ARTICLE | Company News
Loxo and Roche's Ventana Medical Systems Inc. unit partnered to develop and commercialize a pan-neurotrophic tyrosine kinase (TRK) immunohistochemistry (IHC) companion diagnostic to identify solid tumor patients suitable for treatment with Loxo's larotrectinib.
Roche, which will use its OptiView DAB detection technology, is responsible for developing the companion diagnostic test in the U.S., "major" countries in the EU and others that recognize CE mark approval. The partners expect to first globally commercialize an analytical assay, then submit a PMA to the FDA for a Class III assay...