Diagnostics save lives - it's time we act like it
London, UK – July 14th, 2025 — Diagnostics inform ~70% of clinical decisions, guide therapies, and often determine whether a patient lives, dies, or spends the next six months wandering through the healthcare system like a confused tourist without Google Maps. And yet, paradoxically, diagnostics remain one of the least appreciated, least funded (~2% of healthcare costs), and worst-branded sectors in healthcare.
In other words: diagnostics do most of the work, get almost none of the credit, and are then asked to justify their existence in triplicate. 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 trying to be seen somewhere between "lab expense" and "rounding error." 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.
Branding
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. Pharmaceuticals have commercials with sunsets, golden retrievers, and suspiciously attractive people walking on beaches. Diagnostics have… billing codes.
Maybe what the field needs isn't another company shouting for attention. It needs collective storytelling. Think "Got Milk?" but for biomarkers. Working slogans include "Got Spit?", "Know Before You Dose," and "Maybe Let's Not Guess?" Mascot TBD, though the llama continues to poll well.
Reimbursement
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 may average ~$185 in Medicare reimbursement, while the drug it enables can bill $150,000 per course. In other words, we routinely reimburse the $150,000 missile, then negotiate down the $200 targeting system as if accuracy were a luxury add-on. A therapy can glide through reimbursement. But the diagnostic that tells you whether to use it? Suddenly the entire system discovers fiscal discipline.
We need financial models that reward early detection and behavior-changing outcomes, not just throughput. Early detection spares ICUs, biopsies, late-stage interventions, and wheelbarrows of cash. Let's pay for what prevents catastrophe, not only what rescues us at the cliff's edge while wearing a very expensive cape.
Regulation
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.
And 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. No one issues a solemn PDF titled: "We regret to announce that our evidentiary bar was so pristine it became clinically useless."
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 what is lost, regulators will never be accountable for it.
Media
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. Saved lives get a footnote, if they're lucky.
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? Who's making the Netflix series about the diagnostic lab that quietly prevented a medical tragedy? Apparently, "competent molecular testing saves baby" does not have the same streaming appeal as "charismatic founder wears black turtleneck and commits fraud."
That asymmetry distorts public perception and fuels policy shaped by fear rather than fact. We need media partnerships that celebrate saved lives with the same intensity we reserve for scandals. The world does not need fewer cautionary tales. It needs more success stories.
The LDT Ruling
The 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 deeply conflicted. If a senior policymaker were diagnosed with cancer tomorrow, odds are they would want the latest and greatest guiding their care, even if it were an LDT rather than an FDA-approved test from a decade ago. Somehow, theoretical caution becomes much less comforting when the biopsy is yours.
And again, the system is rigged: agencies like the FDA or CMS are not 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 never reaches patients. Oversight is necessary. But oversight without accountability for delay needs to get fixed.
And yes, drug prices might also drop if regulatory red tape and clinical trial bureaucracy were less intense, but I digress. Briefly. Heroically.
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. The sector needs a coalition of diagnostics firms, patient advocates, policymakers, scientists, and yes, perhaps a few behavioral economists and storytellers who understand that humans are not Excel models with insurance cards.
Diagnostics deserve a seat at the center of healthcare strategy, not as a cost to contain, but as a lever to transform outcomes. We need to stop optimizing for cost per test and start optimizing for what truly matters: lives extended, treatments avoided, certainty delivered.
That last point matters. A test result is not just data. It is peace of mind. It gives patients the chance to reclaim their lives, make decisions, and regain control in a system that too often feels like a maze designed by committee.
The tools are ready. The technology is here. The science is no longer the bottleneck. What's missing is a shared drive to fight for diagnostics to be seen, valued, prioritized — and yes, even lobbied for. If we want to reduce healthcare costs and improve outcomes, we must invest smartly and boldly in diagnostics.
Diagnostics save lives. It's time we stopped treating them like a coupon code.