What Is Diagnostic Repurposing in IVD and CDx?
Diagnostic repurposing in IVD and CDx means reusing an already validated assay, biomarker panel, or analytical platform for a new indication, disease area, or care setting. Instead of building a test from scratch, manufacturers extend proven NGS, qPCR, dPCR, immunoassay, or AI pipelines and generate focused bridging evidence to satisfy FDA, IVDR, UKCA, and payer requirements.
In the era of precision medicine, in vitro diagnostics (IVDs) and companion diagnostics (CDx) are no longer single-use tools tied to one disease or one drug. They are repeatable scientific platforms that can be extended, adapted, and redeployed across multiple indications.
Diagnostic repurposing means taking an already validated assay, biomarker panel, or analytical platform and using it for a new clinical question, disease area, or care setting. Instead of building a completely new test from scratch, manufacturers reuse proven NGS, qPCR, dPCR, immunoassay, or AI pipelines – and generate focused bridging data to support the new indication.
In the era of precision medicine, in vitro diagnostics (IVDs) and companion diagnostics (CDx) are no longer single-use tools tied to one disease or one drug. They are configurable scientific platforms that can be extended, adapted, and redeployed across multiple clinical indications.
Diagnostic repurposing means taking an already validated assay, biomarker panel, or analytical platform and using it to answer a new clinical question, in a new disease area or care setting. Instead of building a completely new test from scratch, manufacturers:
- reuse proven NGS, qPCR, dPCR, immunoassay, or AI pipelines, and
- generate focused bridging analytical, clinical, and real-world evidence to support the new indication.
Done well, diagnostic repurposing delivers exactly what payers and HTA bodies care about most:
- Speed – faster time from concept to clinical use because analytical validity already exists.
- Cost-efficiency – lower development and evidence-generation cost per indication.
- Reimbursement readiness – cleaner alignment with FDA, IVDR, MHRA/UKCA, CMS, NICE, HAS, and G-BA expectations.
Whether it is adapting a sepsis gene-expression signature to predict COVID-19 severity, or extending an oncology CDx (KRAS, MSI-H, TMB) to additional tumour types, repurposing turns one IVD platform into a multi-indication, multi-revenue asset.
At Odelle Technology, we sit precisely at the interface between biology, regulation, and reimbursement—making sure repurposed diagnostics are not only scientifically credible, but also correctly coded, priced, and reimbursed in the USA, France, Germany, and the UK.
Done well, diagnostic repurposing delivers three things payers care about most:
- Speed – faster time from concept to clinical use because analytical validity already exists.
- Cost-efficiency – lower development and evidence costs per indication.
- Reimbursement readiness – cleaner alignment with FDA, IVDR, MHRA/UKCA, and HTA expectations.
Whether it is adapting a sepsis gene-expression signature to predict COVID-19 severity, or extending an oncology CDx (KRAS, MSI-H, TMB) to new tumour types, repurposing turns one IVD platform into a multi-indication, multi-revenue asset. At Odelle Technology, we focus specifically on this interface between biology, regulation, and reimbursement – making sure that repurposed diagnostics are not only scientifically credible, but also coded, priced, and reimbursed in the USA, France, Germany, and the UK.
The Science Behind Diagnostic Repurposing
Diagnostic repurposing sits at the intersection of systems biology, multi-omics, and precision medicine. It starts from a simple observation: many biological pathways and biomarkers are conserved across apparently different diseases.
- Oncogenic pathways such as KRAS mutations, once confined to colorectal cancer, now guide targeted therapy in NSCLC, pancreatic cancer, and endometrial tumours.
- Host-immune response genes (e.g. IL-6, CD64, HLA-DR) recur across sepsis, viral infection, trauma, and ICU deterioration – enabling host-response panels to be redeployed in new critical-care settings.
- Genomic instability markers such as MSI-H and TMB span Lynch-syndrome malignancies and other solid tumours, supporting pan-tumour CDx indications.
Because the wet-lab platforms (NGS, dPCR, IHC, multiplex PCR) are already validated, much of the work involved in repurposing is:
- re-training or re-calibrating the bioinformatics and AI models,
- generating bridging analytical and clinical data for the new population or specimen type, and
- updating the intended use, labelling, and Performance Evaluation Report (PER) under FDA, IVDR, UKCA, and local HTA rules.
This scientific elasticity shortens development cycles, reduces risk, and creates a much stronger story for payers: one platform, multiple indications, shared infrastructure, and measurable system savings.
Global Reimbursement Landscape for Repurposed Diagnostics
The table below summarises how repurposed IVDs and CDx typically gain or extend reimbursement in key markets:
Global Reimbursement Landscape — Repurposed Diagnostics (2025)
United States – CMS, CPT and PLA Codes
Repurposed assays enter the US reimbursement system through a combination of CPT/PLA coding and Medicare coverage:
- CPT / PLA codes (AMA):
- Apply for a new PLA code or adapt existing CPT coding if the assay’s intended use, analytes, or algorithm have changed.
- Ensure the code descriptor matches the new indication (e.g., additional tumour type, new risk score, new matrix).
- CMS coverage (LCD/NCD):
- Medicare Administrative Contractors (MACs) issue Local Coverage Determinations (LCDs) based on clinical-utility evidence in the new indication.
- Positive LCDs can later underpin National Coverage Determinations (NCDs) and influence private payers.
- Economic expectations:
- Budget impact models showing reduced hospitalisations, ICU days, or ineffective therapy.
