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Definiens to Host the First International Symposium for Tissue Phenomics This Fall

Definiens, the global leader in Tissue Phenomics™ for oncology diagnostics, recently announced that registration is now open for the company’s inaugural conference, The International Symposium for Tissue Phenomics. Alongside genomics, Tissue Phenomics is a key driver in the growth of personalized medicine, and the symposium brings together thought leaders from around the globe on companion diagnostics, immunotherapy, and tissue-based patient stratification for personalized medicine. The Symposium will begin with a keynote lecture from Nobel Laureate, Gerd Binnig, Ph.D., discussing his approach to uncovering novel diagnostics through using big data in tissue.

Genomic Health Announces Presentation of Oncotype DX Studies Reinforcing Value of Tests in Guiding Treatment for Multiple Cancers

Genomic Health, Inc. (Nasdaq: GHDX) recently announced results from four studies highlighting the value of its Oncotype DX® tests for optimizing treatment for patients with breast and colon cancer. Three new decision impact studies – including the company’s first international decision impact study in colon cancer and additional evidence for the Oncotype DX breast cancer test’s significant impact on breast cancer treatment decisions in the United Kingdom (UK) – were among data presented at the European Cancer Congress 2013 in Amsterdam. The results were presented on the heels of the recent National Institute for Health and Care Excellence (NICE) guidance announcement that recommended the use of Oncotype DX “as an option to help clinicians decide whether to prescribe chemotherapy in people with early breast cancer.”

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

Study Published in The Journal of Clinical Oncology Demonstrates Advantages of NanoString’s Prosigna Breast Cancer Assay

NanoString Technologies, Inc. (NASDAQ: NSTG), a provider of life science tools for translational research and molecular diagnostic products, recently announced that the TransATAC clinical validation study for its Prosigna Breast Cancer Prognostic Gene Signature Assay, which is based on the PAM50 gene signature, was published in the Journal of Clinical Oncology (JCO). This study, portions of which were initially presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, evaluated the ability of three breast cancer tests to predict risk of distant recurrence after endocrine therapy in postmenopausal women with hormone receptor-positive (HR+) early-stage breast cancer. The authors of the study concluded that the PAM50-based assay provides more prognostic information in endocrine treated patients with HR+ node negative disease than Oncotype DX®, with better differentiation of intermediate and high-risk groups.

The study included 1,017 samples from the landmark ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial of postmenopausal women with HR+ early-stage breast cancer treated with five years of endocrine therapy. The study was performed on RNA extracted from tumor samples by Genomic Health, Inc. for validation of the Oncotype DX® Breast Cancer Assay. The goals of the TransATAC study were to determine if the PAM50 gene signature added prognostic information to clinical-pathological variables and to compare the performance of the PAM50 risk of recurrence (ROR) score, the Oncotype DX recurrence score (RS), and the IHC4 score, derived from immunohistochemical assessment of ER, PR, HER2 and Ki67 genes, in indicating risk of distant recurrence after endocrine therapy. All primary and secondary endpoints of the study were met.

Authors of the study reported that the PAM50 ROR score added prognostic information about the risk of 10-year distant recurrence in addition to that provided by standard clinical-pathological variables in the analysis of all patients studied (p < 0.001). Similar results were achieved in all three prospectively defined clinically important subsets of patients: node-negative (p < 0.001), node-positive (p = 0.002), and HER2-negative (p < 0.001). In addition, the study reported that patients with Luminal A subtype had a lower risk of recurrence than those with the Luminal B subtype further supporting the biological differences between these groups. The authors also concluded that the PAM50 ROR score provided more prognostic information than the widely used Oncotype DX RS. Compared to Oncotype DX RS, PAM50 ROR score categorized fewer patients as intermediate-risk and more as high-risk when using prospectively defined risk cutoffs for low, intermediate and high risk of <10%, 10% to 20% and >20% estimated risk of recurrence, respectively. Moreover, the authors concluded that the PAM50 ROR score provided at least as much information as the IHC4 and may provide more information than IHC4 in the node negative/HER2 negative patient group.

“The publication of the TransATAC study is an important milestone in our ongoing effort to enable genomic testing for breast cancer in local laboratories worldwide,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “We look forward to discussing the results and conclusions of this study with oncologists, pathologists, and payers in the European Union and other countries that recognize the CE Mark, as we continue with our commercial launch in those regions.”

