Volume of genomic data
Broad NGS panels return dozens of variants, fusions and biomarkers, most without therapeutic implications. Separating signal from noise requires repetitive curation work in every case.
Flagship product
Sphera OncoCore: clinical and molecular decision support for tumor boards
Sphera OncoCore is a comprehensive clinical and molecular decision support application designed for precision oncology. It processes next-generation sequencing (NGS) panel results, cross-references them against up-to-date clinical knowledge bases and produces a structured, auditable report linked to its sources, designed to fit into the tumor board workflow.
What problem does OncoCore solve?
OncoCore addresses the mismatch between the volume of information that now accompanies an oncology case and the time a tumor board actually has to assess it. Every session requires reviewing lengthy sequencing reports, checking which findings are actionable under current guidelines and verifying whether the candidate drug is viable in that particular patient — all in minutes, case by case.
Continuously updated guidelines
NCCN and ESMO recommendations and actionability classifications change frequently. Keeping that reference current while sustaining clinical activity is difficult.
Scattered pharmacological criteria
The viability of a targeted therapy depends on product characteristics, reimbursement conditions, interactions and toxicities held in different sources and different formats.
Tight timelines
The board must reach a recommendation within the session itself. When preparation eats up the time, less room is left for the clinical discussion, which is where the value lies.
How does OncoCore translate genomic findings into clinical decisions?
OncoCore turns the sequencing report into an ordered list of findings with their clinical significance and evidence level made explicit. To do so it normalises the nomenclature of each alteration, places it in its biological context and cross-references it against clinical knowledge bases before classifying its actionability.
NGS panel processing
The system interprets single nucleotide variants, insertions and deletions, copy number variations and structural rearrangements, including complex fusions whose notation varies between laboratories. Normalisation is the step that allows the same finding to be recognised consistently, whatever format it arrives in.
TMB and MSI biomarkers
Tumour mutational burden (TMB) and microsatellite instability (MSI) are assessed as biomarkers in their own right, not as just another variant, because they guide different decisions from those driven by a specific target alteration. When the report does not provide them, the system states so rather than inferring them.
Cross-referencing knowledge bases
Every relevant finding is checked against clinical knowledge bases and the NCCN and ESMO reference frameworks, collecting the publications, trials and recommendations that support its interpretation.
AMP/ASCO/CAP actionability classification
OncoCore applies the joint AMP, ASCO and CAP framework, which sorts somatic variants into four tiers according to the strength of the evidence supporting their clinical significance. The tier always accompanies the finding, so the board knows how much weight each option carries before discussing it.
- Tier I
- Biomarkers of established clinical significance: professional guidelines and well-conducted clinical trials support their use to guide treatment in that tumour type.
- Tier II
- Clinical significance supported by less mature studies, expert consensus or evidence derived from a different tumour type.
- Tier III
- Potential clinical significance: the variant opens the door to a clinical trial or to a therapeutic hypothesis that requires assessment.
- Tier IV
- Preclinical or purely functional evidence, with no established therapeutic implication.
How does OncoCore verify drug safety?
OncoCore checks every targeted option against official summaries of product characteristics and regulatory sources before presenting it, so the molecular and pharmacological assessments reach the board together. An actionable finding is only useful if the corresponding drug can actually be given to that patient.
Official pharmacological sources
The system integrates information from CIMA, EMA and FDA summaries of product characteristics, and consults BIFIMED for reimbursement conditions. Every data point keeps its provenance, so the board can see which document a contraindication or an authorised indication comes from.
Anticipated interactions
When assessing an option, OncoCore automatically anticipates foreseeable drug-drug interactions, with specific attention to CYP3A metabolic pathways and to the risk of QT interval prolongation when drugs with that profile are combined.
Toxicity and contraindications
The report includes the expected toxicity profile and the documented contraindications of each candidate therapy, so relevant warnings appear in the same place where the option is discussed rather than in a later review.
What does the system do when clinical data is missing?
It declares it. Before suggesting a course of action, OncoCore identifies the clinical variables that determine a drug's suitability and are absent from the information received, and presents them to the board as points to confirm. Uncertainty is managed explicitly instead of being resolved with assumptions.
This behaviour avoids the costliest error in a decision support system: presenting an apparently complete recommendation that in fact rests on a data point nobody has checked. By exposing the gap, the system keeps responsibility for the assessment where it belongs and steers the conversation towards what is missing.
