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Study Published Showing Advantages of the PAM50 Gene Signature, the Basis for Prosigna, in Helping to Estimate Risk of Late Distant Recurrence in Postmenopausal Estrogen Receptor Positive Breast Cancer Patients

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that a study published online in the Journal of the National Cancer Institute demonstrated that the PAM50 gene signature, which is the basis for the Prosigna™ Breast Cancer Prognostic Gene Signature Assay, provides important information to help estimate the risk of late distant recurrence in postmenopausal women with estrogen receptor positive (ER+) early-stage breast cancer. After comparing the PAM50 gene signature, the Oncotype DX® Breast Cancer Assay and the IHC4 score, the authors concluded that the PAM50 gene signature provided the strongest prognostic information regarding risk of distant recurrence five to 10 years following diagnosis in postmenopausal ER+ early-stage breast cancer patients treated with five years of endocrine therapy.

Researchers Develop Rapid, Cost-effective Early Detection Method for Organ Transplant Injury

A recently reported blood test for the early detection of organ transplant injury could enable more timely therapeutic intervention in transplant patients and thus help to avoid longer term damage. As described by scientists at the University Medical Center Göttingen and Chronix Biomedical, a molecular diagnostics company, the new method uses Bio-Rad Laboratories’ Droplet Digital PCR (ddPCR™) technology to overcome the obstacles of earlier tests, which were both time-consuming and costly. The method was presented at the American Association of Clinical Chemistry (AACC) 2013 annual meeting and has been accepted for publication in Clinical Chemistry.

Approximately 28,000 organ transplantations (known as grafts) are performed each year in the U.S., with another 100,000 patients on waiting lists. However, transplant patients are often subject to organ rejection: acute rejection of liver transplants within three years is nearly 22 percent, while heart and lung rejection is close to 50 percent. In addition, nearly half of all of kidney transplants fail within 10 years.

Graft-derived cell-free DNA (GcfDNA) in the circulation of transplant recipients is a potential rejection biomarker. But previous attempts to determine GcfDNA, which require parallel sequencing of donor and recipient DNA, are expensive and require a long turnaround and use of donor DNA. University Medical Center Göttingen and Chronix Biomedical researchers sought to develop a new method in an attempt to address these drawbacks.

Using ddPCR for Fast, Cost-Effective Test

The researchers applied Bio-Rad’s ddPCR technology to quantify graft-derived cfDNA in recent liver transplant patients and in stable patients who had undergone a transplant procedure more than six months earlier. ddPCR technology allowed them to develop a cost-effective and fast laboratory test that detects cfDNA being released into the blood stream by dying cells from the transplanted organ.

“GcfDNA from dying graft cells are the most direct and sensitive indicator of organ rejection and we needed an instrument that could measure it,” said Chronix Biomedical’s Chief Technology Officer and the study’s senior author, Ekkehard Schuetz, MD, PhD. “ddPCR added an additional level of reliability and precision to traditional PCR.”

Sequencing methods typically require batch sampling, but by using ddPCR, researchers are able to run single samples. Additionally, this method is reducing test time from three days or more to one day and costs by 90 percent. The study authors were able to address the need for donor DNA by preselecting SNPs that ensure enough heterogeneity between donor and recipient. The new blood test can also deliver results up to several days before the conventional aspartate aminotransferase (AST) and bilirubin tests for liver transplantation rejection, with the potential for an immediate positive impact on patient care.

“We will now be able to detect subclinical rejection and early intervention may allow us to avoid a full-blown rejection,” said Michael Oellerich, M.D., FACB, FRCPath and Lower Saxony Distinguished Professor of Clinical Chemistry at the University Medical Center Göttingen and study Principal Investigator. “This test may be useful to personalize immunosuppression and to improve long-term outcomes.”

“Detecting non-host cfDNA is the third example for the commercial potential of cfDNA diagnostics. Researchers will now be able to extend the applications from fetal cfDNA in maternal blood and personalized biomarkers for minimal residual disease in cancer to solid organ transplantation,” said Howard Urnovitz, PhD, Chronix Biomedical’s Chief Executive Officer.

“We are looking forward to the improvements in precision medicine we can offer with ddPCR and this example in transplantation highlights the diagnostic value for the technology,” said Paula Stonemetz, Director Diagnostic Business Development, Digital Biology Center, Bio-Rad Laboratories.

The researchers were awarded a National Academy of Clinical Biochemistry (NACB) Distinguished Abstract Award at the 2013 AACC annual conference. The results are part of a larger planned study to determine if cfDNA is the earliest indication of a transplant organ rejection.

