Companion Diagnostics

We develop and commercialize companion diagnostics, under design control and in accordance with 21 CFR part 820 and ISO 13485, that aid in the selection of patients for novel therapies.

Central Pathology Review

Our expert pathologists aid partners in determining optimal candidates for inclusion in clinical trials and monitor drug responses.

Novel Assay Development

We develop novel assays, across a range of different assay types, that are designed to address emerging or customized needs.

Regulatory Submission

Our team has extensive experience in guiding devices through the submission process and interfacing with global regulatory bodies and requirements.

Commercial Testing

Embedded within a national reference laboratory, we commercialize and scale testing for clinical use.

Support for Rare Diseases and Underserved Populations

Our unique connection to an academic reference laboratory with deep subspecialty expertise enables us to support novel therapeutics for rare diseases and medically underserved patients.