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Matrix-Bio Options Metabolite Biomarker Technology from Purdue University to Evaluate Opportunities for New Cancer Diagnostic Tests

Matrix-Bio Inc., a diagnostics company that uses metabolite profiling to detect cancer and other diseases, has signed an exclusive agreement with the Purdue Research Foundation optioning metabolite biomarker technology and eight patent applications to evaluate the commercial potential of cancer diagnostics tests based on the technologies.

The optioned technologies include metabolite biomarkers for detecting esophageal, liver, pancreatic and colon cancer; for identifying liver cancer in patients with hepatitis C; and for predicting preoperative chemotherapy effectiveness for breast cancer treatment. Matrix-Bio’s agreement is for one year with an option to extend the agreement. No other terms of the agreement were released.

The new agreement builds on the existing master license agreement between Matrix-Bio and Purdue Research Foundation for breast cancer biomarkers and metabolite profiling technology developed by Dan Raftery, Matrix-Bio chief scientific officer and founder, while he was a member of the Purdue University research faculty. Raftery is now director of the Northwest Metabolomics Research Center at the University of Washington in Seattle, and is also a member of the Fred Hutchinson Cancer Research Center in Seattle, one of the world’s leading cancer research centers.

Matrix-Bio CEO Eric Beier said the agreement will enable the company to significantly expand its pipeline of cancer detection and monitoring tests, further advancing the company’s leadership in metabolomics-based cancer diagnostic technologies.

“Metabolite profiling is an emerging field of diagnostics that looks at the changes in small molecule biomarkers in cells. Patterns of these metabolite biomarkers in the blood are altered when cancer is present,” Beier said. “Dr. Raftery’s technology identifies metabolic changes with very high sensitivity and specificity, and can detect various cancers in early, more treatable stages more accurately than currently available tests. Studies have also demonstrated that metabolite profiling can assist in monitoring cancer treatment.”

The announcement comes on the heels of an exclusive global licensing and marketing agreement for metabolomic biomarkers Matrix-Bio signed with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services. Under the agreement, Quest Diagnostics has the rights to use the Matrix-Bio biomarkers for the future, potential development of a clinical lab-developed test to aid in the detection of breast cancer recurrence. Quest Diagnostics also has the option to pursue an appropriate regulatory pathway for an in vitro diagnostic version of the test. Additional terms were not disclosed.

Source: Business Wire

Luminex Corporation and EMD Millipore Extend Their Global Supply and Distribution Agreement

Luminex Corporation (NASDAQ: LMNX) recently announced it has extended their global supply and distribution agreement with EMD Millipore—the Life Science division of Merck KGaA, Darmstadt, Germany. This long-term agreement strengthens the partnership and facilitates development of life science and protein assays by EMD Millipore for Luminex’s flexible platform.

OGT Marks World Lupus Day with Announcement of Novel Biomarker Panel

Oxford Gene Technology (OGT), provider of innovative genetics research and biomarker solutions to advance molecular medicine, has today announced the development of a novel autoantibody biomarker panel for improved diagnosis of systemic lupus erythematosus (SLE).

The panel has been developed in partnership with King’s College London, utilising OGT’s proprietary protein array platform technology. The platform detects autoantibodies, a class of proteins that have been shown to precede clinical symptoms of SLE by several years. It also accurately distinguishes between SLE and ‘confounding diseases’ such as rheumatoid arthritis (RA).

The biomarker panel, which was originally identified using a North American sample cohort, has been rigorously validated in two independent sample cohorts comprising over 450 European, Afro-Caribbean, and confounding disease samples. The panel maintains a high sensitivity and specificity across all cohorts studied.

SLE affects at least five million people worldwide, over 90% of whom are women. The figure may be higher as SLE is notoriously challenging to diagnose with widely variable symptoms which are inconsistent in patients. Current diagnosis is usually performed by comparing a patient’s symptoms against 11 pre-set criteria established by the American College of Rheumatology. If the patient presents any four of the symptoms simultaneously or serially on two separate occasions, they are classified as having SLE. Typically it takes several years and the involvement of many clinicians to diagnose an SLE patient.

Existing laboratory tests include antinuclear antibody (ANA) testing and anti-double stranded DNA (anti-dsDNA) testing but their specificity or sensitivity is too low to support the diagnosis or classification of SLE without additional data. The OGT panel would allow for earlier and more accurate diagnosis than existing tests addressing a clear unmet medical need.

Dr Mike Evans, CEO at OGT said, “SLE is a truly debilitating disease that is particularly challenging to diagnose. Our novel diagnostic biomarker panel is more sensitive and specific than existing laboratory tests and it is our hope that, by correctly identifying the presence of SLE at an earlier stage, patients will receive faster access to the most appropriate treatment. We are pleased with the progress of our biomarker portfolio, which also includes advanced programmes in prostate and colorectal cancer, and we are currently evaluating potential partners to develop diagnostic tests based on the SLE biomarkers.”

Professor Tim Vyse, Division of Genetics and Molecular Medicine at King’s College London said: “The OGT SLE panel represents a big step forward in lupus genetic testing and the outcome of the programme so far has been very encouraging.”

OGT is also in discussions with SLE drug developers regarding potential prognostic applications of the biomarker set to predict the occurrence and frequency of relapse, or ‘flares’, so that treatment regimens can be adjusted accordingly and patient well-being maximised.

OGT and King’s will present the results of the programme at the European League Against Rheumatism (EULAR) Meeting from 12-15 June 2013 (www.eular.org).

