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.

Why clinical development starts here

A biomarker that only works in the lab where it was discovered is not a trial assay yet. Nucleai closes that gap: the same validated algorithm, the same quality system, deployed through the infrastructure your sites already run on, scoring every patient the same way for as long as the trial lasts, and ready to carry forward if a companion diagnostic is the next step.