PatientSpotlight, by PanaceaIntelPatientSpotlight

Topic

Biomarkers

Coverage of the biomarker tools the field uses to identify disease and stratify treatment - imaging, plasma, tissue, and genetic markers - and how validation work is reshaping which tools matter when. 51 pieces on this topic across therapy areas, newest first within each collection.

Signals

29
SignalNEWMay 8, 2026

Thyroid cancer targeted therapy expands across differentiated, medullary, and anaplastic subtypes

RET inhibitor maturity, NTRK fusion-targeted use, BRAF V600E and MEK combinations in anaplastic disease, and emerging mechanism programs are restructuring thyroid cancer therapy.

TreatmentBiomarkersPipelineDrug development
SignalNEWMay 8, 2026

Lung cancer screening pathway integration matures

Low-dose CT screening adoption growth, AI-assisted nodule management, blood-based biomarker integration, and primary-care pathway formalisation are restructuring lung cancer screening.

DiagnosisBiomarkersPatient journeyInfrastructure
SignalNEWMay 8, 2026

Allergic bronchopulmonary aspergillosis management widens past corticosteroids and itraconazole

Biologic therapy in ABPA, novel azole maturity, and structured diagnostic-and-monitoring pathways are reshaping allergic bronchopulmonary aspergillosis management.

TreatmentBiomarkersPipelinePatient journey
SignalNEWMay 7, 2026

Severe COPD biologic therapy class emerges past the inhaler era

Dupilumab COPD approval in eosinophilic phenotype, mepolizumab and benralizumab COPD pivotal data, and ensifentrine entry are reshaping severe COPD management.

TreatmentBiomarkersPipelineDrug development
SignalNEWMay 7, 2026

Soft tissue sarcoma therapy widens around fusion-defined biomarkers

NTRK inhibitor cross-tumour use, GIST line-of-therapy expansion, and emerging mechanism-targeted programs are reshaping soft tissue sarcoma management.

TreatmentBiomarkersPipelinePatient journey
SignalNEWMay 7, 2026

Cholangiocarcinoma targeted therapy widens past chemotherapy

FGFR2 inhibitor maturity, IDH1 inhibitor use, HER2-targeted therapy entry, and IO combinations are restructuring biliary tract cancer management.

TreatmentBiomarkersPipelineDrug development
SignalNEWMay 7, 2026

Chronic rhinosinusitis with nasal polyps biologic class matures

Dupilumab maturity, mepolizumab and benralizumab CRSwNP indications, omalizumab CRSwNP approval, and emerging mechanism programs are reshaping CRSwNP management.

TreatmentPatient journeyPipelineBiomarkers
SignalNEWMay 5, 2026

Glioblastoma therapy options evolve past temozolomide and TTFields

Tumour-treating fields maturity, IDH-mutant glioma vorasidenib approval, and emerging mechanism-targeted programs are reshaping glioma management.

TreatmentPipelineBiomarkersDrug development
SignalNEWMay 5, 2026

Neuromyelitis optica spectrum disorder therapy class competition matures

Eculizumab, ravulizumab, satralizumab, inebilizumab, and emerging mechanism programs define a competitive NMOSD prescribing landscape.

TreatmentBiomarkersPipelinePatient journey
SignalNEWMay 5, 2026

Chimeric autoantibody receptor T cells enter pemphigus vulgaris

Desmoglein 3-targeted CAART cell therapy programs in pemphigus vulgaris are reading out as a precision approach to autoantibody-driven disease.

TreatmentPipelineBiomarkersDrug development
SignalNEWMay 5, 2026

Colorectal cancer third-line and KRAS-targeted options widen

KRAS G12C-targeted programs, fruquintinib third-line use, and trastuzumab deruxtecan in HER2-amplified colorectal are restructuring late-line colorectal cancer.

TreatmentBiomarkersPipelinePatient journey
SignalNEWMay 5, 2026

Heart failure with reduced ejection fraction therapy moves beyond four-pillar standard

Vericiguat addition, mechanism-targeted programs, and emerging genetically-defined HFrEF approaches are reshaping the post-four-pillar landscape.

TreatmentPipelineBiomarkersDrug development
SignalNEWMay 5, 2026

Pediatric severe asthma biologic options expand

Dupilumab, mepolizumab, benralizumab, and tezepelumab paediatric label expansions plus emerging biologic programs are restructuring paediatric severe asthma.