- RWE from CLIA laboratories demonstrating that test use changes clinical decisions and outcomes.
For repurposed tests, the key is alignment: FDA label, PLA/CPT code, and LCD wording must all describe the same intended use and population.
Germany – NUB Antrag, ZE and EBM/DRG Integration
In Germany, repurposed diagnostics often start as hospital innovations before being embedded in national tariffs:
- NUB Antrag (§6 KHEntgG):
- Annual application (by 31 October) to InEK for Neue Untersuchungs- und Behandlungsmethoden.
- Suitable for repurposed sepsis panels, oncology NGS, or AI-assisted diagnostics that do not yet sit comfortably in existing DRGs.
- Requires a clear innovation description, analytical and clinical evidence, and an economic rationale (e.g., ICU length-of-stay reduction, antibiotic savings).
- ZE (Zusatzentgelt):
- Once multiple hospitals use the technology, a ZE supplemental payment can standardise reimbursement nationally while DRG updates are in progress.
- EBM and outpatient use:
- For outpatient deployment, inclusion in the EBM catalogue requires a G-BA decision based on IQWiG’s assessment of clinical and economic benefit.
- Long-term integration:
- When cost-effectiveness is established, InEK integrates the procedure into standard DRGs and assigns specific OPS codes, creating sustainable reimbursement.
Repurposed diagnostics therefore follow a staged path: NUB → ZE → DRG/EBM, supported by robust RWE from German university hospitals and AMR or oncology networks.
France – LPPR, RIHN 2.0 and Health-Economic Evaluation
France links reimbursement for repurposed diagnostics tightly to clinical value and medico-economic evidence:
- LPPR listing:
- All reimbursable IVDs and CDx must be on the Liste des Produits et Prestations Remboursables (LPPR).
- Repurposed tests submit an updated dossier to HAS/CNEDiMTS, demonstrating that the Service Attendu (SA) and Amélioration du Service Attendu (ASA) remain positive in the new indication.
- RIHN 2.0 (conditional coverage):
- Innovative or high-uncertainty diagnostics can obtain temporary reimbursement while generating RWE, particularly relevant for expanded indications or digital/AI-driven tests.
- Economic requirements:
- Cost-Utility Analysis (CUA) with ICER estimates (€/QALY) compared with current diagnostic practice.
- Budget Impact Analysis (BIA) for CNAM, reflecting prevalence, uptake, and downstream treatment effects.
- Sensitivity analyses addressing uncertainty in test performance, care pathway changes, and cost inputs.
- Lifecycle management:
- HAS reassesses LPPR entries approximately every five years, allowing CEPS to revise price based on new clinical and economic data.
- Strong post-market RWE and PMCF are therefore central to maintaining reimbursement for repurposed diagnostics.
For repurposed IVDs, France rewards technologies that demonstrate better outcomes, better organisation of care, and credible savings within GHT/ARS networks.
United Kingdom – NICE HTE and NHS Adoption Pathways
In the UK, repurposed IVDs and CDx must align with both MHRA/UKCA regulation and NICE health-economic expectations:
- NICE HealthTech Evaluation (HTE):
- The main route for non-drug technologies, including diagnostics, AI and digital tools.
- Particularly relevant when an existing platform is extended to new tumour types, care settings, or risk groups.
- Emphasises cost-consequence and budget impact over pure ICER estimation.
- Diagnostics Assessment Programme (DAP):
- Used when the repurposed diagnostic directly determines therapy choice or NHS pathway design (e.g., companion diagnostics, stratification tests).
- Funding levers:
- Positive NICE guidance can trigger access to the MedTech Funding Mandate or support adoption via the NHS Innovation Service and regional ICS budgets.
- Economic focus:
- Demonstrate impact on time-to-treatment, avoidable admissions, theatre/ICU throughput, and workforce efficiency.
- Use cost-consequence and scenario analyses tailored to NHS Payment Scheme flows.
The most successful repurposing dossiers show NHS-specific operational value: fewer delayed discharges, better antimicrobial stewardship, or more efficient use of specialist services.
European Union (Cross-Market) – EU HTA and Pan-EU RWE
From 2025 onwards, the EU HTA Regulation gradually introduces Joint Clinical Assessment (JCA) for certain diagnostics and high-impact technologies:
- JCA for diagnostics:
- Allows manufacturers to submit one core clinical-evidence package to support HTA in multiple Member States.
- National bodies (HAS, G-BA, AEMPS, ZIN, AIFA, etc.) still make local pricing and reimbursement decisions, but share a common evidence base.
- Pan-EU RWE infrastructure:
- Networks such as DARWIN EU and EHDEN enable federated analyses of real-world data, increasingly relevant for repurposed diagnostics seeking multi-country recognition.
- Strategy for repurposing:
- Maintain a single evidence spine (analytical validity, pivotal studies, PER, RWE) and adapt country annexes for local tariffs, coding and HTA rules.
For repurposed IVDs, EU HTA is less about replacing national processes and more about making one strong, reusable evidence core go further.
Strategic Evidence Requirements for Diagnostic Repurposing
Across all markets, payers and HTA bodies converge on five recurring evidence questions:
- Incremental Clinical Value
- How does the repurposed diagnostic change decision-making compared with current practice?
- Typical endpoints: time-to-targeted therapy, reduction in unnecessary treatment, earlier escalation or de-escalation, ICU/LOS reduction, survival or QALY impact.
- Real-World Evidence (RWE) in the New Indication
- Multi-centre registries, LIS-linked datasets, or pragmatic trials demonstrating performance and decision impact in routine care.