Study: Comparison of PAM50 Risk of Recurrence Score With Oncotype DX and IHC4 for Predicting Risk of Distant Recurrence After Endocrine Therapy

Source: Business Wire

Precision Therapeutics Announces Topline Prospective Clinical Data Demonstrating Significant Improvement in Overall Survival and Progression Free Survival in Recurrent Ovarian Cancer using Personalized Chemotherapy Diagnostic ChemoFx®

Precision Therapeutics, Inc., a life science company that develops and markets personalized medicine products for individualizing cancer care, recently announced results from a nine-year, multi-center, blinded prospective clinical study which demonstrated statistically significant improvement in overall survival and progression free survival in 262 patients with recurrent ovarian cancer whose tumors were tested with ChemoFx®, a personalized chemotherapy diagnostic.

Recurrent ovarian cancer patients in the clinical study who were treated with a chemotherapy drug identified to be responsive by the ChemoFx assay experienced a statistically significant improvement of 50% in overall survival, versus those patients treated by drugs classified as resistant by ChemoFx. The study also showed statistically significant improvement in progression free survival. In the clinical study, ChemoFx was able to identify at least one sensitive chemotherapy drug for more than half of the recurrent ovarian cancer patients studied, approximately doubling the statistics that show only 25 to 30 percent of cancer patients with recurrent ovarian cancer benefit from a chemotherapy treatment chosen empirically.1 These topline results were presented at a medical symposium and in a poster session held during the Society of Gynecologic Oncology (SGO) Annual Meeting on March 9-12, 2013 in Los Angeles, California.

“This clinical study is a landmark for the treatment of ovarian cancer because it is the first prospective data that definitively shows that a personalized diagnostic test can make a significant clinical impact by improving overall survival by 50% in women with this devastating cancer,” said Thomas J. Rutherford MD, PhD, Professor of ObGyn and Reproductive Sciences and Section Chief, Gynecologic Oncology at the Yale School of Medicine, and lead investigator in the ChemoFx clinical study.

“We see ChemoFx as an example of the power of personalized cancer diagnostics that put innovative technology in the hands of physicians to help inform treatment decisions, with the ultimate goal of improving patient outcomes,” said Sean McDonald, President and CEO of Precision Therapeutics. “We are excited to bring our late-breaking data to share with the treatment community at the SGO meeting, and look forward bringing ChemoFx to all gynecologic patients through the 1,000 board certified treating gynecologic oncologists in the US. We believe this test will have a profound impact on the treatment of this dreadful disease.”

Patients in the study’s treatment group had their cancer cells tested with ChemoFx to assess tumor response among 12 to 15 clinically equivalent chemotherapy options that National Comprehensive Cancer Network (NCCN) cancer guidelines recommend for persistent or recurrent ovarian cancer. ChemoFx was confirmed as an independent predictive factor for progression free survival and overall survival per multivariate Cox proportional hazards analysis. The company expects to publish comprehensive data from the clinical study in the near future.

“The results of this prospective study suggest that ChemoFx may serve as an important tool in selecting more effective drugs to improve the outcome of recurrent ovarian cancer patients,” said John Chan, MD, Associate Professor, Division of Gynecologic Oncology, University of California at San Francisco, Helen Diller Family Comprehensive Cancer Center. “This late breaking data on the utility of assay-directed treatment with ChemoFx will move us forward toward more personalized treatment for ovarian cancer.”

“With a devastating cancer, like ovarian cancer, which has an extremely high recurrence rate in 70% to 90% of patients, it is a groundbreaking moment when there is new clinical data, like these data with ChemoFx, showing that we have a chance to dramatically improve treatment for many patients,” said Thomas Krivak, MD, Associate Professor, University of Pittsburgh Physicians Magee Gynecologic Cancer Program, and an investigator in the ChemoFx clinical study.

“We have seen modest improvements in long-term survival for women with ovarian cancer in the past two decades, despite the availability of several new drugs and treatment strategies.

The data from this multi-institution, blinded observational clinical trial with ChemoFx is a highly significant advancement in understanding how the biology of each patient’s tumor may hold answers for treatments that could result in improvements in survival beyond what we are seeing currently,” said Robert Holloway, MD, Medical Director of Florida Hospital Gynecologic Oncology. “Furthermore, the significance of this study from a clinical standpoint is that this test may have predictive abilities, enabling a physician to choose the most effective pharmaceutical treatment from among the available options for ovarian cancer.”

Source: Business Wire