The same algorithm that found
the biomarker is the one that runs in the trial.
Nucleai Select takes a validated spatial biomarker, discovered through Nucleai Insight or defined by the sponsor, and builds it into a deployable, validated scoring algorithm under design control. It runs inside the trial workflow your sites already use, and the same offering carries a trial assay into a companion diagnostic pathway if one is required.
NUCLEAI SELECT · CLINICAL TRIAL ASSAY
Clinical Trial Assay (CTA): which patients go into this trial, and how do we score consistently across every site?
A tissue biomarker that reads consistently in the research lab can read differently once it moves across twenty sites and many pathologists. Enrollment and on-study scoring decisions depend on a result that has to be the same regardless of who is reading the slide and where, and for the full length of the trial.
Nucleai Select starts with a biomarker in hand. We build the validated biomarker into a scoring algorithm and deploy it into the trial workflow through an IVD partner's platform or a central laboratory. Following exploratory work with Nucleai Insight, the underlying biomarker can move into the trial with reduced bridging efforts for technology transfer, revalidation, or restart with a new partner. We run development under design control, producing the documentation a future submission will need as the work happens.
Best fit for: Clinical development teams bringing a validated biomarker into a live trial.
From slide to consistent patient selection
Case Study: CTA Develop and Deploy
For a top 10 biopharma sponsor, IHC co-expression algorithms were developed and validated under design controls against pathologist scoring at >85% agreement for clinical cutoffs. The locked models were integrated into a CLIA lab digital pathology workflow and used to assist pathologist scoring in a prospective deployment of clinical trial assays (CTA). This resulted in 10 validated algorithms released for use 10 indications.
Case Study: Throughput at Scale
In a multi-site harmonization study, more than 2,000 paired slides were scored to a consistent standard in four weeks. This represents the throughput and cross-site consistency a live trial assay has to sustain for as long as the study runs.
From trial assay to companion diagnostic (illustrative)
NUCLEAI SELECT · COMPANION DIAGNOSTICS
When a companion diagnostic is required, the algorithm doesn't start over
Where a trial assay succeeds and a drug moves toward approval, a companion diagnostic may be required to bring the same biomarker to market alongside it. Nucleai Select is built to carry a trial assay through that regulated pathway with minimal bridging efforts. Nucleai’s algorithm, operating under its quality management system, will support the IVD manufacturer leading the regulatory submission.
Certified to Quality & IT Standards
Nucleai's products are designed, developed and deployed utilizing risk-based implementation of our ISO 13485 compliant quality management system as well as our ISO/IEC 27001 compliant information security management system.