- Ideally, data from at least 3–5 centres and from the health system where reimbursement is sought (e.g., NHS trusts, German university hospitals, French CHU/GHT networks).
- Economic Modelling and Budget Impact
- Cost-consequence and budget impact analyses are usually more influential for diagnostics than pure ICERs.
- Show which cost buckets move: test costs, length of stay, readmissions, antibiotic days, drug wastage, adverse events.
- Comparator Selection and Local Pathways
- Comparators must reflect real local practice, not just global best-case scenarios: culture vs molecular testing, existing AI, current triage rules.
- HTA bodies will challenge any mismatch between the model and how patients are actually managed today.
- Lifecycle Evidence and Reassessment
- Plan for post-market follow-up (PMCF), RWE updates and periodic reassessment (e.g., LPPR 5-year reviews, LCD renewals, NICE surveillance).
- Repurposed diagnostics need a living evidence plan, not a one-off dossier.
Diagnostic repurposing is no longer a speculative tactic—it is the most capital-efficient way to scale precision medicine. By extending IVDR-compliant, FDA-cleared, or UKCA-marked platforms into new indications, manufacturers can grow revenue, de-risk pipelines, and meet payer expectations without restarting development from zero each time.
The formula is simple but demanding:
- Speed – connect existing analytical validity to new claims through smart PER updates, Article 48 consultations, PMA supplements, De Novo or 510(k) strategies.
- Evidence – link biology to outcomes using pragmatic RWE (antibiotic-day reduction, time-to-therapy, ICU length of stay, QALYs) that HTA bodies explicitly reward.
- Access – translate proof into payment through LPPR/RIHN (France), NUB/ZE/EBM (Germany), NICE HTE/DAP and UKCA (UK), CPT/PLA + LCD/NCD (USA).
- Economics – show multi-indication value with ICER, BIA, CCA and NMB models grounded in real care pathways and local tariffs.
The winners will be those who treat their assay as a platform: map biological overlap, prioritise high-yield indications, run lean bridging studies, and package the results in payer-ready economics. This is how FoundationOne® CDx became pan-tumour, how SeptiCyte® RAPID adapted during the pandemic, and how your own pipeline can move from single-use to system-wide impact.
Glossary of Key Terms
Diagnostic Repurposing—Scientific, Regulatory, and Health-Economic Reference (2025)
A–B
Analytical Validity (Assay Performance)
Analytical Validity (Assay Performance) demonstrates the accuracy and reliability with which an IVD measures its intended biomarker.
Core parameters: sensitivity, specificity, linearity, limit of detection (LOD), and precision (CV%).
Why it matters: Establishes the scientific foundation for diagnostic repurposing by confirming reproducibility in the new clinical setting.
Regulatory references: FDA Analytical Validation Guidance; EU IVDR Annex I, Article 56.
SEO Keywords: assay reproducibility, analytical performance validation, diagnostic precision metrics.
Article 48 (EU IVDR)—CDx Scientific Opinion
Under EU Regulation 2017/746, Notified Bodies must obtain a scientific opinion from the EMA or relevant National Competent Authority (NCA) for all companion diagnostics (CDx). This ensures alignment between the diagnostic’s claimed indication and the therapeutic label.
Reference: European Commission – IVDR Article 48 Guidance
BIA — Budget Impact Analysis (Payer Economics)
Estimates the short-term financial consequences of adopting a diagnostic within a healthcare system.
Formula:
BIA = (Cₙₑw × Nₙₑw) − (Cₒld × Nₒld)
where C = cost per patient and N = treated population.
Purpose: Quantifies affordability and cash-flow impact; often used by HAS (France), NICE (UK), ZIN (Netherlands), and CMS (USA).
SEO Keywords: payer modelling, CNAM budget impact, NHS tariff forecasting.
C–D
CDx — Companion Diagnostic (Therapy Selection)
An IVD that identifies patients likely to benefit from or be harmed by a specific therapy (e.g., KRAS, EGFR, ESR1, MSI-H).
Authorities: FDA Companion Diagnostics | EMA Overview
CE Marking (EU IVDR) — Conformity
Indicates that a diagnostic meets essential safety, performance, and clinical-evidence requirements under Regulation (EU) 2017/746.
Access to the EU market is mandatory for all devices, and their classification ranges from Class A to D, with Companion Diagnostics (CDx) typically classified as Class C.
SEO Keywords: IVDR compliance, CE-marked diagnostics, Notified Body conformity.
Clinical Outcome Impact
Evaluates how much a diagnostic helps in managing patients and improving their health, such as longer survival without disease, shorter stays in the ICU, fewer days on antibiotics, and quicker access to the right
Use: It supports real-world evidence and health-economic modelling.
CUA — Cost-Utility Analysis (Cost-Effectiveness)
Evaluates value for money in terms of cost per Quality-Adjusted Life Year (QALY) gained.
ICER = (Cₙₑw − C₍cₒmp₎) / (QALYₙₑw − QALY₍cₒmp₎)
Thresholds: UK ≈ £20–30k/QALY; France ≈ €50k/QALY (implicit).
SEO Keywords: QALY modelling, ICER analysis, diagnostic cost-utility.
CNEDiMTS/ HAS (France)
The HAS sub-committee is responsible for evaluating Service Attendu (SA) and Amélioration du Service Attendu (ASA) to determine the LPPR listing of medical devices and diagnostics.
