Diagnostics save lives – it’s time we act like it

London, UK – July 14^th, 2025 – Diagnostics inform ~70% of clinical decisions, guide therapies, and often determine whether a patient lives or dies. And yet, paradoxically, they remain one of the least appreciated, least funded (~2% of healthcare costs), and worst-branded (0% of the credit!) sectors in healthcare. We don’t have a diagnostics problem; we have a perception problem.

While precision medicine makes headlines with miracle cures and billion-dollar drugs priced like unicorn tears, diagnostics toil in the background, shaping outcomes, fighting for CPT codes, and struggling to be seen. The industry has failed to craft a compelling public or political narrative. We've let bean counters dictate pricing, allowed regulatory perfectionism to paralyze innovation, and watched media sensationalism erode public trust.

Here’s the reality: diagnostics are being left behind, and patients are paying the price.

Let’s start with branding. Diagnostics don’t just suffer from invisibility, they suffer from an identity crisis. Despite their centrality to care, the sector lacks brand leadership and unifying voices. Maybe what the field needs isn’t another company shouting for attention; it needs collective storytelling. Think “Got Milk?” but for biomarkers. Working slogan: “Got Spit?” Mascot TBD, though the llama polls well!

This absence of unity shows up in policy and reimbursement. Most diagnostics companies spend years fighting for payment that barely covers their overall operating costs. A first-line molecular test averages $185 in Medicare reimbursement, while the drug it enables can bill $150,000 per course. That’s not economics, that’s a failure of imagination. We need financial models that reward early detection and behavior-changing outcomes, not just throughput. Early detection spares ICUs, biopsies, and wheelbarrows of cash. Let’s pay for what prevents catastrophe, not only what rescues us at the cliff’s edge.

Just as insidious is the regulatory drag on innovation. Payers and agencies like the FDA demand near-flawless evidence before greenlighting new diagnostics, ignoring the lives lost due to delay or lack of access. They call for randomized trials and ironclad endpoints from tools designed for real-world messiness. In the name of rigor, we’ve weaponized perfectionism. Yet no one is held accountable for the opportunity cost. When a promising test dies in the valley of death, patients die too. But there’s no press release for that. Healthcare systems track adverse events down to the decimal. Rarely do they track the dad who relapses because an unfunded ctDNA test wasn’t run. It’s playing tennis without the net - if we don’t measure that loss, regulators will never be accountable for it.

And the media? No favors there. Sensationalism sells. Theranos became a household name and still gets more airtime than the 27,000 U.S. lives extended annually by modern colorectal-cancer screening. False positives get headlines. But who’s writing about the six-day-old newborn in the NICU, whose life was saved by rapid whole-genome sequencing that pinpointed a mutation causing pyridoxine-dependent epilepsy, allowing doctors to halt her seizures with high-dose vitamin B6 within hours? That asymmetry in coverage distorts public perception and fuels policy shaped by fear rather than fact. We need media partnerships that celebrate saved lives with the same fervor we highlight scandals.

The (thankfully) recently vacated LDT ruling is a prime example. The FDA’s push for broader oversight may have been well-intentioned (and not without merit) but it was also hypocritical. If a senior policymaker were diagnosed with cancer tomorrow, odds are they’d want the latest and greatest guiding their care, even if it were an LDT rather than an FDA-approved test from a decade ago. And again, the system is rigged: agencies like the FDA or CMS aren’t held responsible for lives that could have been saved had a test been available. They take credit for the safety of marketed products, without accounting for what’s missing. Oversight is undoubtedly necessary, but it’s gone too far, for both diagnostics and pharma. (And yes, drug prices might drop if regulatory red tape and clinical trial bureaucracy weren’t so intense, but I digress.)

So, what do we need? Bold, coordinated leadership, not just from individual companies, but from the entire diagnostics ecosystem. We must elevate the category, communicating the life-saving value of diagnostics not just through data, but through stories that resonate. That means building a coalition of diagnostics firms, patient advocates, policymakers, and scientists to push back against paralyzing demands and shift the narrative, from cautious skepticism to informed urgency.

Diagnostics deserve a seat at the center of healthcare strategy, not as a cost to contain, but as a lever to transform outcomes. To get there, we may need behavioral economists and storytellers alongside lab directors and clinical scientists to inform the public to demand access to these tests. We need to stop optimizing for cost per test and start optimizing for what truly matters: lives extended, treatments avoided, and certainty delivered. That last point is critical: a test result isn’t just data; it’s peace of mind. It gives patients the chance to reclaim their lives and regain a sense of control.

The tools are ready. The technology is here. What’s missing is a shared drive to fight for diagnostics to be seen, valued, and prioritized. And yes, even lobbied for. If we want to reduce healthcare costs and improve outcomes, we must invest (smartly and boldly) in diagnostics.

P.S.: We recently filmed a Media Day at DeciBio (videos coming soon, pending some marketing magic). As I rambled on camera trying to land a point, I realized a clearer blog post might help, especially for those who struggle with my accent! Think of this as the director’s cut…but with punctuation.

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Author: Stephane Budel, Partners at DeciBio Consulting, LLC

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