AccuGenomics develops standardized molecular testing kits that support the personalized medicine market. On March 17, 2015, the company was awarded a United States patent 8,981,068, which has critical claims for their standardized molecular testing platform. “We are very excited about the issuance of this patent”, says Tom Morrison, Chief Science Officer of AccuGenomics. “The patent’s broad claims cover the fundamental use of competitive template mixtures to control for the process variation that negatively impacts current quantitative molecular testing. The more complex molecular tests are housed in centralized laboratories in an attempt to use industrialized processes to control for testing variation. AccuGenomics AccuKit platform decentralizes standardized molecular testing by providing the critical controls in every test reaction. AccuKits allow hospitals to take back financial and regulatory control of these outsourced complex molecular tests.
AccuGenomics plans to seek FDA registration of their first AccuKit for monitoring BCR-ABL treatment in 2016. Despite efforts to standardize BCR-ABL testing through use of reference samples to calibrate laboratory testing process, their remains significant interlaboratory differences in measurement and sensitivity. The BCR-ABL AccuKit provides the necessary quality controls to ensure that every measurement achieves the required sensitivity and linear response independent of clinician, laboratory and time. Patent 8,981,068 claims protect the core quality control technology of the AccuKit platform.