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Quest Licenses Septin 9 Marker from Epigenomics


Epigenomics has licensed to Quest Diagnostics its DNA-methylation biomarker Septin 9, which the company will use to develop a homebrew colorectal cancer diagnostic.

Quest is the first commercial laboratory in the US to obtain a non-exclusive license to the Septin 9 biomarker from Epigenomics to manufacture a laboratory-developed colo-rectal cancer test. Epi-genomics granted Quest exclusivity for an undisclosed period for being a "first-mover" in the US, in exchange for upfront and milestone payments, as well as royalties on sales of the test.

Epigenomics' deal with Quest comes five months after Epigenomics licensed the marker to Abbott, which will use it to develop a Septin 9-based in vitro diagnostic kit. However, this kit will take some time to come to market, since it will require regulatory approval from the US Food and Drug Administration and CE mark in Europe. Abbott will likely launch the test kit in Europe in 2009 and in the US in 2010.

Quest plans to develop the Septin 9 DNA methylation test, which could be available in the US as early as this year, as a supplement to conventional methods of colorectal cancer screening, including colonoscopy and fecal occult blood tests.

Currently, many patients refuse to undergo colonoscopy sbecause of its cost or its invasiveness. Since the diagnostic test will be blood-based, it has the potential to improve compliance — "the major problem with current screening," an Epigenomics spokesperson says. If the disease is detected early, patients have a 90 percent chance of surviving for at least five years.

In clinical trials, Epigenomics has demonstrated that methylated DNA of the Septin 9 gene in blood plasma can help gauge the presence of asymptomatic, early-stage colorectal cancer. By encoding a protein involved in cell division, Septin 9 is thought to play a role in oncogenesis.

— Turna Ray

PGx & Molecular Dx Notes

Pharmaceutical services company Althea Technologies spun out its molecular diagnostics and biomarker business to an independent company called Althea Diagnostics. Althea is developing a test for differential diagnosis of pediatric solid tumors and other biomarker sets for cancer management.

Gen-Probe has filed for clearance with the US Food and Drug Administration for additional use of the Procleix Ultrio assay to screen for hepatitis B virus in donated blood. Approval would let Gen-Probe administer its assay on its semi-automated platform and on its fully automated, high-throughput TIGRIS system.

Warnex Medical Laboratories has a nonexclusive license from Xenomics to use acute myeloid leukemia marker in a diagnostic test. 


A chain of spas will offer a 27-gene test kit from Sciona to help customers structure their diet and nutrition programs. 

Funded grants


Novel Diagnostic Sequencing System for HIV Resistance Testing
Grantee: Jerzy Olejnik, Intelligent Bio-Systems
Began: June 15, 2007; Ends: May 31, 2009
The National Institute of Allergy and Infectious Diseases gave this award to Olejnik to develop an inexpensive, highly sensitive genotyping system that would check for HIV-1 resistance among patients undergoing anti-retroviral drug therapy. The tool will be based on Intelligent Bio's massively parallel sequencing platform. 

Considerations of Covariates in Biomarker Studies
Grantee: Margaret Pepe, Fred Hutchinson Cancer Research Center
Began: Aug. 1, 2007; Ends: May 31, 2011
Pepe will use the award to study how covariates have an impact on biomarker evaluations and to develop techniques to include them in data analysis procedures. The goal is to emerge with a better understanding of how covariates can be used to improve the predictive quality of biomarkers.

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