News Release
For immediate release
For further information please contact:
Ramanath Vairavan
Senior Vice President
760-477-2248 x 305
rvairavan@autogenomics.com
AutoGenomics Receives FDA Clearance for its INFINITI® CYP2C19 Assay
Vista, CA, October 26, 2010
AutoGenomics, a leader in providing automated, molecular testing solutions announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its INFINITI® CYP2C19 Assay. The test detects 3 genetic variants, *2, *3, *17, of the CYP450 2C19 gene and is to be used on the company’s automated molecular testing platform, the INFINITI® Analyzer.
"We are very excited to receive FDA clearance for our 2C19 test" said Fareed Kureshy,
President and CEO of AutoGenomics. "The necessity of this genetic test has been
implicated in literature now for several years. The FDA has now provided clinicians with
a tool in determining medical strategies for therapeutics that are metabolized by the
CYP 450 2C19 gene test specifically * 2, *3, *17. This is an important milestone in the
era of personalized medicine. Several of our customers are awaiting such clearance to
implement testing in their practice." He further said "we continue to expand our portfolio
of FDA cleared products". "The INFINITI® CYP 450 2C19 test is unique in evaluating
*17 which can help clinicians identify ultra metabolizers" said Robert Cole, MD., Chief
Medical Officer at AutoGenomics.
The INFINITI® System features a broad menu of 42 applications, with 5 FDA cleared
products and 16 CE marked products.
About AutoGenomics
AutoGenomics Inc., a privately held company based in Vista, CA, has developed the
first automated, microarray based multiplexing diagnostic platform 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.
www.autogenomics.com