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General Laboratory Use software · professional review and signature required · EU data residency
Traceable genomic interpretation · AI-assisted

From the raw genome
to the signed report.

Traceable genomic interpretation that makes evidence — and uncertainty — visible.

One connected workflow for analysis, annotation, ACMG interpretation, pharmacogenomics and polygenic risk, preserving the evidence and the professional decision behind every reported finding.

prioritised_findings.reviewACMG · CPIC
BRCA2 c.5946delTPathogenic
MUTYH c.1187G>AVUS
TP53 c.215C>GBenign
CYP2D6 *2/*5 · CN=1IM
Evidence, uncertainty and unresolved regions presented for professional review and signature.
Designed for laboratory workflows
AI-assisted
ACMG/AMP · ClinGen SVI · CPIC/DPWG
Professional review
EU data residency
Reduce fragmented workflows.One chain from FASTQ to signed report.
Standardise interpretation.The same ACMG reasoning, recorded the same way, every case.
Make every limitation visible.Unresolved regions are declared, never omitted.
Sign with more confidence.Every finding traceable back to its evidence.
The problem we solve

An unresolved region should never look like a confirmed normal.

Conventional short-read workflows can struggle in highly homologous regions, structural events and areas with ambiguous coverage. When those limits are not made explicit, an unresolved region looks indistinguishable from a supported negative result.

Innovare surfaces coverage, mapping quality and unresolved evidence throughout the workflow, so a professional can tell a supported negative from a region that was never resolved.

Conventional output
BRCA1 c.68_69delreported
CYP2D6— absent from report
SMN1 exon 7— absent from report
A region absent from the report is indistinguishable from a negative result.
Innovare workflow
BRCA1 c.68_69delreported
CYP2D6resolved · *2/*5 CN=1
SMN1 exon 7flagged · not evaluable
What cannot be resolved is declared as not evaluable, not omitted.

Illustrative technical scenario.

Worked example · CYP2D6

What a silent false normal actually looks like

A pipeline that does not treat the CYP2D6 locus specifically does not return an error. It returns *1/*1 — a poor metaboliser reported as normal, with the same appearance of certainty as a real result.

22q13.2high-identity blocks shared with CYP2D7CYP2D8PCYP2D7CYP2D6A · Conventional germline pathsubstantial mapping ambiguityoutput: *1/*1 — false normalB · Specialised locus-specific analysiscoverage recoveredoutput: *2/*5 · CN=1 — structure resolvedread assignedMAPQ 0 — not usable for calling

CYP2D8P–CYP2D7–CYP2D6 locus at 22q13.2. Above, a conventional germline path: reads falling in the near-identical blocks shared with the CYP2D7 pseudogene have no unique destination, receive MAPQ 0 and carry no usable evidence. Below, the same material after a specialised locus-specific analysis. Schematic representation; metrics measured on our own samples. Full method in technical note NT-PGX-001.

Read the technical note

The workflow

One connected chain, from raw reads to signed report

STEP 01

Ingest

FASTQ, BAM, CRAM, VCF, gVCF — single or multiple runs

STEP 02

Align & call

Alignment and calling, with quality and coverage recorded per region

STEP 03

Annotate

Clinical databases and population frequencies

STEP 04

Interpret

ACMG engine, polygenic risk and CYP2D6 pharmacogenomics

STEP 05

Review & sign

Geneticist curation, read-level inspection, immutable signature

Capabilities

Depth where it matters

Every module is built to be inspected, not trusted blindly.

Signature module

CYP2D6 with structural resolution

A specialised locus-specific analysis for a locus that general-purpose pipelines routinely fail: null and reduced-function alleles, whole-gene deletion, duplication with copy number, and an explicit not-evaluable declaration when coverage is insufficient.

CPIC · DPWGCPIC · DPWG
Interpretation

ACMG classification engine

A Bayesian ACMG interpretation model aligned with ClinGen SVI recommendations, which records every criterion applied — and every one deliberately not applied — as an auditable ledger.

ClinGen SVIauditable ledger
Population

Ancestry-calibrated polygenic risk

Scores computed against reference panels, with explicit ancestry inference for Iberian and admixed Latino populations.

