Lab21, a healthcare diagnostics company, has reached agreement with Innogenetics to create a powerful IP portfolio relating to hepatitis C virus (HCV) drug resistance.
The Lab21 IP has recently been granted in Europe and Australia and covers the analysis of sequence variation within the viral serine protease NS3, while the Innogenetics IP covers the viral polymerase protein NS5B - a major target in current pharmaceutical drug development.
Collectively, the two sets of IP will cover analysis of sequence variation across these two major antiviral targets for all six major genotypes of HCV.
The combination of the two sets of IP is intended to allow Lab21 or other diagnostic partners to develop commercial assays for the rapid identification of genotypic variations associated with HCV drug resistance, which is expected to be an emerging problem in clinical practice as new small-molecule therapies are launched.
Graham Mullis, chief executive officer of Lab21, said: 'Using the precedent of HIV antiviral drug resistance as a predictor of the growing HCV drug-resistance market means there will be a clear requirement from both a regulatory and a clinical perspective to be able to identify the emergence of such resistance.
'As new HCV therapies, focused on the NS3 and NS5B genes, are launched over the next five years, the issue of genotyping patients to identify specific drug resistance profiling will be a major requirement to successfully treat patients.
'This IP area is an example of the investment that Lab21 is making in developing its own proprietary diagnostic testing,' he added.
The IP covers any nucleic-acid-based technology that requires amplification of the target genes and will include existing analytical platforms such as direct sequence analysis, line-probe hybridisation, real-time PCR and SNP analysis.
The IP has already been developed into working laboratory assays capable of rapidly analysing sequence variation across the entire NS3 and NS5 protein.
Currently, the partnership is undertaking a strategic assessment to decide how best to commercialise and maximise the market opportunity.
Dr Berwyn Clarke, chief scientific development officer, said: 'We believe that the IP around the NS3 and NS5B genes will be central to the development of commercial assays to monitor the emergence of specific drug-resistance patterns in the clinic.
'Target customers for assays based on this IP will include pharmaceutical companies developing HCV therapeutics, commercial diagnostic manufacturers, routine pathology laboratories and clinical research organisations running HCV clinical trials,' he added.
