An alliance between Lab21 in Cambridge UK and one of the world’s leading pharmaceutical companies has been formed to create new cancer diagnostic technology.The aim is to develop a companion assay to detect specific mutations in colorectal cancer samples to select patients for the pharma partner’s therapeutic monoclonal antibody.
It is understood that this is the first example of a pharmaceutical company co-branding a companion diagnostic.
Lab21 expects to launch the product during the current year under the OnconosticaTM brand name and it is expected to be the first of a pipeline of new companion diagnostic assays.
Financial details of the agreement were not disclosed.
Lab21 is a global specialist in personalised medicine and clinical diagnostics. It will use its molecular diagnostic development resource and proprietary SPARQ™ PCR technology together with its expertise in the oncology diagnostic market to develop, manufacture and distribute the assay.
The company will also provide specific sample analysis service from its accredited laboratory in Cambridge on behalf of the partner.
CEO Graham Mullis said: “Lab21 has significant experience in molecular diagnostics in the oncology setting and the combination of this with our proven assay development capability, regulatory and manufacturing knowhow has been recognised by a major pharma in order to better support the stratified patient requirements of their drug.”
CSO Berwyn Clarke added: “As global regulatory authorities drive the requirement for linked companion diagnostic assays for licenced drugs this necessitates very close co-operation between pharmaceutical and diagnostic businesses.
“The outcome of this partnership will be a new assay which matches the best quality currently on the market, combined with more user-friendly performance and greater cost-effectiveness.”
The assay will be based on Lab21’s recently acquired and proprietary SPARQTM PCR Technology and will be co-branded with the partner.