Source: Oxford Gene Technology

Next-Generation Circulating Tumor Cell Test Demonstrates High Efficiency and Accuracy in New Study

Veridex, LLC (Veridex) recently announced that the first study of the company’s next-generation circulating tumor cell (CTC) technology, developed in collaboration with researchers at Massachusetts General Hospital (MGH), has been published in Science Translational Medicine. The collaboration, initially announced in January 2011, has led to the development of a next-generation CTC (or “liquid biopsy”) technology that offers enhanced specificity and sensitivity and enables more extensive characterization of captured cells.

The new technology tests for CTCs from the blood of cancer patients using advanced microfluidic separation techniques integrated with innovative magnetic sorting to isolate a broad spectrum of rare circulating cancer cells. This technology will allow physicians to get information about a patient’s cancer at the time treatment is being administered, one of the key components to enabling personalized medicine.

Results from the in vitro study showed the integrated system enabled the processing of large blood volumes with high throughput and efficiency, and also allowed for the ability to isolate CTCs from both epithelial and non-epithelial cancers.

In the study, the technology was used to identify the presence of CTCs in patients with cancers of the lung, prostate, pancreas, breast, as well as melanoma.

“Veridex is proud to have introduced CELLSEARCH®, the first and only FDA-cleared CTC test, and we’re excited to work with the team at Massachusetts General Hospital on our next-generation test,” said Nicholas C. Dracopoli , Ph.D., Vice President and Head of Oncology Biomarkers, Janssen Research & Development, LLC. “Together, Veridex and the MGH team bring more than 25 years of experience in rare cell technology to this project. We’re encouraged by the positive results from this study and the potential role this technology may play in helping to advance physicians’ ability to monitor their patients and develop more personalized treatment approaches.”

“These results show the possibility of its use for patients in ‘real time’ as they are receiving treatment. We hope that this next-generation CTC technology will become an everyday tool for doctors treating patients with cancer,” said Mehmet Toner , Ph.D., director of the BioMicroElectroMechanical Systems Resource Center in the Massachusetts General Hospital.

How It Works

The system used two modes of immunomagnetic sorting to isolate CTCs: a positive selection mode to identify and tag target CTCs based on expression of the epithelial surface marker EpCAM (“epithelial cell adhesion molecule”), and a negative selection mode, in which the blood sample is depleted of leukocytes by tagging them with specific antibodies. The test’s ability to isolate CTCs in this manner allows for RNA-based, single cell molecular characterization and expression analysis of CTCs. It will also allow for the test to be used in a broader range of cancers, including cells undergoing epithelial-mesenchymal transition (EMT) and cancer stem cells.

The technology integrates three sequential processes in a single automated system to capture clinically significant CTCs. First, after whole blood samples have been labeled with magnetic beads, the system separates nucleated cells, including CTCs and white blood cells, from red blood cells and platelets with minimal cell loss. Next, the system aligns nucleated cells in a single file within a sorting channel. Finally, the magnetically tagged cells are deflected into a collection channel for identification. These three integrated functions replace the need for separate cell lysis (break down), centrifugation and sorting steps.

About Circulating Tumor Cells

Circulating tumor cells are cancer cells that have detached from the tumor and are found at extremely low levels in the bloodstream. The value of capturing and counting CTCs is evolving as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy.

Study: Inertial Focusing for Tumor Antigen–Dependent and –Independent Sorting of Rare Circulating Tumor Cells

Source: PR Newswire

Rosetta Genomics Announces Acceptance for Publication of Kidney Cancer microRNA Diagnostic Manuscript by Molecular Oncology

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, recently announced that a manuscript regarding the development and validation of the Company’s microRNA-based diagnostic assay for the classification of renal cell tumors has been accepted for publication by Molecular Oncology. Yael Spector, a scientist from Rosetta Genomics, and Dr. Eddie Fridman , a pathologist and an expert in urological pathology from Sheba Medical Center in Tel-Hashomer, Israel, are the lead authors on the manuscript.

An unedited version of the manuscript is available online ahead of print publication of the final article at http://www.sciencedirect.com/science/article/pii/S157478911300046X.

The manuscript discusses the development and validation of the miRview® kidney assay, which differentiates between the four main types of primary kidney tumors: the three subtypes of renal cell carcinoma (RCC) namely clear cell, papillary and chromophobe RCC, and typically benign behaving oncocytoma. The assay was developed on a microarray platform using 181 training samples and validated on an independent set of 201 samples. The assay provided results for 92% of the validation samples, with 95% accuracy.

The topic of this manuscript will also be summarized in a poster to be presented on April 7 at the American Association for Cancer Research (AACR) Annual Meeting 2013 in Washington, D.C.

“There are an estimated 65,000 new cases of kidney cancer each year in the U.S. and more than 13,000 deaths. Distinguishing between the four main types of primary kidney tumors is critical in determining the optimal treatment regimen,” said Kenneth A.

Berlin , President and Chief Executive Officer of Rosetta Genomics. “Our miRview® kidney assay accurately classifies clear cell RCC, papillary RCC, chromophobe RCC and oncocytoma. We are delighted that this work has been accepted for publication in Molecular Oncology, an important industry trade journal.”

“The classification into subtypes of RCC has historically been less than definitive by histology, cytology and immunohistochemistry particularly in the growing context of fine needle aspirate (FNA) diagnostic specimens. The discrimination of the four subtypes can lead to the avoidance of aggressive surgical intervention in oncocytomas, and the others have differing biological behaviors that can be correlated with subtype. Importantly, newer therapeutic agents may show evidence of specificity of response by cell type. The expanded clarity of RCC diagnosis through the availability of this test will help lead to improved rationalization and optimization of new and emerging therapies, particularly in the community setting,” said Bob Wassman , M.D., Chief Medical Officer of Rosetta Genomics.

Source: PR Newswire