Omica Diagnostics
Identify biomarker-eligible patients directly from routine pathology.
Omica deploys AI screening across partner pathology networks in Latin America, flagging suspected biomarker-positive cases for reflex confirmatory testing and clinical trial referral.
Program workflow
From routine biopsy to confirmed patient without interrupting clinical workflow.
Screening occurs prospectively on existing specimen volume. Reflex testing prioritizes candidate cases without requiring blanket molecular testing across every patient.
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01
Routine H&E in PRISMA
Participating laboratories scan and review cases within PRISMA as part of standard clinical practice.
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AI pre-screening
Validated predictive models analyze routine H&E slides upon scanning, identifying cases with high probability of biomarker expression.
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Confirmatory testing
Flagged specimens reflex immediately to validated IHC or molecular testing across the network. AI enriches the cohort; standard assays establish diagnosis.
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Clinical referral
Patients with confirmed biomarker status are routed to participating trial sites or precision therapy programs with full pathology documentation.
Biomarkers
Scalable screening for routine targets and rare emerging indications.
For rare biomarkers, reflexing every patient to molecular assays is cost-prohibitive. AI pre-screening on routine H&E concentrates candidate volume to make targeted trials feasible.
- HER2Breast, gastric
- HER2-lowBreast
- Molecular subtypeBreast
- MSI / dMMRColorectal, endometrial
- Claudin 18.2Gastric
- Custom targetAssay calibration
Established biomarkers
Routinely indicated biomarkers where testing access or turnaround is constrained. Pre-screening prioritizes confirmatory workflows to expedite clinical decision-making.
Emerging-therapy biomarkers
Low-prevalence biomarkers where broad molecular screening is economically impractical. Pre-screening evaluates high-volume routine pathology to surface candidate cases for confirmatory sequencing.
Program models
Trial enrollment, companion diagnostics, and retrospective prevalence.
Programs are configured around your target biomarker, inclusion criteria, and regulatory milestones.
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01
Trial enrollment
Prospective AI screening across regional pathology networks. Confirmed patients are referred to investigational sites prior to initiation of non-targeted therapy.
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Companion diagnostics
Multi-center clinical validation studies supported by centralized tissue access, digital slide archives, and comprehensive regulatory documentation.
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Prevalence and validation
Retrospective validation across digitized, annotated historical cohorts to characterize target prevalence and assay performance prior to prospective screening.
Program monitoring
Real-time visibility across participating screening sites.
Monitor active screening metrics across participating sites in real time: total slides evaluated, AI flags generated, confirmatory assay status, and completed patient referrals.
| Site | Status | Screened | Flagged | Confirmed | Progress |
|---|---|---|---|---|---|
| Site 01 | Active | 412 | 63 | 24 | |
| Site 02 | Active | 298 | 41 | 17 | |
| Site 03 | Active | 276 | 44 | 16 | |
| Site 04 | Active | 184 | 27 | 10 | |
| Site 05 | Activating | 70 | 11 | 4 |
An example program. Sites, counts, and cases are illustrative, not real data.
Centralized operations
A single centralized network agreement across participating institutions.
- Sites
- Contract and onboard clinical sites under a unified master service agreement rather than negotiating individual hospital contracts.
- Regulatory
- Programs operate under our centralized regulatory framework, with coordinated institutional ethics committee reviews and complete documentation.
- Screening
- Automated ingestion and model execution within PRISMA as routine slides are digitized at source laboratories.
- Confirmation
- Centralized reflex testing including immunohistochemistry, targeted NGS panels, whole-exome sequencing, and RNA-seq.
- Tissue
- Deep multimodal characterization of FFPE blocks, frozen tissue, and tissue microarrays through the Omica Cancer Atlas.
- Delivery
- Streamlined referral packages, population prevalence reports, annotated multimodal validation cohorts, and regulatory submission dossiers.
Clinical footprint
Screening powered by active clinical pathology networks.
Network sites utilize PRISMA for daily diagnostic operations. Clinical programs leverage this operational footprint to evaluate routine specimens from day one, with consented cases integrated into the Omica Cancer Atlas.
Operations
Frequently asked questions
Does the AI make the diagnosis?
No. The AI performs pre-screening and cohort enrichment. Every flagged specimen reflexes to validated IHC or molecular confirmatory assays and undergoes pathologist review prior to patient referral.
Which biomarkers can a program target?
Both established targets with testing bottlenecks (such as HER2 and HER2-low) and novel biomarkers tied to investigational therapies. Predictive algorithms are calibrated and validated for your specific assay criteria before screening begins.
Can we deploy our own proprietary algorithm or assay?
Yes. We can deploy sponsor-provided models across network slide streams, validate algorithms retrospectively on historical cohorts, or integrate designated central laboratory assays for confirmation.
How are identified patients referred to investigational sites?
Confirmed patients are referred through their attending oncologists to participating clinical trial centers, accompanied by standardized pathology reports and assay documentation. Referral workflows are established with local principal investigators during program initiation.
What is the timeline to initiate a prospective program?
Retrospective validation studies on digitized archives can initiate immediately. Prospective screening begins upon completion of central ethics approvals, site onboarding, and algorithm verification, typically within 6 to 10 weeks.
What regulatory support do you provide?
Programs operate under our established regulatory framework. Omica coordinates institutional ethics committee submissions across participating sites and prepares analytical validation dossiers suitable for regulatory submissions.
What deliverables are provided upon program completion?
Deliverables include verified patient referrals, comprehensive population prevalence analyses, curated multimodal validation datasets, and complete audit-ready regulatory documentation.
How are programs structured and priced?
Programs are structured on a milestone or per-specimen basis depending on biomarker prevalence, participating site count, screening volume, and confirmatory testing requirements. Contact our clinical partnerships team to define project specifications.