EntroGen has a new BRAF test that detects, beside the V600E mutation, also the V600K and the V600D, which are important mutations found in melanoma. 

The test kit contains 64 reactions and it can be run on all real-time PCR instruments capable of detecting FAM and VIC fluorescent probes.

More information about the new EntroGen BRAF test can be found here.

At the JIB Congress in Paris, 8^th – 10^th November 2011, BÜHLMANN presents the MDx products of EntroGen and AutoGenomics as well as new developments of its own unique products. Read more about BÜHLMANN Innovations and News and visit us at our stand Curie D93.

The INFINITI^® CYP2C19 test detects three genetic variants, *2, *3, and *17 of the CYP450 2C19 gene.

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

The AutoGenomics Applications List and Applications Overview List for the INFINITI® product line are now available. You can download them on our webpage.

more