Reference: HAS CNEDiMTS Portal
E–F
EBM (Germany) — Outpatient Reimbursement
The Einheitlicher Bewertungsmaßstab defines fee-for-service tariffs for diagnostics in ambulatory care.
Maintained by: KBV
SEO Keywords: EBM codes, German outpatient diagnostics, GKV reimbursement.
EUDAMED (EU)—Device Database.
Comprehensive database covering registration, UDI, certificates, vigilance, and market surveillance for all devices and IVDs.
Portal: EUDAMED
FDA 510(k) Clearance — Substantial Equivalence
The US regulatory pathway demonstrates that a device is substantially equivalent to a legally marketed predicate.
This clearance is crucial for the repurposing of diagnostics, as it allows the use of existing technology to develop new biomarkers or indications.
Database: FDA 510(k)
G–I
G-BA (Germany) — Coverage Decisions
Germany’s top decision-making body for inclusion/exclusion in statutory health insurance (GKV).
Informed by: IQWiG benefit assessments.
Website: G-BA.de
HTA — Health Technology Assessment
Systematic evaluation of the clinical, economic, organisational, and ethical dimensions of health technologies.
Key agencies: NICE (UK), HAS (FR), IQWiG (DE), TLV (SE), ZIN (NL), KCE (BE).
SEO Keywords: diagnostic HTA, evidence appraisal, cost-effectiveness modelling.
ICER — Incremental Cost-Effectiveness Ratio
Central economic KPI expressing additional cost per additional health gain (e.g., per QALY).
SEO Keywords: ICER modelling, economic evaluation, cost-effectiveness threshold.
IQWiG (Germany) — Benefit Assessment
IQWiG (Germany) publishes methodological standards and conducts evidence appraisals to guide G-BA decisions.
Reference: IQWiG Methods Paper 2023
IVD—Invitro Diagnostic
Diagnostic tests performed on biological samples outside the human body for detection, stratification, or monitoring of disease.
Regulated by: FDA (21 CFR 809) and EU IVDR.
IVDR (EU 2017/746)—Regulation
Replaces the IVDD; enforces Performance Evaluation Reports (PER), Post-Market Clinical Follow-up (PMCF), PSUR, UDI, and robust Notified Body oversight.
Official text: EUR-Lex IVDR
L–N
LCD — Local Coverage Determination (US Medicare)
Regional CMS decisions defining coverage for diagnostics prior to national rollout.
Resource: CMS LCD Database
LDT — Laboratory-Developed Test (CLIA Context)
In-house assays developed by CLIA-certified laboratories are currently under evolving FDA oversight (2025 rule proposed).
SEO Keywords: LDT regulation, CLIA compliance, FDA harmonisation.
LPPR (France) — List of Reimbursable Products and Services
The official reimbursement list for medical devices and diagnostics.
Evaluated by HAS/CNEDiMTS, priced by CEPS.
Portal: LPPR Database
MHRA (UK) — Medical Device Regulator
Oversees UKCA marking, vigilance, sandboxes, and AIaMD guidance post-Brexit.
Site: MHRA Devices
NUB Antrag / ZE (Germany) — Hospital Innovation Funding
- NUB Antrag: annual application for new or repurposed diagnostics seeking temporary reimbursement.
- ZE (Zusatzentgelt): negotiated supplement bridging to permanent DRG inclusion.
Reference: InEK NUB Portal
NICE (UK) — HealthTech Evaluation (HTE) / DAP
- HTE: streamlined evaluation for non-pharmaceutical tech (e.g., diagnostics, digital tools).
- DAP: diagnostics influencing therapy selection.
Portal: NICE HealthTech
O–P
OPS (Germany) — Inpatient Coding
Procedural coding is used for DRG grouping and tariff calculation.
Maintained by BfArM / DIMDI.
PER — Performance Evaluation Report (IVDR Core)
Central IVDR document integrating scientific validity, analytical, and clinical performance.
Must be continuously updated under Annex XIII.
PMA (FDA) — Premarket Approval
Highest US regulatory pathway (Class III), typically required for CDx linked to drug labels. May involve coordinated drug–diagnostic submissions.
PMS / PMCF / PSUR — Lifecycle Evidence
- PMS: ongoing post-market surveillance.
- PMCF: post-market clinical follow-up studies.
- PSUR: periodic safety update reports (Class C/D IVDs).
PLA Code (US AMA CPT)
Proprietary Laboratory Analysis codes identify brand-specific assays for reimbursement.
Directory: AMA PLA Codes
Q–R
QALY — Quality-Adjusted Life Year
Composite measure combining quantity and quality of life (utility 0–1). Used in CUA and ICER analyses.
RWE / RWD — Real-World Evidence / Data
Real-world evidence is created by analysing actual data from sources like electronic health records, registries, claims, and biobanks to support health technology assessments
SEO Keywords: pragmatic trials, observational evidence, post-market RWE, lifecycle HTA.
Regulatory Sandbox (UK MHRA)
Controlled environment for testing innovative IVDs or AI algorithms pre-market with supervisory oversight.
S–T
SA / ASA (France) — Clinical Value Grades
- SA (Service Attendu): baseline clinical benefit.
- ASA (Amélioration du Service Attendu): incremental added benefit.
Grades I–V determine LPPR pricing by CEPS.
TMB — Tumour Mutational Burden (Immunotherapy Biomarker)
Mutations per megabase (Mb) are used as predictive markers for immunotherapy response. Common in pan-tumour CDx development.
