Lhasa Limited is pleased to announce the release of Kaptis 3.1, offering enhanced guided decision support for carcinogenicity assessment. This update reflects the continued commitment by Lhasa to support transparent, structured and scientifically defensible decision-making in an area where complex data and evolving regulatory expectations can create uncertainty.
As the UK and international regulatory landscape continues to accelerate the replacement of animal testing with scientifically robust alternative approaches, the role of New Approach Methodologies (NAMs), including in silico tools, is becoming increasingly critical. In response to the UK strategy for replacing animals in science, Lhasa brought together experts from across industry, academia and the non-profit sector to develop a collaborative, industry-led framework for translating this ambition into practice. As this work and wider international efforts support the development, validation and uptake of alternative methods, confidence in how evidence is generated, integrated and justified will be essential for regulatory acceptance.
Supporting clarity in complex carcinogenicity decisions
Assessing carcinogenic potential involves interpreting diverse streams of evidence, identifying key gaps and determining whether further studies are necessary. Without clear guidance, this process can be time-consuming and open to differing interpretations, particularly when multiple scientific disciplines and stakeholders are involved.
Kaptis 3.1 has been developed to help address this challenge by introducing a structured, question-based approach that guides users through the key considerations of a robust carcinogenicity assessment. The aim is to help toxicologists and regulatory scientists across pharmaceutical sectors and beyond focus their resources where they will make the greatest impact, reducing ambiguity and strengthening the justification behind their decisions.
Bringing structure and transparency to the assessment process
The new guided decision support provides:
- A clear, stepwise route through the assessment
Guiding users through required data, key scientific considerations, and next steps in the evaluation process. - Improved visibility of evidence gaps
Highlighting where additional studies, assays or justification may strengthen the assessment. - Confidence scoring with transparent rationale
Each conclusion is supported by a confidence level and explanation, improving traceability and scientific justification.
Together, these enhancements help ensure that the reasoning behind an assessment is clear, consistent and easier to communicate to internal and external stakeholders.
Supporting regulatory alignment and NAMs adoption
While applicable broadly across carcinogenicity assessment, these improvements support alignment with internationally recognised weight-of-evidence principles, including those described in ICH S1B(R1). By strengthening the clarity and traceability of scientific reasoning, Kaptis 3.1 helps organisations engage more effectively in regulatory dialogue and supports the broader uptake of NAM-based approaches in safety assessment.
Enhanced knowledge and workflow experience
Kaptis 3.1 also includes an expanded scientific knowledge base, including updates to carcinogenicity adverse outcome pathway (AOP) networks and increased coverage of immunomodulation-relevant biology. A new dedicated review panel brings together key evidence and actions in a single view, improving workflow efficiency and decision transparency.
Enabling confident, human-relevant safety decisions
By improving clarity, consistency and traceability in decision-making, Kaptis 3.1 enables users to:
- Build stronger, more transparent scientific rationales
- Focus effort on the most meaningful scientific questions
- Reduce time to decision in development workflows
- Improve shared understanding across teams and with regulators
This release reinforces the commitment by Lhasa to providing trusted, scientifically robust tools that support confident, human-relevant safety decisions while contributing to the reduction and eventual replacement of animal testing.
For more information about how Kaptis can support confident carcinogenicity assessment or to explore the guided decision functionality, please get in touch with the Lhasa team.