Once again Illumina has published its Diagnostics Year in Review. See CY2025 in a birdseye view, edited by Mara Aspinall, 48pp.
##
AI CORNER
##
TL;DR ? Should you read this 48-page “Diagnostics Year in Review”?
Yes—if you care about where genomics, AI diagnostics, and reimbursement policy are actually heading, not just headlines. This is one of the clearest “industry synthesis” decks of the year, and it quietly encodes several policy-relevant signals that CMS/FDA watchers will recognize immediately.
The report argues that 2025 marks a shift from post-COVID recovery to a true “diagnostics renaissance.” That’s not hype—it’s grounded in three converging forces:
Regulatory relief (LDT rule vacated → innovation unlocked)
Platform shift (tests → data/AI-driven clinical decision engines)
Capital re-consolidation (massive M&A + “Terrific Ten” winners emerging)
Why your readers may want to read it
First, it reframes diagnostics as a platform business, not a test business.
The most important conceptual shift is that leading companies are no longer selling assays—they are building data + AI platforms with recurring revenue and pharma tie-ins. That aligns directly with how CMS, MolDx, and investors are starting to think about value (not per-test, but per longitudinal insight).
Second, it quietly validates the LDT-centric model.
The report explicitly notes that all of the top-performing companies launched as LDTs and many stayed that way—and that the 2025 court decision removing FDA’s LDT rule “overhang” restored confidence.
That’s a major policy signal.
Third, it captures the paradox your readers live in:
Innovation exploding (multi-omics, MRD, AI)
Reimbursement still compressing (PLA payments down ~60%)
Commodity testing under price pressure (classic CLFS/PAMA story)
Fourth, it shows where growth actually is (and isn’t).
Molecular/genetic testing: +70% vs 2019 baseline
Traditional pathology: still lagging
OTC / at-home / wearable diagnostics: accelerating rapidly
Fifth, it’s a deal and capital markets story as much as a science story.
2025 had ~$60B+ in diagnostics M&A—nearly a decade’s worth in one year
That signals consolidation around a few dominant platforms.
Highlights (what to skim for if you don’t read all 48 pages)
“Terrific Ten” companies redefining diagnostics economics (NGS + AI + recurring revenue)
LDT rule vacated → major regulatory inflection point
PLA explosion but declining pricing → volume up, value per test down
Liquid biopsy + MRD + early detection → central clinical battleground
AI + multi-omics = new moat (not just wet lab anymore)
Biomarker-driven medicine still underused clinically despite huge growth
Shift to at-home + DTC + wearable diagnostics
Bottom line
This is not just a “year in review.”
It’s a roadmap for where diagnostics value is migrating:
From individual tests → longitudinal data platforms → AI-enabled clinical decision systems tied to pharma and reimbursement strategy.
If you’re writing about CMS, MolDx, ADLTs, or coverage strategy, this deck is basically a coded industry brief on what companies are optimizing for next.
Five Surprises
The winners are mostly still LDT-based, despite years of FDA pressure to formalize into IVD pathways.
PLA usage exploded—but reimbursement per test fell ~60%, a striking disconnect between adoption and value.
2025 M&A volume (~$60B) nearly equals the prior decade combined, signaling a rapid consolidation phase.
Diagnostics IPOs from the COVID era performed poorly, while newer entrants are stronger—timing mattered enormously.
Only ~50% of cancer patients get biomarker testing today, despite it being central to modern oncology—huge remaining gap.
