By Ben Butkus
Orion Genomics said this week that it has non-exclusively licensed its MethylScreen technology to Qiagen for use in its EpiTect Methyl qPCR array kits for DNA methylation profiling and epigenetics studies.
Qiagen becomes the first company to license MethylScreen for research use, and the vote of confidence is expected to help familiarize researchers with the technology in advance of Orion developing its own DNA methylation-based diagnostic products, Orion President and CEO Nathan Lakey told PCR Insider.
From Qiagen's perspective, the deal allows it to add another tool to "one of the most comprehensive portfolios for epigenetics research" in the industry, Qiagen spokesperson Thomas Theuringer said.
Orion, based in St. Louis, has developed two technologies that enable both the discovery of methylation-based biomarkers and the development of corresponding assays. The first technology, MethylScope, uses microarrays or next-generation sequencing to build high-resolution, genome-wide methylation maps that enable the discovery of disease-related biomarkers.
The second technology, MethylScreen, uses methylation-sensing restriction enzymes and real-time PCR to quantitatively detect epigenetic biomarkers in samples, allowing "for more rigorous study of those biomarkers and development of corresponding assays," according to the company.
MethylScreen, when combined with Qiagen's DNA methylation qPCR assays and arrays, will allow customers to perform DNA methylation profiling of panels of 24 or 96 gene promoters simultaneously without prior bisulfite conversion.
"MethylScreen … is a way [to combine] restriction enzymes that are sensitive or dependent on DNA methylation with qPCR to study very precisely the density of methylation at a locus of interest," Lakey said. "In order to do that, though, one needs to optimize primer pairs that perform optimally on clinical samples at that locus. Qiagen has put quite a bit of effort into optimizing PCR assays for epigenetic loci that cover pathways. And [MethylScreen] combined with these optimized assays allows [Qiagen] to market pathway methylation kits."
Theuringer said that Qiagen's EpiTect product line includes products that cover all steps of epigenetics workflows from sample collection to result. For instance, the company offers EpiTect Plus Bisulfite and the EpiTect Whole Bisulfitome kits for bisulfite conversion.
On the analysis side it markets the EpiTect MSP kit for endpoint-based methylation-specific PCR; the EpiTect MethyLight PCR kit for probe-based real-time procedures; and selected pre-defined TaqMan-based assays using EpiTect MethyLight.
Meantime, Orion's MethylScreen technology is now being used in Qiagen's EpiTect Methyl qPCR Arrays. "Profiling of biological DNA samples with these arrays allows correlating CpG island methylation status with biological phenotypes or disease outcomes, and the results can provide insights into the molecular mechanisms and biological pathways critical for disease development," Theuringer said. He added that the "reliability and simplicity" of the combined offering make it an "ideal tool for semi-high-throughput DNA methylation profiling and biomarker development for various research fields like stem cell differentiation and development."
Orion noted that the licensing deal with Qiagen, its first in the research use field, validates its use in detecting methylation-based biomarkers in biological samples and should help establish MethylScreen as an epigenetics technology of choice among researchers.
More importantly, the more researchers use the technology in Qiagen's kits and publish data on its usefulness, the better for Orion's own diagnostic-development efforts with MethylScreen.
"The license to Qiagen will allow basic scientists to become familiar with MethylScreen, and to start publishing papers on their own biomarkers, and to really help the community become familiar with the kind of data that MethylScreen can generate," Lakey said.
"As the market starts to accept this assay as a leading way to evaluate DNA methylation, this will help speed up the market uptake of diagnostic tests that we would market in the future," he added.
More specifically, Orion is developing biomarkers in the area of breast, lung, ovarian, and bladder cancer. All of these potential diagnostic tests are in early clinical development and would leverage the MethylScreen technology, but Lakey did not disclose a development timeline.
The company also inked a collaboration and non-exclusive license agreement with Novartis in 2009 that gave the pharma giant access to MethylScope for mapping DNA methylation across the genome; and MethylScreen to detect specific methylation biomarkers and develop corresponding assays.
That partnership is progressing well and revolves generally around the area of personalized medicine in "multiple fields," Lakey said, though he declined to provide specific details due to a confidentiality agreement.
Orion also is developing a risk test for colon cancer, but it is not based on MethylScreen; rather, it is based on the epigenetic concept of loss of imprinting. And the company is working with the Malaysian Palm Oil Board to study the epigenetic makeup of oil palm in an effort to improve yields of this food crop and potentially important biofuel.
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