Therascreen® KRAS RGQ PCR Kit (QIAGEN)
Example of diagnostic repurposing—initially for colorectal cancer, later validated for NSCLC G12C mutations. Demonstrates assay expansion to multiple indications.
U–Z
UDI — Unique Device Identifier
Standardised traceability system for device/IVD tracking throughout the supply chain and post-market surveillance.
UKCA Mark (Great Britain) — Conformity
Post-Brexit marking replacing CE in the UK. Transition period to mid-2025; includes reliance and enhanced PMS mechanisms.
VBHC — Value-Based Healthcare
Payment and evaluation model linking reimbursement to patient outcomes and system efficiency. Diagnostics contribute via time-to-right-therapy and resource optimisation.
ZE (Zusatzentgelt, Germany) — Supplemental Tariff
Temporary hospital payment for innovative diagnostics pending full DRG inclusion; often follows successful NUB Antrag.
Authoritative Agencies & Databases Repurpose validated IVD/CDx devices to generate revenue from multiple indications.
| Agency / Database | Jurisdiction | Function | Official Link |
|---|---|---|---|
| FDA — CDRH | USA | 510(k), PMA, De Novo | fda.gov/medical-devices |
| CMS | USA | Coding, coverage, LCD/NCD | cms.gov |
| EMA | EU | CDx Art. 48 opinions | ema.europa.eu |
| European Commission — IVDR | EU | Legislation & guidance | health.ec.europa.eu |
| HAS / CNEDiMTS / CEPS | France | Clinical & economic evaluation; pricing | has-sante.fr |
| CNAM (Ameli) | France | National payer & LPPR | ameli.fr |
| InEK | Germany | DRG, NUB, ZE | g-drg.de |
| IQWiG | Germany | Benefit/economic assessment | iqwig.de |
| G-BA | Germany | Coverage & guidelines | g-ba.de |
| MHRA | UK | UKCA, PMS, vigilance | gov.uk/mhra |
| NICE | UK | HTE & DAP | nice.org.uk |
| BIVDA | UK | IVD industry body | bivda.org.uk |
Key Economic & Modelling Formulae
| Concept | Formula | Interpretation |
|---|---|---|
| ICER | ICER = (C_new − C_old) / (E_new − E_old) | Cost per additional unit of effect (e.g., QALY). |
| BIA | ΔBudget = (N_new × C_new) − (N_old × C_old) | Short-term payer budget impact. |
| NMB | NMB = (E × λ) − C | Monetises effect at a given willingness-to-pay (λ). |
| ROI | ROI = (Savings − Costs) / Costs | Economic efficiency of adoption. |
| QALY | QALY = Σ (Utility_t × Time_t) | Combines survival and health-state utility (0–1). |
SEO Tip: Use anchors (e.g.,) inside your article body to deep-link into this glossary and boost internal link equity for priority keywords (IVDR Article 48, LPPR France, NUB Antrag Germany, NICE HTE, FDA 510(k), UKCA).
Repurpose validated IVD/CDx to new indications. Win IVDR/FDA approval, generate RWE, and secure LPPR, NUB, NICE, and LCD reimbursement.
stagnation or growth – your choice. Without repurposing, your portfolio will shrink
Diagnostic repurposing is no longer a speculative tactic—it’s the most capital-efficient way to scale precision medicine. By leveraging IVDR-compliant platforms, FDA 510(k)/PMA routes, and lifecycle RWE, manufacturers can extend a single validated assay across multiple indications and care settings—without restarting development from zero.
- To increase speed, connect analytics and claims using PER updates, Article 48 consultations, and predicate-based FDA strategies.
- Evidence: link biology to outcomes via pragmatic RWE (antibiotic-day reduction, time-to-therapy, ICU LOS) that HTA bodies reward.
- Access: translate proof into payment through LPPR (France), NUB/ZE (Germany), NICE HTE/DAP (UK), and LCD/CPT/PLA (USA).
- Economics: demonstrate value with ICER, BIA, and NMB—showing how one platform delivers multi-indication ROI.
The winners will be those who treat their assay as a platform: map biological overlap, prioritise high-yield indications, run lean bridging studies, and package the results in payer-ready economics. This illustrates how FoundationOne® became pan-tumour, how SeptiCyte® adapted during the pandemic, and how your pipeline can increase value.
Odelle Technology works with IVD and CDx teams to handle everything from scientific mapping and meeting regulations to creating models that meet health technology assessment standards and helping with real-world use in the USA, France, Germany If you’re ready to repurpose with purpose, we’ll get you from analytical validity to reimbursed clinical reality.
Explore the full glossary (IVDR, PER, LPPR, NUB, NICE, LCD)Book a repurposing strategy callSee case studies in oncology, sepsis, and critical care
Reference List
FDA (2018). In Vitro Companion Diagnostic Devices: Guidance for Industry and FDA Staff.
This guidance sets out FDA expectations for development, analytical validation, clinical validation, labelling, and regulatory pathways for companion diagnostics (CDx) linked to targeted therapies.
Available at: https://www.federalregister.gov/documents/2018/12/07/2018-26554/developing-and-labeling-in-vitro-companion-diagnostic-devices-for-a-specific-group-or-class-of
European Commission (2017). Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).
The core regulatory framework governing clinical evidence, performance evaluation, companion diagnostics, economic operators, and post-market surveillance across the EU.
Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746
MHRA (2024). Implementation of the Future Regulation of Medical Devices. UK Government Regulatory Roadmap.
