A new analysis from the University of California, San Francisco (UCSF) highlights a critical gap in modern healthcare: diagnostics are often overlooked despite their essential role in guiding treatment decisions. Diagnostics, which include medical tests used to match patients with the most appropriate therapies, are receiving far less attention than drugs or surgical treatments.
According to the study published in Science, this imbalance is slowing progress against major diseases even as targeted therapies and precision medicine continue to advance rapidly.
Limited Access to Diagnostics Worldwide
The analysis points out that nearly half of the global population lacks adequate access to diagnostic tests. In addition, diagnostics receive significantly less investment in research and development compared with pharmaceutical therapies.
Moreover, insurance reimbursement for diagnostic tests is typically much lower than for medications. As a result, these financial and policy barriers restrict innovation and limit the widespread adoption of new testing technologies.
Kathryn Phillips, PhD, Professor of Health Economics at the UCSF School of Pharmacy and lead author of the study, emphasised the importance of diagnostics in clinical decision-making. She noted that while people easily recognise the benefits of new drugs or surgical procedures, the tests that guide these medical decisions are equally critical to patient care.
Treatment Advances Outpacing Diagnostic Development
As reported by medicalxpress, the study also reveals that therapeutic innovation is progressing faster than the development of diagnostic tests required to guide treatment selection.
For instance, GLP-1 medications used for obesity and diabetes have gained widespread attention. However, many patients do not respond to these drugs, and currently few diagnostic tests exist to predict which individuals will benefit most from these therapies.
Similarly, advancements in Alzheimer’s disease treatment highlight this growing gap between therapy and diagnostics.
Diagnostic Costs and Insurance Barriers
Although new medications can help slow the progression of Alzheimer’s disease, the diagnostic tests needed to identify suitable patients remain expensive and poorly reimbursed.
For example, blood tests designed to determine which patients may benefit from these treatments can cost around $1,000. In contrast, the medications themselves may cost approximately $30,000 per year and are more likely to receive insurance coverage.
Consequently, physicians may have to make treatment decisions without complete diagnostic information. This situation can result in some patients receiving ineffective therapies while others may not receive treatment at all.
Regulatory and Policy Misalignment
Another challenge identified in the study is the misalignment between regulatory and reimbursement systems for diagnostics and treatments.
Although diagnostic tests are essential for effective healthcare, regulators and insurers often evaluate them separately from the therapies they support. For example, the U.S. Food and Drug Administration (FDA) reviews diagnostic tests differently than drugs, while insurance providers apply separate reimbursement policies.
Furthermore, pharmaceutical drugs are far more likely to receive expedited regulatory review compared with diagnostic technologies.
Robert M. Califf, MD, former Commissioner of the U.S. FDA and co-author of the study, emphasised that regulatory and payment policies must evolve alongside scientific and technological progress.
He noted that the current system creates a disconnect between the approval and reimbursement processes for diagnostics and those for drugs. As a result, many valuable diagnostic tools remain underused, and healthcare providers lack sufficient data to determine which tests offer meaningful clinical benefit.
Policy Recommendations to Strengthen Diagnostics
To address these challenges, the researchers propose several policy reforms aimed at improving the role of diagnostics in healthcare.
First, policymakers should evaluate diagnostic tests and treatments together, recognising their interconnected roles in patient care. Additionally, regulatory authorities could streamline approval processes for diagnostic technologies to accelerate their availability.
Finally, healthcare systems should improve reimbursement structures and evaluation frameworks for diagnostic tests, ensuring that they receive appropriate recognition and funding.
Recognising Diagnostics as Essential to Healthcare
Ultimately, the authors hope the analysis will encourage broader recognition of the importance of diagnostics in modern medicine.
Phillips explained that the goal is to help patients, policymakers, insurers, and researchers understand that diagnostics are fundamental to effective healthcare. Rather than being treated as an afterthought, diagnostic technologies should be viewed as essential tools that enable precision medicine and improve patient outcomes.
