By Ben Butkus
Qiagen and Epigenomics this week announced that they have entered into an option agreement that will enable Qiagen to develop and commercialize a colorectal cancer blood test based on Epigenomics' mSEPT9 biomarker and certain DNA methylation technologies.
With the agreement, Qiagen becomes the latest company to work with Epigenomics to craft a diagnostic based on mSEPT9. The assay interrogates cell-free methylated DNA of the SEPT9 gene in the blood, which Epigenomics and others have shown may indicate the presence of colorectal cancer.
Hopping on the Septin 9 bandwagon, Qiagen joins Epigenomics' commercial partner Abbott Molecular and licensees Quest Diagnostics, ARUP Laboratories, and Warnex Laboratories.
However, Qiagen is betting it can distinguish itself from the other players by developing a new front-end sample-preparation technology that will optimize an mSEPT9-based methylation test for use on Qiagen's newest molecular testing platform, QIAsymphony, Qiagen spokesperson Thomas Theuringer told PCR Insider this week.
"We are now in the process of developing that sample-prep technology," Theuringer said. "We are currently reviewing from an R&D perspective if it is manageable to develop this technology for the Epigenomics test and then integrate it to run on the QIAsymphony platform."
Qiagen did not disclose the nature of the sample-prep technology, saying in a statement that it would "meet the requirements for future broad implementation of methylation-based molecular diagnostics" such as the Septin9 colon cancer test. However, Theuringer provided some details on the nature of the problem Qiagen is trying to solve.
"We want to optimize the cancer test for QIAsymphony, making it more sensitive than currently available versions and thereby clinically more valuable," Theuringer said. "A more sensitive test allowing for an earlier detection of tumor cells improves a patient's chance for recovery significantly.
"In order to get better results and to find even [the] smallest numbers of tumor cells, you can either work on the assay part; or — and this is what we are going to work on now — you improve the sample-prep part by either trying to get more volume or by trying to get a better enrichment," he added.
Terms of the deal call for Qiagen to provide Epigenomics with an undisclosed up-front payment in exchange for an option to a worldwide non-exclusive license to the mSEPT9 biomarker and DNA-methylation technologies for the detection of colon cancer in blood.
Qiagen can exercise the option within the next two years, during which time Qiagen will develop and test its sample-prep technology and colon-cancer blood test on the QIAsymphony under an additional research license from Epigenomics.
Epigenomics will also support Qiagen in the R&D phase through know-how transfer and the collection of clinical specimens as required; and Qiagen will reimburse Epigenomics for this support.
Should Qiagen exercise its option, Epigenomics would receive an undisclosed additional license payment. Meantime, if Qiagen manages to commercialize an mSEPT9-based blood test, Epigenomics would be entitled to royalties on Qiagen's net sales and certain commercial milestones upon reaching specific revenue targets.
Qiagen's QIAsymphony instrument portfolio comprises the QIAsymphony SP for automated sample preparation and QIAsymphony AS for automated assay setup. When combined with the company's Rotor-Gene Q real-time PCR thermocycler, the entire outfit is called QIAsymphony RGQ.
The modular platform received a CE Mark in September and the company began selling it in the EU at that time. Qiagen anticipates launching the platform early this year in the US along with a development program involving more than 10 molecular assays.
The QIAsymphony platform competes with Abbott Molecular's m2000 fully automated clinical lab system, on which Epigenomics and Abbott have partnered to optimize an mSEPT9-based colorectal cancer blood test called Epi proColon.
Under that agreement, Abbott and Epigenomics market Epi proColon as IVD test kits in Europe and Asia/Pacific.
Epigenomics has also non-exclusively licensed its biomarker and associated methylation technologies to Quest Diagnostics, ARUP Laboratories, and Warnex Laboratories, all of which offer a laboratory-developed test based on the marker.
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