AutoGenomics receives 510 (K) clearance for INFINITI™ Assay for Factor II & Factor V Leiden
Carlsbad, CA. February 12, 2007 - AutoGenomics Inc., a leader in developing automated molecular testing solutions, announced today that it has obtained 510(k) clearance from the FDA for the INFINITI™ System Assay for Factor II & Factor V Leiden as an in vitro diagnostic device that consists of reagents and instrumentation (INFINITI™ Analyzer). The automated system includes hybridization matrices (BioFilmChip™ microarray), PCR primers, thermal cycler, an imager (confocal microscope) with software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI™ System Assay for Factor II & Factor V Leiden is a qualitative assay indicated for use as an aid in the diagnosis of patients with suspected Thrombophilia.
“We are very pleased that the FDA has given clearance to our automated microarray system” said Fareed Kureshy, President and CEO of AutoGenomics. “This clearance establishes AutoGenomics as the leader in automation for multiplexed DNA testing using microarrays enabling clinical laboratories to significantly enhance workflow efficiency”.
AutoGenomics has already submitted another 510(k) application to the FDA for its INFINITI™ System Assay for 2C9 / VKORC1 and is considering additional applications for its expanding test menu in pharmacogenetics, infectious disease and cancer diagnostics.
AutoGenomics Inc., a privately held company based in Carlsbad, CA, has developed one of the first microarray based multiplexing diagnostic platforms that can be used to assess disease signatures with novel genomic and proteomic markers in the area of genetic disorders, infectious disease, cancer and pharmacogenetics. With the discovery of genes and their link to various disease states the platform has the versatility to revolutionize the way patients are diagnosed, monitored and managed leading to the era of personalized medicine. For more information, please visit www.autogenomics.com
For further information please contact:
Senior Vice President Sales & Marketing, AutoGenomics
760-804-7378 x 305