May 14, 2007 - AutoGenomics Inc., a leader in developing automated molecular testing solutions, announced today that it has obtained clearance from the FDA to market its INFINITI Analyzer as stand alone instrumentation for multiplexed assays. In February, this year, the company reported that it had obtained clearance for its INFINITI System Assay for Factor II & Factor V as an in vitro diagnostic device that consisted of reagents and instrumentation.
"Molecular testing is becoming an integral part of the clinical laboratory. This clearance validates the integrity of our automated multiplexing platform to provide the desired quality, reliability and robustness to customers and enable them to develop and use multiplexed applications on the INFINITI Platform" said Fareed Kureshy, President and CEO of AutoGenomics.
AutoGenomics has already submitted another 510(k) application to the FDA for its INFINITI 2C9 / VKORC1 Multiplexed Assay to assess Warfarin sensitivity and has plans to file for FDA clearance for additional applications in its expanding test menu in pharmacogenetics, genetic disorders, infectious diseases and cancer diagnostics.
For more information visit www.autogenomics.com