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Every precision therapy is only as effective as the diagnosis that identifies who should receive it. Yet developing that diagnostic today requires an average of 15 handoffs between research-grade and clinical-grade development, a fragmented process that can delay patient access by months or longer. Danaher’s new Center for Enabling Precision Medicine was built to close that gap.
The 15-Handoff Problem in Companion Diagnostics Development
Companion diagnostics (CDx) determine whether a patient carries the biomarker targeted by a therapy, while complementary diagnostics help clinicians identify which broad treatment category is likely to help. For oncology drugs, especially, this distinction can be the difference between a treatment that works and one that does not.
The trouble is structural. Research-grade assay development, clinical validation, regulatory submission and commercial-scale manufacturing have traditionally lived with different vendors, labs and quality systems. Each transition adds its own risk of lost data, slipped timelines, and compounding cost.
The result is a development pathway that can stretch on for years before a single test reaches a clinician’s bench, even as the therapeutic it supports is ready to move forward. For health systems and facility planners tracking lab partnerships, that lag translates directly into delayed access for patients who might otherwise qualify for a targeted therapy the moment it clears regulatory review.
What Is Precision Medicine? Reframing the Drug Discovery Process
Once the textbook definition is stripped away, the more useful question is what it demands from the drug discovery process itself, since that is where timelines quietly break or hold. Traditional discovery optimizes a molecule first and worries about patient selection later, often well into clinical trials.
Precision medicine reverses that sequence. The biomarker and its diagnostic have to be validated in parallel with the drug candidate, not bolted on after Phase II data reveals which subpopulation actually benefits. That parallel-track requirement is exactly what stretches development timelines, since a diagnostic built on a shifting research schedule cannot simply wait for the therapeutic side to finish. The tighter the coupling between drug and diagnostic, the more the entire discovery process depends on infrastructure that moves at the same pace on both fronts.
The Centers for Enabling Precision Medicine
Danaher’s response consolidates that fragmented pathway into CLIA and CAP-certified laboratories that carry a project from early biomarker work through clinical-grade testing without switching facilities or systems. According to Julie Sawyer Montgomery, Executive Vice President at Danaher, the goal is to position the company as a connector across the diagnostics ecosystem rather than a single-point vendor.
The first center opened in Newcastle Upon Tyne, UK, hosted on Leica Biosystems’ campus, with a second facility in Carlsbad, California, adding immunohistochemistry, PCR and immunoassay capabilities. For pharma sponsors, the pitch is fewer vendor transitions, which means fewer places for a program to lose momentum, and a single quality system means fewer audits to coordinate across the development life cycle.
One Roof, Two Subsidiaries
What actually sits under that single roof is just as important as the certification itself. Leica Biosystems provides anatomic pathology and digital imaging tools, and Cepheid provides molecular diagnostics and PCR-based testing.
Bringing multi-modal capabilities together means a single biomarker program can move between tissue-based, molecular and cellular testing without re-contracting or re-validating equipment at every stage. The Newcastle facility achieved CLIA certification in January 2025, giving it the regulatory standing to run clinical trial phases testing directly rather than referring samples elsewhere for validation. This step historically added its own handoff to the pathway.
For a facility or operations team evaluating diagnostic partners, that kind of on-site regulatory standing is a meaningful signal. It means clinical-grade testing can be processed without shipping samples to a separate accredited lab and waiting for a second set of results.
Scaling Access Through a 30,000-Hospital Global Footprint
Consolidating development is only half the equation. Getting an approved diagnostic into clinical use at scale is the other. Danaher’s installed base of instruments spans more than 30,000 hospitals across 120 countries, giving newly developed assays a distribution network already in place rather than one that has to be built from scratch.
That footprint is already being tested commercially. Danaher entered into a partnership with AstraZeneca to scale precision medicine, initially focused on AI-assisted digital pathology tools to identify which patients are most likely to benefit from antibody-drug conjugates. Leica Biosystems alone enables 1.6 million cancer tests every week across that same installed base, a scale advantage few stand-alone diagnostics developers can match.
Why Speed to Clinic Matters for Precision Medicine
The stakes extend well beyond any single company’s lab capacity. The FDA maintains a public registry of cleared and approved companion diagnostic devices, a list that has grown steadily as more therapies require a matched test before a physician can prescribe them. As Amit Agrawal, chief scientific officer of Danaher subsidiary DH Diagnostics, wrote in STAT News, the central obstacle has never really been the therapeutics themselves. Still, the diagnostics infrastructure needs to match the right patient to the right drug.
Facility planners, regulatory teams and health system leaders evaluating lab partnerships have a direct stake in how quickly that infrastructure matures, since every consolidated development center or accelerated certification pathway shortens the distance between a promising biomarker and a test clinicians can actually order.
Passing the Baton Faster
Fifteen handoffs are not a law of nature. Instead, it’s a by-product of an industry that grew up in silos. Whether Danaher’s consolidated model becomes the standard or simply one credible path among several, the direction of travel is fewer transitions, faster validation and diagnostics infrastructure built to keep pace with the therapies it is meant to support.
