Lab21 Announces Exciting Companion Diagnostic Partnership

Lab21 Limited, has entered into an agreement with one of the world’s leading pharmaceutical companies (as yet unnamed) to develop, manufacture and distribute a new companion diagnostic assay. The assay will detect specific mutations in colorectal cancer samples, to enable selection of patients for the partner company’s therapeutic monoclonal antibody.

Under the agreement 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. In addition, the Company will provide specific sample analysis service from its accredited laboratory in Cambridge, UK on behalf of the partner.

Graham Mullis, CEO of Lab21, commented: “We are pleased to enter into a new companion diagnostic assay partnership with a major pharma company to develop and co-brand this assay. 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 better support the stratified patient requirements of their drug.”

Berwyn Clarke, CSO of Lab21, 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. Lab21 is intent on providing efficient development of cost-effective, market-leading biomarker products to its pharmaceutical partners using its extensive experience in both nucleic-acid and protein-based diagnostics. 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 SPARQTM PCR Technology and will be co-branded with the partner. 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 is expected to be the first of a pipe-line of new companion diagnostic assays.