Examples of variables the system asks to confirm
Performance status (ECOG)
Conditions the expected tolerance to certain therapies and their indication.
Central nervous system involvement
Determines whether drugs with documented intracranial penetration should be prioritised.
Previous lines of therapy
Define which line the patient is in and which options remain available.
Comorbidities and concomitant medication
Needed to assess interactions and contraindications accurately.
Can the system's reasoning be audited?
Yes, in full. Every statement in the report is linked to its original source — publications identified by their PMID, registered clinical trials, professional guidelines and summaries of product characteristics — so the board can walk through the molecular reasoning step by step: from the variant detected to the recommendation derived from it, through every intermediate piece of evidence.
In a clinical setting traceability is not an optional feature but a condition of use. A professional taking responsibility for a treatment decision needs to be able to check what it rests on: an output that cannot be verified cannot be assessed, cannot be debated in session and cannot be defended in a later review. That is why OncoCore is designed without black boxes and documents the full path, including the points where evidence is weak or contradictory.
How does it adapt to each hospital's information systems?
Through a modular, scalable architecture and, above all, because we develop the system ourselves. We do not resell a closed solution: we can adjust the interface, the input and output formats and the integration logic to the protocols, workflows and information systems of each service.
Independent modules
Molecular interpretation, pharmacological checks and report generation are separate pieces, so a centre can adopt the scope it needs.
Tailored output formats
The report adapts to the document the board already uses, so it fits into the session without forcing a change of workflow.
Integration with the centre's systems
With the IT department we define the exchange route with the HIS or the electronic health record viewer, in line with the hospital's security requirements.
What place does OncoCore hold in the clinical decision?
That of a support tool: OncoCore does not replace clinical judgement, nor does it aim to. Its role is to structure the available biological and pharmacological knowledge quickly, in an ordered and unbiased way, so the board can devote its time to clinical discussion and to patient care.
The treatment decision remains a clinical act that integrates the patient's context, history and preferences. What the system contributes is that the discussion begins with complete, verifiable and already organised information on the table.
Workflow
A case travels through OncoCore in five steps, from the sequencing report input to the traceable document that reaches the board session.
- 1
NGS report and clinical data input
The system receives the sequencing report and the clinical data available for the case.
- 2
Molecular interpretation and actionability
It normalises variants, fusions and biomarkers and classifies their actionability according to AMP/ASCO/CAP.
- 3
Pharmacological and safety checks
Each targeted option is checked against product characteristics, interactions, toxicities and contraindications.
- 4
Detection of missing variables
It sets out the clinical data the board must confirm before validating the suitability of a drug.
- 5
Traceable report for the board
It generates a structured document in which every statement links back to its original source.
Current development status
OncoCore is under active development. The knowledge base is consolidated for non-small cell lung cancer (NSCLC), which is the system's current clinical scope, and the roadmap foresees progressively extending coverage to other tumour subtypes, prioritising those where molecular interpretation weighs most heavily on the board's decision.
At this stage the system is intended for research and clinical evaluation, not for routine care. We are looking for oncology services, molecular pathology units and hospital pharmacy teams interested in evaluating it with real cases and helping define its output criteria and its integration into the board session.
Frequently asked questions about OncoCore
In summary
- Sphera OncoCore is a clinical decision support system (CDSS) for precision oncology, developed by Sphera Innovation.
- It processes next-generation sequencing (NGS) reports, including gene fusions, tumour mutational burden (TMB) and microsatellite instability (MSI).
- It classifies the actionability of each alteration according to the AMP/ASCO/CAP framework and takes the NCCN and ESMO guidelines as reference.
- It verifies drug safety against summaries of product characteristics from CIMA (AEMPS), EMA and FDA, and against BIFIMED: interactions, risk of QT interval prolongation, toxicities and contraindications.
- Its current clinical scope is non-small cell lung cancer (NSCLC) and it is under active development, intended for research and clinical evaluation: it does not replace professional clinical judgement.
Request a demonstration with a practical case
We prepare a session around an NSCLC case to show the full path: from the incoming NGS report to the traceable report the board receives.
Sphera OncoCore is a platform under development, intended for research and clinical evaluation purposes. It does not hold CE marking as a medical device and is not intended for use as a diagnostic or prescribing tool. Every clinical decision remains the responsibility of the treating healthcare professional.