Frequently asked questions

Classifying actionability according to AMP/ASCO/CAP means sorting each detected variant into tiers of clinical relevance following the joint framework of the Association for Molecular Pathology, the American Society of Clinical Oncology and the College of American Pathologists. That framework distinguishes variants of strong clinical significance, potential clinical significance, uncertain significance and benign or likely benign variants, drawing on evidence levels that range from regulatory approval and guidelines to preclinical studies or isolated case reports. The classification does not indicate which treatment to give: it indicates how much evidence supports an alteration being clinically relevant in a specific tumour context.

TMB (tumour mutational burden) is a measure of the number of somatic mutations per megabase of the tumour genome, and MSI (microsatellite instability) reflects a defect in DNA mismatch repair mechanisms. Both are biomarkers assessed independently of point variants and are considered in clinical guidelines when evaluating certain therapeutic strategies, particularly immunotherapy. Their interpretation depends on the panel used, the calculation method and the tumour type, so they should be read alongside the laboratory report rather than as an isolated value.

OncoCore processes single nucleotide variants, insertions and deletions, copy number variations (amplifications and losses), gene fusions and rearrangements, and aggregate signatures or biomarkers such as TMB and MSI. Fusions receive specific treatment because their clinical relevance depends on the genes involved, the breakpoint and whether the reading frame preserves the functional domain. When the laboratory report does not provide the detail needed to characterise a fusion, the system makes that explicit rather than assuming it.

The system cross-references the drugs under consideration and the patient's concomitant medication against structured information from summaries of product characteristics and regulatory sources, assessing mechanisms such as CYP3A4 inhibition or induction and other relevant metabolic pathways, and flagging drugs associated with QT interval prolongation. The result is a documented warning with its corresponding source, not a substitution recommendation or a dosing schedule. The final assessment, including any need for electrocardiographic monitoring or therapeutic adjustment, rests with the clinical team and the hospital pharmacy service.

When relevant clinical information is missing, the system states so explicitly and describes how that absence conditions the interpretation, instead of filling the gap with an assumption. Variables such as performance status (ECOG), previous lines of therapy, central nervous system involvement, comorbidities or concomitant medication change how the same molecular alteration should be read. This explicit handling of uncertainty is a design principle: we prefer an output that flags its limits to one that appears complete without being so.

Yes. Every statement in the report is linked to the source that supports it: clinical guideline, publication with its PMID, trial registry entry, summary of product characteristics or regulatory database, together with the version used. The aim is that a professional can verify the reasoning without leaving the document and disagree with it on solid grounds. A clinical system whose conclusions cannot be audited is not usable in a tumor board.

No. OncoCore organises and documents information for clinical discussion; the treatment decision always belongs to the care team and the tumor board. The system does not automatically prioritise one drug over another as an indication, nor does it replace assessment of the patient's individual context. Its role is to reduce the work of gathering and verifying information, leaving clinical judgement where it belongs.

The current development scope focuses on non-small cell lung cancer (NSCLC), a domain with a particularly extensive molecular and therapeutic landscape. Working on one tumour type first allows the necessary depth to be reached before widening coverage. Extension to other tumour subtypes is part of the roadmap, without publicly committed dates.

A clinical service can collaborate by taking part in an evaluation of OncoCore in a real setting, using already-resolved cases or a framework that does not interfere with the care decision. The usual process starts with an introductory video call, continues with joint definition of scope and of the formal framework, proceeds with the evaluation supported by the Sphera team and ends with a shared analysis of conclusions. The way to get in touch is the form on the contact page.

The clinical service contributes judgement, cases and real operational context, and gains early access to the tool, direct influence over its design and documentation of the work carried out. Sphera contributes the development, the support and the adaptation of the system to the service's protocols. The working framework is formalised in writing, respects the centre's procedures and the GDPR, and does not interfere with care decisions.

Pricing is defined according to the scope of deployment: number of users and services involved, hosting model, degree of integration with hospital systems and level of adaptation required. During the current clinical evaluation phase, conditions are agreed specifically with each collaborating centre. We do not publish fixed rates because they would not reflect implementation scenarios that differ so widely.

It depends on the agreed scope and on the centre's requirements, particularly regarding security, hosting and integration with existing systems. A limited evaluation can be set up with very little infrastructure, whereas a structured integration with hospital systems requires the involvement of the information systems department and its own timelines. We prefer to define a realistic schedule case by case rather than announce generic timeframes.