275+ traits
Visual review

Embedded read-level viewer

Inspect any variant against the aligned reads inside the portal, alongside an interactive workspace for filtering, shortlisting and exporting findings.

read-levelsee the workspace
Governance

Coverage decides what is reported

When effective coverage does not reach threshold, the gene is not reported. The rule is enforced consistently before reporting.

not evaluable ≠ normal
Reporting

Curation, signature & addendum

The geneticist edits the classification, records the criteria and signs. Signed content becomes immutable; later changes are issued as a traceable addendum.

immutable signature

Built on validated open bioinformatics standards, and aligned with ACMG/AMP, ClinGen SVI and CPIC/DPWG.

Analytical validation

Measured, and written up as dossiers

Every figure below comes from a self-contained study with a documented method, a defined acceptance criterion and a traceable dataset.

99.87%
Directional concordance
Pathogenic vs. benign direction against ≥3-star ClinVar reference labels, evaluated blind.
ClinVar reference study
94.8%
Precision in difficult regions
SNV and indel precision in challenging medically-relevant genes, HG002 against the GIAB CMRG benchmark.
DOSS-CLIN-CMRG-01
100%
Criterion agreement
Activation and strength of each ACMG criterion against ClinGen expert panels, across 2,314 criteria.
DOSS-CLIN-EREPO-01
90.3%
Final-class concordance
Same expert-panel study. Where classes differed, three quarters were the panel being more cautious (VUS).
DOSS-CLIN-EREPO-01

Directional concordance is computed only over variants where both the reference and the engine reached a conclusive call, and covers SNV and indels annotatable by the engine. These are analytical validation figures against reference truth sets and expert-panel classifications. Methodology, confusion matrices and discordance annexes are documented and available on request.

Capabilities in production

What the platform does today

Every capability listed here is in production and available for use.

SNV and indel germline calling
Available
ACMG classification enginewith auditable criteria ledger
Available
CYP2D6 with structural resolutiondiplotype, copy number, CPIC/DPWG
Available
Ancestry-calibrated polygenic riskexplicit ancestry inference
Available
Embedded read-level viewer
Available
Coverage gating & not-evaluable declarationper gene, before a report exists
Available
Curation, immutable signature & addendum
Available
Structured, versioned outputauditable record of evidence applied and not applied
Available

Declared use reflects intended purpose. Laboratories validate the software within their own quality system and remain responsible for the clinical interpretation and signature of every report.

Implementation

How a laboratory adopts it

The scientific differentiation matters only if it survives contact with a real laboratory.

Deployment

Cloud-hosted multi-tenant portal in EU regions. No local analysis infrastructure to provision.

Onboarding

Guided setup on your own cases, with your gene panels and report layout.

Validation support

Dossiers and reference-set results for your quality system. Your laboratory owns the validation.

Versioning & reanalysis

Every run records pipeline and knowledge-base versions, so a case can be reanalysed and compared.

Access & security

Named accounts, role-based access, tenant isolation and an immutable signature record per report.

Support

A named technical contact through onboarding and scientific support for interpretation questions.

Diagnostic services

Or send us the case, and we sign the report

A complete diagnostic service for clinics that want the result rather than the platform. Start from your own sequencing data or from a sample — the interpretation is ours, and it is signed.

Prevention

Preventive Exome

Genetic risk factors in a person with no symptoms, so prevention can be planned on evidence.

Diagnosis

Exome Focus & panels

Phenotype-driven analysis, or a curated panel when the differential is already narrow.

Family planning

Carrier screening

Individual or couple, with the combined reproductive risk and the residual risk made explicit.

Prescribing

Pharmacogenomics

CYP2D6 interpreted through a specialised locus-specific analysis, built for complex genomic regions.

See the full portfolio

Interpretation from your own sequencing data takes 7 working days; cases that start from a sample take longer. The clinical decision, consent and genetic counselling stay with the referring professional.

Declared purpose — General Laboratory Use (GLU)

Innovare is supplied as General Laboratory Use software. It is a genetic-interpretation support tool: it does not constitute a direct clinical diagnosis or a therapeutic recommendation, and it does not issue a clinical result autonomously. Results require professional review and signature before any clinical use.

The laboratory validates the software within its own quality management system and remains responsible for the interpretation, the report and the signature.

See it run on your data

Bring one representative case — ideally one where you suspect the answer was never actually computed. We will show you what the chain resolves, and what it declares as not evaluable.

app.innovaregenetics.com · for clinical & research laboratories