Clinoble Innovations builds clinical-grade screening platforms — from multi-cancer assays to portable diagnostics — designed to find disease years before symptoms do.
The deadliest diseases are the quietest — until you know how to listen.
Most conditions announce themselves years before symptoms — in circulating DNA, in retinal microvasculature, in biomarkers no one is watching. We build the instruments, assays and software that catch those signals at clinical grade, then put them where care actually happens.
One roof.
Six disciplines.
Screening products fail at the seams between disciplines. So we removed the seams.
Methylation, cfDNA and proteomic panels taken from bench to validated, deployable scale.
Custom imaging stacks — retinal, dermal, microfluidic — designed and built in-house.
Models trained on consented multi-site cohorts; validated like devices, not demos.
Working towards 510(k), De Novo and CE-MDR pathways — architecture and evidence planned around them from day one.
Multi-site studies run on our own telemetry — from first consent to database lock.
HIPAA-grade pipelines moving petabytes of signal without losing provenance.
Computational
preclinical sciences.
Two evidence services under one methodology: computational preclinical design, and EU MDR clinical evaluation. Both physician-led, both built to withstand review.
Evidence-weighted target assessment across Open Targets, DepMap, GTEx and GWAS resources, with tractability and safety liabilities surfaced before programme commitment.
Matching target biology to the appropriate knockout, knockin, conditional or humanised model — with documented rationale — before the model is commissioned.
Power calculation, randomisation and blinding schemes, endpoint selection, ARRIVE 2.0-compliant protocols and a full statistical analysis plan.
PRISMA 2020 systematic reviews and meta-analyses of disease-model and translational literature, delivered with reproducible search strategies and appraisal tables.
Biomarker strategy, PK/PD reasoning and allometric dose scaling to bridge animal findings toward first-in-human planning.
Nonclinical overviews and CTD Module 4 style summaries, structured for reviewer readability and traceable to source evidence.
EU MDR clinical evidence,
written to survive review.
Physician-authored clinical evidence: MEDDEV 2.7/1 Rev 4 and MDCG guidance (MDR) · Annex XIII performance evaluation (IVDR) — for SaMD, monitoring and Class I/IIa devices, and for IVDs.
Full CERs and CER updates authored to MEDDEV 2.7/1 Rev 4 structure, with defensible clinical benefit-risk determination and traceable evidence appraisal.
Structured responses to Notified Body clinical deficiencies — root cause, remediation and evidence, written to close the finding in one cycle rather than three.
Standalone SOTA sections built on documented, reproducible search strategies across PubMed, Embase and trial registries — the chapter reviewers challenge most.
Post-market clinical follow-up plans and evaluation reports, and Periodic Safety Update Reports aligned to the device's clinical evidence file.
Clinical, technical and biological equivalence assessment against MDCG 2020-5, with an honest gap register rather than an assertion of sameness.
Protocol-driven searches with PRISMA 2020 accounting, screening logs and appraisal tables — an audit trail a reviewer can reconstruct end to end.
Not shipped yet.
Already working.
Active internal programs — instrumentation, methodology and target discovery — ahead of the next product line.
Build what
finds it first.
Partnerships, licensing, clinical collaborations — or a role on the team. One inbox, read daily.
CLINOBLE
Clinical-grade screening platforms, built under one roof in Hyderabad, India.