Source: EurekAlert!

University of Maryland, Baltimore’s Licensing Deals Fuel Local Life Sciences Community

University of Maryland (UM) Ventures recently announced agreements between University of Maryland, Baltimore (UMB) and five different life sciences companies across the Baltimore/Washington metropolitan region. The companies include Montgomery County-based Rexahn Pharmaceuticals, Baltimore County-based Plasmonix, Prince Georges County-based IGI Technologies, Howard County-based A&G Pharmaceuticals, and Frederick County-based BioAssay Works. These deals are part of UM Ventures’ continual efforts to accelerate technology commercialization, advance industry collaboration, and support projects with commercial value at both the Baltimore and College Park campuses of the university.

“UMB is very excited to collaborate with these companies, each an innovator in its own right,” said Phil Robilotto, Assistant Vice President, Office of Technology Transfer, UMB. “These types of collaborations are at the core of our mission to channel the expertise of our industry partners and highlight our efforts to support the Maryland biotechnology community.”

UMB/Rexahn Exclusive License Agreement: In June 2013, UMB and Rexahn Pharmaceuticals, a clinical-stage biopharmaceutical company developing the next generation of cancer drugs, executed an exclusive license agreement for a novel drug delivery platform, Nano-Polymer-Drug Conjugate Systems (NPDCS), which was co-developed by researchers with the University of Maryland (UM) School of Pharmacy in the Department of Pharmaceutical Sciences, including Assistant Professor Anjan Nan, Ph.D. Rexahn’s platform uses existing chemotherapeutic agents, delivering them directly into cancer tumors. The UMB/Rexahn collaboration began after the company and a team of UMB researchers received a Maryland
Industrial Partnership (MIPS) award. The MIPS program is aimed at technology acceleration, providing funds that are matched by Maryland companies to support university-based research.

UMB/Plasmonix License Agreement: Also in June 2013, UMB entered into a license agreement with Plasmonix for a pathogen detection technology. Plasmonix focuses on the enhancement of luminescent signals through advanced use of metal nanoparticles, applying its technology in life science and diagnostic assays. Joseph Lakowicz, Ph.D., Professor of Biochemistry & Molecular Biology within the UM School of Medicine, invented the licensed UMB technology. His laboratory focuses on advancement of fluorescence compositions and methods for use in both research and commercial applications.

UMB Option Agreements with IGI Technologies/A&G Pharmaceuticals: UMB also executed option agreements (giving each company the exclusive right to evaluate a university technology for a short period of time prior to executing a full license agreement) during June 2013 with IGI Technologies and A&G Pharmaceuticals, both university start-ups, although at different stages of company development. Founded by Raj Shekhar, Ph.D., and William Plishker, Ph.D., former UM School of Medicine researchers from the Department of Diagnostic Radiology, IGI Technologies is an emerging start-up developing high-speed medical image registration technology through a Phase II Small Business Technology Transfer (STTR) award from the National Institutes of Health (NIH). A&G Pharmaceuticals, which was founded as a UMB startup in 2007, is discovering and developing theranostics (drug/test combinations) that improve screening, detection, and treatment of cancer. The company also offers custom antibody development through its service division – Precision AntibodyTM. UMB’s option agreement with A&G Pharmaceuticals is to explore the potential for the company’s development of a new cancer diagnostic test based on the tissue biomarker research of lead inventor Yun Qiu, Ph.D., Professor of Pharmacology, UM School of Medicine.

UMB/BioAssay Works Commercial Evaluation and Option Agreement: In September 2012, UMB entered into a commercial evaluation and option agreement with BioAssay Works to evaluate a Staph aureus diagnostic technology based on the work of lead inventor, Mark E. Shirtliff, Associate Professor, Department of Microbial Pathogenesis, with a dual appointment in UM Schools of Dentistry and Medicine. Dr. Shirtliff studies bacterial biofilms, a mode of growth where pathogens such as Staph aureus become resistant to conventional therapy. He was
awarded the 2013 BioMaryland LIFE Prize for his promising Staph vaccine work. BioAssay Works focuses on antibody-based and antigen-based detection technologies, and on their application in lateral-flow immunoassay. The partnership between BioAssay Works and UMB may lead to the development of a rapid and sensitive test for Staph, in particular the treatment-resistant type (“MRSA”).

