Navigation Links
Everist Genomics Laboratory Receives Approval From U.S. Regulatory Authorities For High Complexity Clinical Testing
Date:3/7/2011

ANN ARBOR, Mich. March 7, 2011 /PRNewswire/ -- Everist Genomics announced today that it has received U.S. Clinical Laboratory Improvement Amendment (CLIA) certification required for the company to launch its OncoDefender-CRC assay, a prognostic test for assessing the risk of cancer recurrence for patients with early stage colorectal cancer.  Because OncoDefender-CRC is categorized by CLIA as a high complexity test, it is evaluated against the most stringent federally-mandated requirements, ensuring that the company's testing laboratory meets quality standards for accuracy, reliability and timeliness of patient results.

(Logo: http://photos.prnewswire.com/prnh/20110110/NY26865LOGO)

"Obtaining this regulatory certification represents a significant milestone in the company's commercial development path," said Prasad Sunkara, President and CEO of Everist Genomics. "Although Everist Genomics has always operated under rigorous scientific standards, it is encouraging to receive this type of regulatory validation from an independent authority. We expect that meeting the challenging certification guidelines enabling our clinical laboratory to perform high-complexity testing will give physicians and patients greater confidence when ordering the OncoDefender-CRC test."

OncoDefender-CRC, which measures the expression of colorectal cancer-specific genes, is the first and only molecular prognostic test capable of accurately predicting the risk of recurrence in patients previously treated with surgical resection of a Stage I/II colon cancer tumor or Stage I rectal cancer tumor. The company will officially launch the test later this month.

Everist Genomics released data from its external validation study of OncoDefender-CRC at the American Society of Clinical Oncology's 2011 Gastrointestinal Cancers Symposium in January. The study, which was conducted by Mayo Validation Support Services, indicated that the performance characteristics of the OncoDefender-CRC test are superior to other methods currently in use to predict recurrence.  Furthermore, studies demonstrate that high-risk OncoDefender-CRC results correlate with cohorts with higher risk of colorectal cancer recurrence within 3 years of surgery, while low-risk results correlate more closely with those patients without recurrence in 3 years.  

About OncoDefender™-CRC

OncoDefender-CRC colorectal cancer assay is a prognostic gene-based test used in stage I and II colon cancer and stage I rectal cancer patients that assesses the risk of recurrence of cancer following surgery. The test examines expression levels of a panel of genes extracted from formalin-fixed paraffin-embedded cancer tissue taken at the time of surgery, and uses a proprietary computer-generated decision rule to accurately and reliably identify patients who are at risk of recurrence.

About Everist Genomics

Everist Genomics is a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence and proprietary point-of-care equipment for the evaluation and management of cardiovascular disease. Using its patented Evolver™ technology platform, Everist Genomics is successfully developing and commercializing entirely new classes of patent-protected molecular biomarkers and sensor technologies which employ proprietary equipment, devices and software to help physicians make individualized treatment and drug prescribing decisions. The privately owned company was founded in 2002 and is located in Ann Arbor, Michigan. For more information, please visit www.everistgenomics.com


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

Related biology technology :

1. Everist Genomics Announces External Validation of OncoDefender™-CRC Test for Predicting Recurrence Risk for Stage I and II Colorectal Cancer Patients
2. Rosetta Genomics Announces Conference Call and Webcast of Second Quarter Financial Results
3. DOE JGI Director Eddy Rubin highlights the genomics of plant-based biofuels in the journal Nature
4. Rosetta Genomics Reports Second Quarter 2008 Financial Results
5. Rosetta Genomics and the National Institute of Health (NIH) to Identify Potential MicroRNA Drug Targets for HIV
6. eGenomics Awarded First U.S. Patent Covering Rapid DNA Sequencing Technology Platform to Control Hospital-Acquired Infections
7. Transgenomic Announces Partnership With Key Genomics for Ovarian Cancer Assay to Guide Therapeutic Options
8. U.S. Genomics Inc. Receives $4.5 Million Investment from BD
9. Helix BioPharma to Present L-DOS47 Research Findings at the National Research Council of Canadas Eighth Annual General Meeting of the Genomics and Health Initiative in Saskatoon, Canada
10. TIBCO Spotfire and INTEGROMICS Announce Genomics Data Analysis Solution to Radically Speed Drug Research and Development
11. LI-COR Biosciences Offers $1.75 Million in Matching Funds for Undergraduate Genomics Education
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/15/2017)... ... August 15, 2017 , ... Kenall, a ... downlights designed to stay tightly sealed and perform efficiently for years. The downlights ... location listings just aren't enough, such as: hospitals; behavioral health facilities; cleanrooms; containment ...
(Date:8/15/2017)... ... 2017 , ... JULABO USA introduces its new website ... it easy to navigate through the site whether you’re in the office, in ... educational industry content and visit the company’s social media accounts, all on one ...
(Date:8/14/2017)... York, NY (PRWEB) , ... August 14, 2017 , ... ... in Clinical Trials event, which will take place on September 6, 2017 at ... Daniel Karlin, MD , Head of Experimental Medicine, Informatics, and Regulatory Strategy, Pfizer Innovative ...
(Date:8/11/2017)... , ... August 11, 2017 , ... Algenist continues to ... formulation unlocking collagen like never before. , Collagen is the key structural element ... market with Liquid Collagen™, which include: , First to ...
Breaking Biology Technology:
(Date:4/13/2017)... , April 13, 2017 According to a new ... Authentication, Identity Analytics, Identity Administration, and Authorization), Service, Authentication Type, Deployment Mode, ... IAM Market is expected to grow from USD 14.30 Billion in 2017 ... (CAGR) of 17.3%. ... MarketsandMarkets Logo ...
(Date:4/11/2017)... MELBOURNE, Florida , April 11, 2017 ... "Company"), a security technology company, announces the appointment of independent ... John Bendheim to its Board of Directors, furthering the ... ... behalf of NXT-ID, we look forward to their guidance and ...
(Date:4/5/2017)... 4, 2017 KEY FINDINGS The ... at a CAGR of 25.76% during the forecast period ... primary factor for the growth of the stem cell ... MARKET INSIGHTS The global stem cell market ... and geography. The stem cell market of the product ...
Breaking Biology News(10 mins):