Our industry-leading portfolio of on-market IVD assays features the greatest number of companion diagnostics for targeted and immunotherapies, covering multiple indications. We also offer an impressive menu of 75+ clinical trial ready assays supported in our CAP/CLIA lab, which includes many important emerging biomarkers as well as multiplex panels.
Along with the development of promising new cancer medicines that target treatment of mismatch repair (MMR) deficient solid tumors has come significant scientific and clinical interest in MMR proteins as predictive biomarkers. An immunohistochemistry (IHC) predictive assay would potentially pave the way for treatment decisions to be made based on detection of deficiency for MMR proteins (MLH1, MSH2, MSH6 or PMS2) across many types of solid tumors. These proteins are currently used clinically to help differentiate between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer.
Assays customized to pharma’s needs
Robust prototype assay (RPA)
Allows biomarker hypothesis testing during early phase clinical studies with no immediate CDx development need. Offers flexibility for use in further research.
Formulation locked assay (FLA)
For biomarker hypothesis testing during early phase clinical studies with intent of transitioning to a CDx. Hybrid approach establishes assay feasibility and minimizes risk .