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OncoMethylome Sciences, Merck, Aureon Laboratories, MD Anderson Cancer Center, Xceed Molecular, Moffitt Cancer Center, Gentag, MacroArray Technologies, Case Western Reserve University, Translational Genomics Research Institute, Affymetrix, Laboratory Corp

OncoMethylome to Provide Methylation Testing Services for Merck Study
OncoMethylome Sciences said this week that it will provide MGMT gene promoter methylation testing services for Merck KGaA’s clinical trial program for cilengitide, a drug being developed for glioblastoma multiforme treatment.
As part of the agreement, Germany’s Merck also gained a worldwide, non-exclusive license to use the results from the methylation assay for optimizing cilengitide treatment.
Liege, Belgium-based OncoMethylome said that its MGMT assay is based on studies that showed methylation of the MGMT gene promoter may help to identify brain tumors that are more likely to respond to standard chemotherapeutic agents.

MD Anderson Inks Two Deals to Advance Personalized Lung Cancer Treatments
Aureon Laboratories will work with MD Anderson Cancer Center to search for biomarkers associated with non-small cell lung cancer patients, the Yonkers, NY-based company said this week.
Under the collaboration, Aureon will work with MD Anderson associate professor of pathology Ignacio Wistuba to quantitate and evaluate biomarkers that may be linked to disease progression and the probability of survival. The project will use Aureon’s systems pathology platform, which uses morphometric imaging on formalin-fixed, paraffin-embedded tissue specimens, to study tissue from around 350 NSCLC patients.
The company said its system allows it to quantitate and integrate histological attributes and multiplexed protein biomarkers on a cell-by-cell basis. Aureon also said it has developed a multivariate algorithm that can integrate histological, molecular, and clinical features in order to identify phenotypes associated with the course of a disease.
This approach “allows a better understanding of the biological context in terms of assessing therapeutic response,” Aureon President and CEO Vijay Aggarwal said in a statement.
Aggarwal also said that the company’s system has shown utility in stratifying NSCLC patients who are treated with Iressa, a common drug treatment for the disease.
In a separate announcement, Rosetta Genomics said last week that it will collaborate with researchers at the MD Anderson Cancer Center and the Kleberg Center for Molecular Markers to develop a microRNA-based test to predict risk of disease recurrence in lung cancer patients who have undergone curative resection.
The partners said patients with high risk of recurrence may benefit from adjuvant therapy after surgical resection, but low-risk patients may be exposed to unnecessary toxicities.
They hope to develop a test that will enable physicians to distinguish between patients with high risk and low risk of recurrence, which would help them optimize treatment regimens.
“By leveraging microRNAs’ unique sensitivity as biomarkers, we have an opportunity to develop a novel test that will assist clinicians and patients to better manage this type of cancer,” Ignacio Wistuba, associate professor in the department of pathology at MD Anderson Cancer, said in a statement.
The Kleberg Center for Molecular Markers is part of MD Anderson.

Xceed Molecular Licenses Moffitt Gene Signature for Colon Cancer Dx Research
Xceed Molecular has licensed the rights to use a gene signature for colon cancer from the Moffitt Cancer Center, the company said this week.
The Wellesley, Mass.-based firm has purchased the worldwide, exclusive rights to use the gene signature to develop a molecular test that can predict patient prognosis for the disease, which Xceed said is diagnosed in over 100,000 Americans each year. Xceed will work with Tampa, Fla.-based Moffitt researchers to complete clinical development and validation of the signature, which uses biopsy tissues from colonoscopy to predict the chances of return of the disease.
The collaborators hope to develop a list of genes that Xceed will include in its TipChip colon cancer microarray device that runs on the company’s Ziplex System. Xceed said that it will run the first samples in its Expression Services Lab in Toronto to optimize the performance of the signature on the Ziplex System. The company also will provide Moffitt with a Ziplex for additional validation studies.
“We have high hopes that the gene signature that we are developing may be useful in helping physicians to make critical treatment decisions, but the great challenge in this field has been turning promising biomarkers into routine diagnostic tools,” Tim Yeatman, a Moffitt researcher who helped develop the colon cancer gene signature, said in a statement.

Gentag, MacroArray to Collaborate on Wireless Prostate Cancer Assay
Privately held firms Gentag and MacroArray Technologies said this week that they will collaborate on developing a wireless immunoassay for prostate cancer.
The new test would combine Gentag’s cell-phone sensor technology with MacroArray’s proteomics discovery technology to create a disposable, wireless diagnostic test.
Gentag said the test would work similarly to currently available pregnancy strip tests, with men placing a urine sample on a test strip that incorporates an imbedded wireless tag. Antibodies on the strip would react with the sample and resulting data would be sent to an attending physician.
The firms plan to develop additional diagnostic tests based on their combined technologies, but the prostate cancer test is first in the pipeline.

Case Western, TGen to Use Affy Arrays in Diabetes Study
Case Western Reserve University and the Translational Genomics Research Institute will use Affymetrix’s Human SNP Array 6.0 to study genetic pathways associated with a certain complication of diabetes, Affy said this week.
The two institutions will use Affy’s arrays to focus on finding genetic links to diabetic nephropathy using data from a study by the National Institute of Diabetes and Digestive and Kidney Diseases.
The Family Investigation of Nephropathy and Diabetes (FIND) Consortium research program stretched over five years and involved 11 different recruitment centers and 10,000 subjects. The FIND Consortium has identified several genetic variants linked to nephropathy in African-Americans, European-Americans, Mexican-Americans, and American Indians.
The researchers involved in this end of the project hope to use the information to develop therapies to prevent or control nephropathy, and to identify people at risk for progressive renal disease.
"Diabetes continues to mystify researchers because both genetic and environmental factors appear to play significant roles in the manifestation of the disease,” Affymetrix President Kevin King said in a statement.
Financial terms of the agreement were not released.

LabCorp Inks Companion Dx Pact with Vanda
Laboratory Corporation of America said last week that it will develop and distribute a series of diagnostic tests that will be companions for a schizophrenia drug made by Vanda Pharmaceuticals.
The tests will be based on a series of genetic markers Vanda discovered while developing an antipsychotic drug that is now undergoing review by the US Food and Drug Administration.
Under the agreement, LabCorp will be Vanda’s exclusive commercialization partner for companion tests for the drug iloperidone, which the company plans to market under the name Fanapta.
Financial terms of the agreement were not released.

Siemens Healthcare Establishes MDx Research Facility in Germany
Siemens Healthcare last week said that it has established a new research lab focused on molecular diagnostics in Cologne, Germany.
The medical imaging and diagnostics giant said that the initial focus of the research labs will be on breast cancer diagnostics. It said that it would employ biochips in developing the tests, but did not say whether the chips were developed internally or are based on another company’s technology.
Siemens noted that it currently has 40 employees in Cologne developing molecular diagnostic tests for cancer.
“Viewed from the perspective of Siemens, a medicine that is more strongly based on molecular medical and knowledge-based techniques will be able to make important long-term contributions toward improving the quality and increasing the efficiency of healthcare,” Donal Quinn, CEO of the Diagnostics Division of Siemens Healthcare, said in a statement.

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