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:10/11/2017)... ... October 11, 2017 , ... ComplianceOnline’s Medical Device Summit ... 7th and 8th June 2018 in San Francisco, CA. The Summit brings together current ... several distinguished CEOs, board directors and government officials from around the world to address ...
(Date:10/11/2017)... ... October 11, 2017 , ... A ... pregnancy rates in frozen and fresh in vitro fertilization (IVF) transfer ... age to IVF success. , After comparing the results from the fresh and ...
(Date:10/10/2017)... ... October 10, 2017 , ... Dr. Bob Harman, founder and CEO ... Diego Rotary Club. The event entitled “Stem Cells and Their Regenerative ... attendees. Dr. Harman, DVM, MPVM was joined by two human doctors: Peter B. ...
(Date:10/9/2017)... , Oct. 9, 2017  BioTech Holdings ... mechanism by which its ProCell stem cell therapy ... limb ischemia.  The Company, demonstrated that treatment with ... of limbs saved as compared to standard bone ... molecule HGF resulted in reduction of therapeutic effect.  ...
Breaking Biology Technology:
(Date:4/11/2017)... N.Y. , April 11, 2017 ... fingerprints, but researchers at the New York University ... College of Engineering have found that partial similarities ... security systems used in mobile phones and other ... thought. The vulnerability lies in the ...
(Date:4/5/2017)... , April 4, 2017 KEY FINDINGS ... anticipated to expand at a CAGR of 25.76% during ... diseases is the primary factor for the growth of ... report: https://www.reportbuyer.com/product/4807905/ MARKET INSIGHTS The global ... product, technology, application, and geography. The stem cell market ...
(Date:3/30/2017)... -- Trends, opportunities and forecast in this market to ... AFIS, iris recognition, facial recognition, hand geometry, vein recognition, ... industry (government and law enforcement, commercial and retail, health ... and by region ( North America , ... , and the Rest of the World) ...
Breaking Biology News(10 mins):