Provides the UK’s phased strategy for post-Brexit device regulation, including requirements for IVDs, CDx, software/AI devices, and international alignment.
Available at: https://assets.publishing.service.gov.uk/media/6759a8827e419d6e07ce2b21/Med_Tech_Regulatory_Roadmap_V2_December_2024.pdf
Foundation Medicine (2023). FoundationOne® CDx Technical Summary. Roche Diagnostics.
Describes the analytical and clinical performance of the FDA-approved pan-tumour comprehensive genomic profiling CDx assay used to guide targeted oncology therapies.
Available by search (official links vary by region):
https://www.foundationmedicine.com/test/foundationone-cdx
QIAGEN (2023). therascreen® KRAS RGQ PCR Kit—Product Insert.
Official IFU detailing sample handling, KRAS mutation detection methods, performance characteristics and intended clinical use in guiding targeted treatment selection.
Available at: https://www.qiagen.com/us/resources/resource-detail?id=8fcb39a4-37f5-4ad2-8f41-68b0b8c3aaff&lang=en
Immunexpress (2022). SeptiCyte® RAPID – Clinical Performance Summary.
Summarises analytical and clinical validation data for SeptiCyte RAPID, an FDA-cleared host-response molecular assay for early sepsis diagnosis.
Available at: https://immunexpress.com/septicye-rapid/
Haute Autorité de Santé (HAS) (2024). Guide for Submitting Diagnostic Dossiers for LPPR Listing.
Defines the evidence, clinical benefit requirements, medico-economic criteria, and documentation necessary for coverage under the French LPPR reimbursement list.
Available at: https://www.has-sante.fr/upload/docs/application/pdf/2016-01/guide_fabricant_2016_01_11_cnedimts_vd.pdf
IQWiG (2023). General Methods – Version 7.2. Institute for Quality and Efficiency in Health Care (Cologne).
Germany’s official HTA methodology, covering evidence hierarchies, benefit assessment, diagnostics evaluation, patient-relevant endpoints and health-economic principles.
Available at: https://www.iqwig.de/en/about-us/methods/methods-paper/
NICE (2024). Health Technology Evaluation Manual. National Institute for Health and Care Excellence.
Sets out the methods for evaluating health technologies in England, including diagnostics, digital tools, biomarkers, and companion diagnostics.
Available at: https://www.nice.org.uk/what-nice-does/our-guidance/about-technology-appraisal-guidance/our-methods-and-processes-health-technology-evaluation-manual
European Medicines Agency (EMA) (2023). Scientific Opinion on Companion Diagnostics under Article 48(3) of IVDR.
Describes the EMA’s role in providing mandatory scientific opinions for CDx linked to centrally authorised medicinal products; outlines dossier expectations and review criteria.
Overview at: https://www.ema.europa.eu/en/human-regulatory/overview/companion-diagnostics
BIVDA (2024). The Value of IVDs in the UK Health System. British In Vitro Diagnostic Association.
Industry-level analysis of the economic, clinical, and operational value of IVDs to the NHS, with emphasis on early diagnosis, productivity, and improved patient outcomes.
Available at: https://www.bivda.org.uk/
McKinsey & Company (2024). Rethinking the In Vitro Diagnostic Testing Model in Europe.
Defines future trends in diagnostic innovation, decentralised testing, lab workflow modernisation, AI integration, consolidation, and new value-based reimbursement pressures.
Available at: https://www.mckinsey.com/
FAQ
1) What is “diagnostic repurposing” in IVD/CDx—and why does it matter for payers?
Answer: Repurposing reuses a validated assay/platform (e.g., NGS, qPCR, dPCR) for a new intended purpose or indication. It compresses development time, leverages existing analytical validity, and speeds regulatory and reimbursement (FDA 510(k)/PMA; IVDR CE; UKCA) when supported by bridging studies and real-world evidence (RWE) that shows incremental clinical utility and budget impact. NICE+3U.S. Food and Drug Administration+3EUR-Lex+3
2) FDA pathways for repurposed diagnostics: 510(k), De Novo or PMA—how do I choose?
Answer:
- 510(k): for substantial equivalence to a predicate (minor indication extensions/software updates).
- De Novo: no predicate, moderate risk (novel host-response/AI assays).
- PMA: Class III and most CDx tied to drug labels. Early Q-sub is advised to align datasets and IFU updates. U.S. Food and Drug Administration+1
3) What does IVDR Article 48 change for companion diagnostics (CDx)?
Answer: Under IVDR (EU 2017/746), every CDx gets a Notified Body review and a mandatory scientific opinion from EMA or the relevant NCA to ensure the diagnostic’s claim matches the medicinal product’s label; timelines and dossiers are defined, and changes in intended purpose trigger a new consultation. EUR-Lex+2European Medicines Agency (EMA)+2
4) What belongs in a Performance Evaluation Report (PER) when repurposing?
Answer: A PER integrates scientific validity, analytical performance (sensitivity, specificity, LoD, precision), and clinical performance (utility, outcomes). For repurposing, add bridging/orthogonal data for the new population/specimen, plus an updated intended purpose and risk management. EUR-Lex
5) How do I evidence incremental clinical utility for payers and HTA?
Answer: Show that the repurposed assay changes decisions and improves outcomes versus current practice: time-to-therapy, antibiotic-day reduction, ICU LOS, avoided adverse events, or survival/QALYs. Pair pragmatic RWE with modelled BIA/CCA/CUA. Map to NICE HTE, HAS/CNEDiMTS, and IQWiG/G-BA expectations. NICE+1
6) What is the NICE HealthTech Evaluation (HTE) route for repurposed IVDs?