Since UM Ventures launched in 2012, the University has helped faculty entrepreneurs manage and commercialize their discoveries, and has helped student entrepreneurs participate in and lead real-world early-stage business ventures. UMB and UMCP startups include a wide range of success stories. UM Ventures provides resources, funding, and expertise to help startups bring innovative technologies to the market.

Source: University of Maryland

Novel Use of Pressure BioSciences’ Patented PCT Platform Offers New Insights into Protein Structure and Function, New Tool for Biomarker Discovery and Rational Drug Design

Last month, Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” and the “Company”) announced that data supporting important advantages of PBI’s powerful and enabling Pressure Cycling Technology (“PCT”) platform were presented at the 27th Annual Symposium of the Protein Society held July 20-23, 2013 in Boston, Massachusetts.

The use of highly sophisticated analytical instrument systems by research scientists worldwide has resulted in a greater understanding of complex biological molecules, including proteins – the “building blocks of life.” One such instrument system, Electron Paramagnetic Resonance (“EPR”) spectroscopy, has been shown to provide key information on the structure, flexibility, and function of proteins. This information is crucial to the development of new and better diagnostics, therapeutics, and vaccines.

At this year’s annual Protein Society symposium, researchers from UCLA reported on the development of an improved EPR system based on the use of high pressure. This novel system combined (for the first time ever) two cutting-edge EPR methods: site directed spin labeling (“SDSL”) and double electron-electron resonance (“DEER”). This strategy allowed the investigation of dynamic events in proteins that would be difficult or even impossible to study by conventional EPR technology.

Dr. Wayne L. Hubbell, Distinguished Professor of Chemistry and Biochemistry and Jules Stein Professor of Ophthalmology at UCLA, and senior author of the study, commented: “The study of proteins under pressure by EPR and other spectroscopic techniques, such as Nuclear Magnetic Resonance (“NMR”), has the potential to greatly improve our understanding of the structure and function of proteins. This information could subsequently provide new insights into such important areas as biomarker discovery and rational drug design, and play an important role in the discovery process that lies ahead in the exciting field of protein science.”

Richard T. Schumacher, President and CEO of PBI, said: “We believe these and other data reported by researchers using pressure-based EPR and NMR systems strongly indicate that PCT can enhance the recovery, detection, and measurement of proteins from a wide variety of samples. In turn, this information has the potential to help accelerate the design and manufacture of new and better diagnostics, therapeutics, and vaccines. We further believe that the advantages of pressure-based spectroscopic methods are just now beginning to be realized by scientists, and that as the body of data continues to grow from high pressure-based spectroscopic studies, that PBI has the potential to become a major provider of high pressure equipment into the exciting and growing spectroscopy area.”

Source: Pressure BioSciences

Cancer Research Implies Future for Personalized Medicine, Reduction in Animal Testing

On August 6th, JoVE, the Journal of Visualized Experiments, published two new methods for scientists to study and treat tumor growth. The methods introduce a lab-born, human tissue structure with replicated human biochemistry – offering scientists the opportunity to grow, observe, and ultimately learn how to treat biopsied human tumor cells.

The University Hospital of Würzburg scientists behind the experiment have created a new version of the testing structures known as biological vascularized scaffolds (BioVaSc). Their three-dimensional human-tissue structures are the first of their kind to be built with multiple human cell types. The structures offer two methods for study: a three-dimensional (3D) static system for short term testing that is beneficial for microscopy imaging, and a dynamic system that introduces a flow-simulation to simulate actual conditions of the human body. This is especially helpful in long term studies of metastasis, or, the spreading of cancer cells through the human vascular system.

“Our 3D tumor model is reducing or even replacing animal experiments,” said engineer Jenny Reboredo. In their article, Reboredo and her colleagues explained that this human-tissue based testing system could eliminate the potential for the misinterpretation that often accompanies animal testing. Furthermore, this method solves the shortfalls of typical in-vitro testing, which is limited by the lack of intercellular interactions.

The authors also suggest that their use of primary cells derived from tumor biopsies is a “very important step towards personalized medicine.” With the method the team has created, a lab could in the future take a biopsy of a cancer cell and do tests to find the most effective treatment before ever administering drugs to the human patient.

Further implications of Reboredo and her colleagues’ work involve the use of a BioVaSc-type method for studying non-tumorous diseases. “In the long term we want to be able to develop disease models, especially for diseases where no animal models are available,” Reboredo said.

When asked why she and her colleagues published in JoVE, Reboredo noted that their models “can be explained and visualized best in a movie [and] to publish in such a media is made possible by JoVE.”

Source: EurekAlert!