TreatmentBiomarkersPipelinePatient journey
SignalNEWMay 4, 2026

Pre-eclampsia prediction and prevention infrastructure matures

sFlt-1 to PlGF ratio testing in suspected pre-eclampsia and aspirin-prophylaxis pathway adoption are reshaping pre-eclampsia care.

DiagnosisBiomarkersPatient journeyTreatment
SignalNEWMay 4, 2026

Gastric and gastroesophageal cancer therapy reshapes around HER2 maturity and claudin18.2 entry

Trastuzumab deruxtecan in HER2-low gastric, claudin18.2-targeted zolbetuximab approval, and IO combinations are restructuring upper GI oncology.

TreatmentBiomarkersPipelinePatient journey
SignalMay 2, 2026

Genetically-targeted Parkinson's programs reach pivotal data

LRRK2 inhibitors and GBA-targeted programs in Parkinson's disease are reading out as the first genetically-defined Parkinson's therapy options.

TreatmentPipelineBiomarkersDrug development
SignalApr 30, 2026

Concussion and TBI biomarker tools mature

Plasma GFAP and UCH-L1 assays for concussion and traumatic brain injury are establishing routine emergency-department use.

DiagnosisBiomarkersInfrastructure
SignalApr 30, 2026

Choroidal melanoma therapy options widen

Approved tebentafusp and emerging programs are creating the first systemic therapy options for metastatic choroidal melanoma.

TreatmentPipelineBiomarkersDrug development
SignalApr 28, 2026FDA · peer-reviewed · specialty-lab

Plasma biomarker testing is displacing amyloid PET as the screening modality for anti-amyloid eligibility

Three FDA-cleared blood tests for amyloid pathology are now in routine use at major Alzheimer's centres, materially reducing the amyloid-PET demand that constrained early lecanemab uptake.

DiagnosisBiomarkersAccessScreening
SignalApr 26, 2026registry · peer-reviewed

Tezepelumab uptake in type-2-low severe asthma is the field's defining commercial test

Tezepelumab's upstream mechanism (anti-TSLP) reaches patients in the type-2-low phenotype that the downstream biologic class cannot effectively serve. Real-world commercial uptake in this previously underserved population is the test of whether the upstream-mechanism advantage translates from clinical evidence to commercial reality.

TreatmentBiomarkers
SignalApr 26, 2026peer-reviewed · specialty-lab

Parkinson's biomarker work is converging on the alpha-synuclein seed-amplification assay

The alpha-synuclein seed-amplification assay (alpha-syn-SAA) has emerged as the leading biomarker for Parkinson's disease and adjacent synucleinopathies. The assay's sensitivity, specificity, and the implications for both diagnosis and trial-enrolment are material.

BiomarkersDiagnosis
SignalApr 26, 2026peer-reviewed · conference

KRAS G12C resistance patterns are reshaping second-line NSCLC sequencing

Resistance mechanisms emerging from sotorasib and adagrasib post-progression sampling are converging on a finite set of pathways. The implications for second-line decision-making and combination design are starting to land in clinic.

PipelineBiomarkersLung cancerSequencing
SignalApr 26, 2026conference · industry-filing

TROP2 ADC class read-throughs from Q1 2026 readouts

The TROP2 antibody-drug conjugate class has multiple late-stage assets reading out in overlapping breast cancer and NSCLC populations. Q1 2026 readouts have started to differentiate the class on toxicity profile and biomarker dependency rather than on bulk efficacy.

PipelineBiomarkersBreast cancerLung cancer
SignalApr 26, 2026FDA · peer-reviewed · conference

Antibody-drug conjugates are reshaping the HER2-low breast cancer setting

T-DXd's expansion into HER2-low has changed second-line decision-making, and the ADC class is delivering further candidates that are likely to redefine biomarker-driven sequencing across breast cancer subtypes.

TreatmentPipelineBiomarkersDrug development
SignalApr 23, 2026CMS · peer-reviewed · industry-filing · health-system

Tau PET reimbursement is the next diagnostic access question

Amyloid PET has settled into routine coverage and availability. Tau PET - which will be the confirmatory pathway for tau-directed therapies - is sited at meaningfully fewer centers and reimbursed unevenly. The access conversation that defined anti-amyloid rollout is about to repeat, one mechanism later.