Answer: HTE appraises non-drug tech (IVDs, AI), focusing on clinical effectiveness, cost impact and adoption feasibility. Supply RWE, cost-consequence and scenario analyses, and align with NHS priorities to enable funding levers (e.g., pilots/mandates). NICE+1
7) LPPR in France: what’s special for repurposed diagnostics?
Answer: Submit an LPPR dossier to HAS/CNEDiMTS (via SESAME) covering clinical value (SA/ASA) and, when required, economic evaluation; pricing is negotiated by CEPS. Repurposed claims need updated analytical/clinical evidence for the new indication and can leverage pre-submission meetings. Haute Autorité de Santé+3Haute Autorité de Santé+3Haute Autorité de Santé+3
8) What is RIHN 2.0 vs. standard LPPR for diagnostics in France?
Answer: RIHN is a conditional/temporary reimbursement route for innovative tests while collecting RWE, after which technologies move to standard LPPR with CEPS pricing. Use it to de-risk repurposed indications while generating post-market evidence. (The framework sits within HAS/CNAM toolset.) Haute Autorité de Santé
9) Germany’s NUB Antrag & ZE—how do they fund repurposed tests in hospitals?
Answer: NUB (by 31 Oct annually) enables temporary hospital funding for innovations; a positive Status 1 allows local price negotiations. A ZE (Zusatzentgelt) can standardise payments while awaiting DRG integration. Both benefit from clinical and economic data (e.g., ICU LOS savings). g-drg.de+2g-drg.de+2
10) US CPT/PLA and CMS LCD—what coding/coverage moves matter?
Answer: Apply for a PLA code (brand-specific) or ensure an appropriate CPT; secure LCDs with clinical-utility dossiers and RWE; successful regional LCDs may expand to NCD/private coverage. Keep labels/IFU and evidence fully consistent. CMS+3American Medical Association+3American Medical Association+3
11) What’s the role of EUDAMED for repurposing/renewals?
Answer: EUDAMED centralises UDI, certificates, vigilance and transparency across IVDR; any intended-purpose change and certificate updates must be reflected to maintain lifecycle traceability. Public Health+1
12) Can AI/ML diagnostic repurposing (e.g., radiology/pathology) use adaptive pathways?
Answer: Yes—regulators (MHRA/FDA/EMA) are piloting adaptive/abridged routes and sandboxes for AI/ML IVDs, with UK signalling reliance options and pragmatic IVD reforms. Maintain ML change control and performance monitoring. GOV.UK+1
13) How does the EU HTA Regulation (2021/2282) affect multi-country evidence?
Answer: It introduces Joint Clinical Assessment (JCA) and Joint Scientific Consultation, enabling consistent evidence for diagnostics across Member States and reducing duplicative assessments—vital for repurposed indications. EUR-Lex
14) Where can I source pan-EU RWE to support repurposing?
Answer: Use DARWIN EU (EMA’s federated network) and EHDEN (OHDSI/OMOP-based) to generate standardised, GDPR-compliant RWE that HTA bodies trust for lifecycle assessment. European Medicines Agency (EMA)+2ehden.eu+2
15) What’s the minimal bridging package to extend an assay to a new indication?
Answer: Analytical equivalence (or superiority) in the new matrix/population, clinical concordance vs reference/comparator, and a performance claim tied to outcomes (utility). Update PER, labelling/IFU, and risk file. EUR-Lex
16) How do I quantify value: ICER, BIA, and NMB for diagnostics?
Answer:
- ICER for CUA (cost/QALY).
- BIA for payer cash flow (ΔBudget = N×C deltas).
- NMB = (Effect×WTP) − Cost for decision simplicity. Pair with scenario and sensitivity analyses aligned to HTA manuals. NICE
17) What counts as clinical utility vs clinical performance in IVDR?
Answer: Clinical performance = ability to detect/measure the analyte (AUC, sensitivity). Clinical utility = impact on patient management/outcomes (e.g., time-to-therapy, avoided toxicity). Both are required to justify repurposing. EUR-Lex
18) Do LDTs still offer a route for repurposed assays in the US?
Answer: LDTs under CLIA remain possible but are moving toward harmonised FDA oversight; for market scale and payer coverage, many sponsors pursue FDA-cleared routes plus PLA/CPT coding. U.S. Food and
9) What is an Article 48 scientific opinion timeline and scope?
Answer: EMA/NCA reviews drug–diagnostic alignment (label/SmPC, utility, safety), while the Notified Body focuses on analytical/manufacturing. Timelines are bounded (IVDR guidance indicates structured clocks). European Medicines Agency (EMA)+1
20) How to tackle comparator selection when moving into a new care pathway?
Answer: Choose local standard-of-care comparators (culture vs PCR vs AI triage), justify via guidelines/claims utilisation, and pre-specify decision-impact endpoints and cost buckets relevant to the new setting.
21) Can one platform support multiple HTA submissions (UK/FR/DE/US)?
Answer: Yes—maintain a core evidence spine (PER, analytical dossier, pivotal/RWE) and tailor country annexes (NICE HTE focus on adoption; HAS SA/ASA; G-BA utility; CMS LCD clinical utility + coding). CMS+3NICE+3Haute Autorité de Santé+3
22) Does EUDAMED UDI help with post-market price reviews (e.g., CEPS)?
