Lab21 to develop cancer diagnostic assay with leading pharma company
Onconostica product to be launched later this year
Lab21, a UK-based specialist in personalised medicine and clinical diagnostics, has agreed an alliance with a leading pharmaceutical manufacturer to develop a new cancer diagnostic assay.
The aim is to develop a companion assay to detect specific mutations in colorectal cancer samples to select patients for the partner’s therapeutic monoclonal antibody.
Lab21 expects to launch the product during the current year under the Onconostica brand name. It is expected to be the first of a pipeline of companion diagnostic assays.
Financial details of the agreement were not disclosed.
Lab21 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, UK on behalf of the partner.
Lab21’s chief executive 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 know-how has been recognised by a major pharma in order to support better the stratified patient requirements of their drug.’
Berwyn Clarke, chief scientific officer, added: ‘As global regulatory authorities drive the requirement for linked companion diagnostic assays for licensed drugs this necessitates very close co-operation between pharmaceutical and diagnostic businesses.
‘The outcome of this new partnership will be a new assay which matches the best quality that is 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 SPARQ PCR Technology and will be co-branded with the partner.