AccessDiagnosisBiomarkersPipeline
SignalApr 23, 2026registry · peer-reviewed · health-system

Real-world ARIA rates from registries are landing close to trial estimates

Early registry data on lecanemab and donanemab in routine clinical use is producing ARIA incidence numbers that broadly track the pivotal trials, with APOE4 homozygotes consistently the highest-risk group.

SafetyBiomarkersAccessGenetics
SignalApr 21, 2026peer-reviewed · conference · expert-interview

Co-pathology recognition is reshaping how Alzheimer's diagnosis is being read

LATE, vascular contribution, and Lewy-body co-pathology are now routinely on the differential when a patient with cognitive symptoms tests amyloid-positive. The clinical question is increasingly "what mix" rather than "is it Alzheimer's."

DiagnosisBiomarkersPipeline
SignalApr 21, 2026peer-reviewed · specialty-lab · health-system

Plasma-biomarker rollout is concentrated at academic centers

Adoption of plasma p-tau217 testing remains concentrated at academic medical centers and large specialty practices, with community uptake meaningfully behind.

DiagnosisBiomarkersAccessInfrastructure
SignalApr 15, 2026industry-filing · specialty-lab · peer-reviewed

Blood-based biomarkers move from research to clinical workflow

Plasma p-tau217 assays are being adopted as a triage step before PET or CSF confirmation in specialty memory clinics.

DiagnosisBiomarkers

Snapshots

13
SnapshotNEWMay 8, 2026

Thyroid cancer therapy reference (2026)

Reference snapshot of thyroid cancer therapy across differentiated, medullary, and anaplastic subtypes.

TreatmentBiomarkersPatient journey
SnapshotNEWMay 8, 2026

Dementia subtype therapy reference (2026)

Reference snapshot of dementia therapy across Alzheimer's, dementia with Lewy bodies, vascular, and frontotemporal subtypes.

DiagnosisTreatmentBiomarkersPatient journey
SnapshotNEWMay 8, 2026

Allergic bronchopulmonary aspergillosis therapy reference (2026)

Reference snapshot of ABPA therapy across acute, recurrent, and emerging biologic-integrated tiers.

TreatmentBiomarkersDiagnosisPatient journey
SnapshotNEWMay 7, 2026

Cholangiocarcinoma therapy reference (2026)

Reference snapshot of cholangiocarcinoma therapy across resectable and advanced disease and biomarker-defined targeted tiers.

TreatmentBiomarkersPatient journey
SnapshotNEWMay 7, 2026

ANCA-associated vasculitis therapy reference (2026)

Reference snapshot of ANCA-associated vasculitis therapy across induction, maintenance, and refractory disease.

TreatmentBiomarkersPatient journey
SnapshotNEWMay 7, 2026

Lipid management therapy reference (2026)

Reference snapshot of lipid management therapy across foundational, add-on, and emerging tiers.

TreatmentBiomarkersDelivery
SnapshotNEWMay 7, 2026

Severe COPD therapy reference (2026)

Reference snapshot of severe COPD therapy across foundational inhaler, biologic, and emerging mechanism tiers.

TreatmentBiomarkersPatient journey
SnapshotNEWMay 5, 2026

Lupus nephritis therapy reference (2026)

Reference snapshot of lupus nephritis therapy across induction and maintenance phases.

TreatmentBiomarkersPatient journey
SnapshotNEWMay 5, 2026

HFrEF therapy reference (2026)

Reference snapshot of HFrEF therapy across the four-pillar standard, additional approved options, and emerging mechanism classes.

TreatmentBiomarkersPatient journey
SnapshotNEWMay 5, 2026

Adult diffuse glioma therapy reference (2026)

Reference snapshot of adult diffuse glioma therapy across IDH-mutant grade 2/3 disease, glioblastoma first-line, and recurrent disease.

TreatmentBiomarkersPatient journey
SnapshotApr 24, 2026clinical-trial · FDA · CMS · EMA · NICE · peer-reviewed · industry-filing

What we are watching in Alzheimer's, as of Q2 2026

A reference list of the threads PatientSpotlight is actively tracking - clinical readouts, regulatory and reimbursement decisions, real-world evidence accumulation, and operational rollout. Each thread names what to watch and why it matters, without predicting when it will resolve.