Answer: Indirectly—UDI/traceability underpins vigilance and utilisation transparency, which strengthens pricing negotiations tied to real-world performance and re-evaluation cycles. Public Health
23) How do UKCA timelines affect launch plans for repurposed IVDs?
Answer: Great Britain transitions to UKCA with reliance/abridged approvals under MHRA’s future framework. Northern Ireland continues IVDR under the Windsor Framework—plan dual routes and PMS. GOV.UK+1
24) What is a ZE (Zusatzentgelt), and when do I seek it?
Answer: A negotiated supplemental payment that standardises hospital reimbursement after successful NUB but before DRG inclusion—ideal once multi-centre utility is shown. g-drg.de
25) Can I expand a KRAS CDx from CRC to NSCLC under FDA and IVDR?
Answer: Yes—demonstrate analytical performance for G12C (or relevant variants), clinical utility with approved drugs (e.g., sotorasib/adagrasib), and update IFU/labels across FDA PMA supplement/510(k) or IVDR Article 48 pathways. U.S. Food and Drug Administration
26) What endpoints convince HTA for sepsis host-response repurposing?
Answer: Diagnostic AUC plus decision impact (earlier rule-in/out), antibiotic stewardship, ICU LOS, mortality/readmissions, and BIA reflecting savings in critical-care pathways.
27) How does JCA interplay with national pricing (CEPS, DRGs, ICSs)?
Answer: JCA harmonises clinical evidence; pricing/reimbursement (tariffs, budgets) remains national (CEPS/LPPR, DRGs/ZE, ICS/NHS tariffs). Provide one evidence core and multiple pricing annexes. EUR-Lex
28) When is a De Novo preferable to 510(k) for repurposed AI assays?
Answer: If the intended use creates a new product code or risk profile (no predicate), De Novo establishes a new classification for subsequent 510(k)s—speeding future indication add-ons. U.S. Food and Drug Administration
29) What does a CNEDiMTS SA/ASA grade influence in France?
Answer: SA confirms baseline benefit; ASA (I–V) sets added value and influences LPPR pricing via CEPS—so design studies to target a meaningful ASA. Haute Autorité de Santé
30) What documentation do NUB submissions require?
Answer: Innovation description, clinical evidence, economic rationale, expected patient volumes, and cost impacts; submit via InEK Datenportal and track request status. g-drg.de+1
31) How do I structure LCD evidence for repurposed assays?
Answer: Combine peer-reviewed data and real-world utility with test algorithm, intended use, target population, and coding; link to PLA/CPT descriptors and plan for post-coverage evidence. CMS+1
32) What are PER updates vs. PSUR for lifecycle HTA?
Answer: PER updates capture new validity/performance/utility; PSUR summarises safety/performance for Class C/D IVDs on a periodic cycle—both feed payer re-reviews (e.g., LPPR 5-year reassessments). EUR-Lex
33) Can multi-omics panels be expanded indication-by-indication?
Answer: Yes—use modular bioinformatics, indicate specific claim subsets, and staged bridging/validation; keep one wet-lab pipeline with software-based claim extensions (regulators accept with evidence). U.S. Food and Drug Administration
34) How should I present cost-consequences for diagnostics to NICE/HAS?
Answer: Tabulate resource deltas (tests, visits, admissions, ICU days), time-to-therapy, and downstream drug cost offsets; provide deterministic and probabilistic sensitivity analyses per manuals. NICE
35) What is EHDEN, and why do HTAs care?
Answer: EHDEN standardises EU health data (OMOP) across a federated network to produce transparent, reproducible RWE—supporting HTAs with scale and methodological consistency. ehden.eu+1
36) How do UKCA reliance and abridged approvals help?
Answer: MHRA plans to recognise trusted regulators (FDA, TGA, etc.) to abridge GB approvals, cutting time to market for repurposed IVDs while maintaining PMS vigilance. GOV.UK
37) What is a solid RWE plan for a repurposed test?
Answer: Prospective registry or pragmatic cohort across 3–5 centres; endpoints: decision impact, outcomes (LOS, readmission), and costs; link LIS/EHR to outcomes; pre-register analyses; share data for HTA. (DARWIN/EHDEN where feasible.) European Medicines Agency (EMA)+1
38) For a PLA application, what details must align with coverage?
Answer: Test name/descriptor, analytes/algorithm, specimen, intended use, and reporting must mirror your clinical-utility evidence and LCD asks. Cross-check AMA PLA descriptors and cycles. American Medical Association+1
39) What are common pitfalls that sink repurposing dossiers?
Answer: Misaligned intended use, weak comparator justification, insufficient bridging in the new matrix/population, and economics that ignore local tariffs/flows (EBM/OPS; LPPR/CEPS; ICS/NHS). Anchor every claim to guidance. EUR-Lex+1
40) Quick links: where do I find the official rules and databases?
Answer:
- FDA CDx hub & guidances; 510(k)/PMA. U.S. Food and Drug Administration+1
- IVDR (EU 2017/746) text & EUDAMED. EUR-Lex+1
- EMA Article 48 Q&A. European Medicines Agency (EMA)
- MHRA future regulations/roadmap. GOV.UK
- NICE HTE manual. NICE
- HAS/CNEDiMTS & LPPR submission. Haute Autorité de Santé+1
- InEK NUB/ZE portal: g-drg.de
- CMS MCD (LCD/NCD); AMA PLA. CMS+1
- EU HTA Regulation (2021/2282); DARWIN EU; EHDEN. EUR-Lex+2European Medicines Agency (EMA)+2