excitement to enumerate more predictive biomarkers. This can be a mirage of improvement if biomarkers are viewed ubiquitously reproducible and deterministic, while ignoring the need for trusted laboratories that attain rigorous standards for medical diagnostics. In a logical sequence, the quality assurance of biomarkers is the fundamental premise for safe and effective treatments. In practice, however, distortions of logic result in absurd statements on drug efficacy alone.

Today, the results of a multistakeholder initiative of the International Quality Network for Pathology, the European Cancer Patient Coalition, and the European Federation of Pharmaceutical Industries and Associations were presented, which evaluated the key metrics of access to, and quality of, cancer biomarkers in Europe (Abstract 1505MO, ESMO Congress 2021, 18 September, 17:30 – 18:30 CEST, Channel 5). The mapping exercise identified relevant barriers to access to predictive biomarker testing. Among them, unclear approaches to value assessment of diagnostic tests, diverse infrastructure and capabilities of laboratories, limited education among stakeholders and inconsistent participation of laboratories in quality assurance schemes emerged as principal factors affecting access to diagnostics and the delivery of precision medicine-based treatments.

The initiative is instrumental in shaping evidence-informed, data-driven health policies, to ensure best practice, tackle inconsistencies and monitor progress towards quality improvements in oncology care, and ultimately boosting access to cancer treatments. The only way to build a better oncology setting is through better quality of cancer care.

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