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The Ongoing Collaboration Aims to Exploit the High Throughput, Robustness and Ease of Use of MALDI-TOF Instruments

At the 12th HUPO World Congress, Bruker Corporation (NASDAQ: BRKR) recently announced the start of a second-phase collaboration agreement with SISCAPA Assays Technologies, Inc. (SAT). The ongoing collaboration aims to exploit the high throughput, robustness and ease of use of MALDI-TOF instruments as an alternative to nano-LC-MS technology currently used in many SISCAPA assays.

Kinexus Launches DrugKiNET KnowledgeBase with 105,000 Experimentally Tested Protein Kinase Drug Interactions

Kinexus Bioinformatics Corporation, a world-leader in the study of molecular intelligence systems, announced the launch of its DrugKiNET KnowledgeBase (www.drugkinet.ca) for the identification and development of drug candidates that potently and selectively inhibit human protein kinases. This open-access website features quantitative data on the effects of over 800 chemical compounds on more than 400 protein kinases following careful annotation of hundreds of experiments documented in the scientific literature. This data was then used to train two different proprietary algorithms to predict the inhibitory effects of 550 of these compounds on 500 human protein kinases. This information can guide biomedical researchers in the discovery of new therapeutic targets for existing drugs, and aid in the design of promising new drugs.

At least 538 different protein kinases regulate each other and another approximately 21,500 diverse protein targets to coordinate all of the operations in living cells through complex molecular communications and control networks. Kinases are well recognized by the pharmaceutical and biotech industry as highly productive targets for drug development with applications for cancer, diabetes, Alzheimer’s disease and many other diseases. In fact, over 400 human disease have been linked to genetic mutations in the genes that encode protein kinases or the direct actions of environmental toxins that target protein kinases. Over the last decade, more than two dozen kinase inhibitors have already been approved for clinical use, primarily for cancer treatment. By targeting inappropriately active kinases, these small molecule drugs essentially re-program cancer cells for their demise.

Over the last year, Kinexus and their collaborators in the Mathematics of Information Technology and Complex Systems (MITACS) groups at the University of British Columbia and Simon Fraser University have worked to identify the specific parts of different protein kinases that are critical for recognition by each of 550 different compounds that have been experimentally shown to inhibit one or more kinases. These parts, termed Inhibitor Determining Residues (IDR’s), may be involved in recognizing and binding drugs, and their identification within DrugKiNET can facilitate further optimization of even more potent and specific protein kinase inhibitory drugs. Previously, Kinexus and its partners identified Substrate Determining Residues (SDR’s) in protein kinases that were important for recognition of their protein targets and deposited this information in their open-access PhosphoNET Knowledgebase (www.phosphonet.ca).

“We believe that DrugKiNET is an extremely unique and powerful resource for the biomedical research community,” commented Dr. Steven Pelech, President and Chief Scientific Officer of Kinexus and a professor in the Department of Medicine at the University of British Columbia. “Over a third of all pharmaceutical drug development is presently focused on protein kinase inhibitory drugs, but we expect this to increase even more, since the vast majority of protein kinases have yet to be pursued as drug targets, and definition of the precise roles of different kinases in non-cancer-related diseases is still in its infancy.”

Dr. Pelech added, “We are excited by the prospect that our algorithms can define new protein kinase targets for existing drugs, and that they can identify in the genes that encode protein kinases the specific mutations that may alter their sensitivities to these drugs. As Kinexus has the capability of testing the effects of drug candidates on over 350 different purified protein kinases in-house, we also have the ability to experimentally validate many of our drug predictions for our clients.”

Kinexus is a private, biotechnology company engaged in the research and development of innovative methods to map, track and manipulate cellular communication networks. The application of this knowledge positions Kinexus and its clients in drug development, rational drug design, disease diagnosis and personalized therapies to improve human health. Kinexus currently has agreements with over 1700 research laboratories in companies, universities, government institutions and hospitals in over 35 different countries. To learn more about the diverse proteomics and bioinformatics services offered by Kinexus, please visit www.kinexus.ca or call toll-free at 1-866-KINEXUS.

Source: Kinexus Bioinformatics Corporation

Saladax Receives CLIA Laboratory Certification and Approval to Begin Clinical Laboratory Operations in Support of MyCare Portfolio

Saladax Biomedical, Inc., a privately held company developing novel diagnostic tests that individually optimize a patient’s exposure to chemotherapy, today announced it has been certified as a registered CLIA Laboratory from the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans. The CLIA certification and approval marks a significant milestone for Saladax, allowing the company to begin clinical laboratory operations for the MyCare™ portfolio of products at its facilities located in Bethlehem, PA.

Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, Inc., will initially offer testing services for chemotherapy exposure optimization assays including My5-FU™, MyPaclitaxel™ and MyDocetaxel™ in the U.S. SBL’s menu of testing services will expand to include more than a dozen new exposure optimization tests that are currently in development.

“This is a significant milestone for SBL as our CLIA laboratory operations are at the heart of our U.S. commercialization plan that will include an expanding suite of MyCare exposure optimization tests that we believe give cancer patients the edge they need with their therapy,” said Mark Myslinski, SVP and Chief Commercial Officer at Saladax Biomedical, Inc. “The SBL team did an outstanding job preparing our company for this milestone and it is illustrative of their preparedness for the commercial launch of the MyCare portfolio to oncologists in the U.S.”

Beginning on July 1, 2013, SBL will offer testing services for their initial chemotherapy exposure test portfolio, MyPaclitaxelTM, MyDocetaxelTM and the My5-FUTM test (previously OnDose) that is being transitioned from Myriad Laboratories. The MyCare technology platform offers, rapid, robust and cost-effective blood tests for patient-specific chemotherapy dose optimization.

As a simple blood test, MyCare products will provide oncologists with vital information to determine the optimal chemotherapy dose required to maximize effectiveness and limit toxicity for their patients on an individual basis.

About Saladax Biomedical, Inc.
Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. The company’s proprietary line of MyCare™ assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. The initial focus of Saladax is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. The initial portfolio of three assays is currently offered to the oncology community in markets around the world.

The company’s MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified.

Source: Saladax Biomedical

BioFocus Extends its Collaboration with The Michael J. Fox Foundation

BioFocus recently announced that it has extended its collaboration agreement with The Michael J. Fox Foundation for Parkinson’s Research, a not-for-profit organization focused on developing therapies for Parkinson’s disease. Based on the success of the project to date, BioFocus will continue the optimization of agents for disease specific biomarkers.

“We have worked with The Michael J. Fox Foundation since 2011 to identify and optimize alpha-synuclein imaging agents, and are delighted that the progress supports an extension to this collaboration,” said Dr Chris Newton, Managing Director, BioFocus. “The program will utilize BioFocus’ leading biology and chemistry platforms, and will capitalize on the company’s highly experienced teams and state-of-the-art technologies.”

Source: BioFocus

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