Horizon Diagnostics signed a partnership agreement with UK NEQAS to develop genetically defined reference standards for new lung cancer biomarkers. The reference materials will be used to minimize variability involved in FISH- and IHC-based diagnostic testing, which are used to guide prescription of targeted cancer therapies.
UK NEQAS ICC (the UK National External Quality Assessment Service) focuses on diagnostic proficiency assessment. Under the terms of the agreement, UK NEQAS ICC will receive an exclusive license to distribute reference standards related to certain lung cancer biomarkers in the U.K. and in Europe for the sole purpose of proficiency testing within its quality assessment program.
“Horizon’s application of its gene-editing technology in development of reference standards is ideally suited to diagnostics proficiency testing,” comments Keith Miller, director of UK NEQAS ICC. Paul Morrill, Ph.D., commercial director, Horizon Discovery, adds, “Newly discovered mutations are rapidly shaping how and when novel cancer therapies are prescribed, and quality assurance for diagnostics is a key factor in the prescription of these therapies. Through this partnership with UK NEQAS we look forward to seeing our genetically defined reference standards adopted in proficiency schemes and as batch controls, ultimately helping to improve the accuracy of diagnostic testing for patients.”
In September 2011 HorizonDx launched a suite of genetically defined fixed formalin, paraffin embedded cell line standards. These lines contain defined stoichiometric ratios of, among others, the seven variants of the Kras oncogene, for which testing is required to determine individual drug treatment regimens for colorectal cancer patients. The company says that it is the first company to provide reference standards containing defined allelic ratios.