Navigation Links
AutoGenomics Receives FDA Clearance for its INFINITI® CYP2C19 Assay
Date:10/26/2010

VISTA, Calif., Oct. 26 /PRNewswire/ -- 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


'/>"/>
SOURCE AutoGenomics
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. AutoGenomics Invited to Present at Thomas Weisel Partners 2009 Healthcare Conference
2. AutoGenomics New RVP Assay Addresses Current Challenge to Detect Flu A - Swine H1N1
3. AutoGenomics Invited to Present at the 2009 JPMorgan Healthcare Conference
4. Silence Therapeutics Receives Comprehensive Protection for RNAi Structural Modification Technology in Single European Patent
5. UCLA engineering receives $6M to construct new state-of-the-art building
6. Sangart, Inc. Receives $1.1 Million Grant Award from the United States Department of Defense for Further Development of MP4 Molecule in Trauma
7. EarlySenses EverOn(R) Central Display Station (CDS) Receives FDA Clearance
8. Maven Biotechnologies Receives $1.96 Million From the National Institutes of Health (NIH) to Develop Their LFIRE™ Label-Free Detection Technology for Proteomics
9. Collagen Matrix, Inc. Receives FDA 510(k) Clearance for New Collagen Dental Membrane Based on Porcine Collagen Platform Technology
10. Xiaoguang Meng receives honorary master of engineering from Stevens
11. AMT Receives Orphan Drug Designation From the U.S. Food and Drug Administration Duchenne Muscular Dystrophy Gene Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... ... April 27, 2016 , ... The Pittcon Organizing Committee ... Chuck has been a volunteer member of Committee since 1987. Since then, he ... of directors and treasurer and was chairman for both the program and exposition committees. ...
(Date:4/27/2016)... , ... April 27, 2016 , ... ... Jon Clark has joined the company as an Expert Consultant. Mr. Clark ... industry collaborations and managing the development of small molecule monographs based on analytical ...
(Date:4/27/2016)... PARIS , April 27, 2016 ... system disorders, today announces the appointment of Catherine Moukheibir as ... succeed MedDay,s previous Chairman, Jean Jacques Garaud , who ... The change is effective immediately. Catherine started her ... Boston and London .  She ...
(Date:4/26/2016)... ... April 26, 2016 , ... Heidelberg Instruments, a leader ... innovation for its Volume Pattern Generator (VPG) line of lithography systems. The breakthrough ... as well as a solution for mid volume direct write lithography applications. ...
Breaking Biology Technology:
(Date:4/28/2016)... GOTHENBURG, Sweden , April 28, 2016 ... 1,491.2 M (139.9), up 966% compared with the first quarter of ... Operating profit totaled SEK 589.1 M (loss: 18.8) and the operating ... SEK 7.12 (loss: 0.32) Cash flow from operations was ... , The 2016 revenue guidance is unchanged, SEK 7,000-8,500 M. ...
(Date:4/19/2016)... 2016 The new GEZE SecuLogic ... web-based "all-in-one" system solution for all door components. It ... the door interface with integration authorization management system, and ... The minimal dimensions of the access control and the ... installations offer considerable freedom of design with regard to ...
(Date:4/14/2016)... , April 14, 2016 ... and Malware Detection, today announced the appointment of ... the new role. Goldwerger,s leadership appointment comes ... the heels of the deployment of its platform at ... behavioral biometric technology, which discerns unique cognitive and physiological ...
Breaking Biology News(10 mins):