Drug developmentRegulatoryAccessPipeline
SnapshotUpdated Apr 24, 2026peer-reviewed · FDA · clinical-trial

Clinical trial endpoints in Alzheimer's disease, as of Q2 2026

A reference view of the cognitive, functional, and biomarker endpoints used in late-stage Alzheimer's trials - what each measures and how to read a readout that uses it.

Drug developmentRegulatoryBiomarkers
SnapshotUpdated Apr 24, 2026FDA · conference · specialty-lab

Alzheimer's diagnostic pathways, as of Q2 2026

Plasma biomarkers are entering routine workflows alongside established CSF and PET options, with confirmatory imaging still standard before disease-modifying therapy.

DiagnosisBiomarkers

Explained

9
ExplainedApr 26, 2026peer-reviewed

Preeclampsia screening: where biomarker-based pathways are converting

Preeclampsia screening has moved from clinical-risk-factor-driven to biomarker-augmented pathways in several markets. The methodology, the access frame, and the implications for both maternal outcomes and commercial planning around adjacent assets are worth understanding.

DiagnosisBiomarkersAccess
ExplainedApr 26, 2026peer-reviewed · specialty-lab

ctDNA-guided treatment decisions are entering routine oncology care

Circulating tumour DNA testing has moved from research-grade tool to a routine decision aid in several oncology indications. The pathways from blood draw to clinical decision are now described well enough to plan around, even though reimbursement remains uneven.

BiomarkersDiagnosisAccess
ExplainedApr 26, 2026FDA · EMA · HTA-bodies

Why 'tumor-agnostic' approvals are reshaping reimbursement reviews

When a drug is approved for a molecular target across tumor types rather than for one cancer, the HTA review framework has to evaluate efficacy across heterogeneous indications with different unmet needs, comparators, and standard-of-care benchmarks. That has practical consequences for access timelines.

RegulatoryReimbursementTumor agnosticAccess
ExplainedApr 26, 2026peer-reviewed · FDA · guideline-bodies

COPD's biomarker problem and how the field is solving it

COPD has, until recently, been managed as a single condition with a stepwise pharmacological ladder. The arrival of biologics in COPD - and the subgroup-driven trial designs that supported their approval - has forced the field to confront a biomarker question that asthma resolved a decade ago: which patient, which mechanism, which therapy, and how do we know.

CopdBiomarkersBiologicsEosinophils
ExplainedApr 24, 2026peer-reviewed · regulatory-body · specialty-lab

What are CSF biomarkers, and how do they fit alongside plasma and PET?

CSF biomarkers - measured in cerebrospinal fluid obtained by lumbar puncture - are well-validated tests for Alzheimer's pathology that pre-date both plasma biomarkers and broad amyloid PET access. They remain in routine clinical use, particularly where PET is not available and where the diagnostic question is complex enough to warrant the procedural friction.

DiagnosisBiomarkersPatient journey
ExplainedApr 24, 2026peer-reviewed · regulatory-body · CMS

What is tau PET, and how is it different from amyloid PET?

Tau PET is a brain scan that shows the build-up of tau, the second protein associated with Alzheimer's disease. The image is closer to the clinical picture than amyloid is - tau accumulation tracks more directly with where and how a person is currently impaired. The trade-off is that tau PET is harder to access than amyloid PET, and the access gap is now a rate-limiter on multiple fronts.

DiagnosisBiomarkersPatient journeyAccess
ExplainedApr 23, 2026peer-reviewed · regulatory-body · expert-interview

What is co-pathology in dementia, and why does it matter?

Co-pathology means more than one disease process is contributing to someone's symptoms at the same time. In older patients with cognitive symptoms, mixed pathology is the rule, not the exception.

DiagnosisBiomarkersPatient journey
ExplainedApr 22, 2026peer-reviewed · regulatory-body · CMS

What is amyloid PET, and when is it used?

Amyloid PET is a brain scan that shows whether the amyloid protein associated with Alzheimer's disease has built up in the brain. It is used to confirm or rule out Alzheimer's pathology when the diagnosis matters.

DiagnosisBiomarkersPatient journey
ExplainedApr 22, 2026peer-reviewed · regulatory-body · specialty-lab

What are plasma biomarkers in Alzheimer's disease?

Plasma biomarkers are blood tests that look for proteins associated with Alzheimer's disease pathology. The most clinically useful one in 2026 is plasma p-tau217.

DiagnosisBiomarkersPatient journey