The promise of precision medicine, with its focus on personalized treatments and earlier disease detection, holds immense potential to revolutionize healthcare. Yet, for many biomarker and diagnostics companies, the journey from groundbreaking discovery to real-world impact is fraught with obstacles. A significant hurdle lies in what we call the “Diagnostic Infrastructure Dilemma” – the substantial investment required by diagnostics companies to build and maintain the complex systems, processes, and technology stack necessary to support their core business functions.

The Myth of Uniqueness

Many diagnostic companies operate under the misconception that their infrastructure needs are unique. They invest heavily in building their own data management systems, software platforms, and operational logistics – tasks that every diagnostics company faces. This siloed approach not only diverts precious resources away from core research and development but also slows down the overall pace of innovation within the diagnostics sector.

Focus on Core Strengths, Not Infrastructure

Ideally, diagnostics companies should be able to concentrate their efforts on their core strengths:

• Developing novel biomarkers and assays: This involves cutting-edge research, sophisticated laboratory techniques, and a deep understanding of disease biology.
• Leveraging advanced technologies: Integrating artificial intelligence (AI), machine learning, bioinformatics and other cutting-edge technologies to analyze complex data, improve diagnostic accuracy, and personalize treatment plans.

However, the reality is often different. A significant portion of their resources and attention is diverted towards building and maintaining the infrastructure necessary to support these core functions.

• High Cost & Complexity: Building and maintaining a robust technology stack and operational infrastructure is expensive and time-consuming. It requires expertise in software development, data management, cybersecurity, and logistics.
• Integration Headaches: Seamless integration with electronic health records (EHRs), labs, and other platforms is crucial, adding another layer of complexity. For instance, integrating a new diagnostic test with a hospital’s existing laboratory information system can be a significant technical and logistical challenge.
• The R&D Squeeze: By diverting resources to infrastructure, companies have less to invest in R&D, hindering the very innovation that drives progress. This can stifle the development of novel technologies like liquid biopsies or AI-powered image analysis tools.

The Toll on Innovation

The consequences of this “go-it-alone” approach are significant:

• Low Commercialization Rates: Less than 1% of biomarker discoveries translate into clinical solutions. This stark statistic underscores the significant gap between scientific breakthroughs and their clinical translation.
• Prolonged Time-to-Market: Building and maintaining internal infrastructure can significantly delay the time it takes to bring a new diagnostic test to market. Literature review studies have found that the average time to bring a new diagnostic to market at any meaningful scale can exceed 17 years. This delay can have serious consequences, particularly for patients with life-threatening diseases where early diagnosis and treatment are crucial.
• Limited Access to Innovation: The high costs associated with building and maintaining infrastructure can create barriers to entry for smaller companies, hindering innovation and limiting the diversity of diagnostic solutions available to patients.

The Need for a New Paradigm

The current model, where each company attempts to build its own independent infrastructure, is unsustainable and inefficient. It hinders innovation, delays patient access to life-saving technologies, and ultimately slows down the progress of precision medicine. A new paradigm is needed, one that allows diagnostics companies to focus on their core strengths while leveraging shared resources and a more efficient infrastructure.

What if…

What if diagnostics companies could focus solely on their scientific breakthroughs, leaving the complexities of infrastructure management to specialized partners? What if they could access a shared pool of resources, expertise, and technologies, accelerating their time-to-market and maximizing their impact? This “what if” scenario represents a future where the Diagnostic Infrastructure Dilemma is no longer a barrier to innovation, but rather an enabler of progress in precision medicine with the potential to accelerate biomarker innovation 100x.

In the next part of this series, we will explore how Hurdle helps diagnostics companies overcome the Diagnostic Infrastructure Dilemma and accelerate the delivery of life-saving innovations.