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ASCO and the CAP Release Updated Guideline on HER2 Testing in Breast Cancer

The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) recently issued a joint, updated guideline aimed at improving the accuracy and reporting of human epidermal growth factor receptor 2 (HER2) testing in patients with invasive breast cancer. The guideline update is based on a systematic review of medical research literature, providing oncologists and pathologists with detailed recommendations for how to test for HER2 overexpression, interpret the results, and recommend HER2-targeted therapies. The guideline, originally issued in 2007, is being published in ASCO’s Journal of Clinical Oncology (JCO) and the CAP’s Archives of Pathology & Laboratory Medicine. The joint guideline was prepared by an ASCO/CAP Update Committee consisting of experts in breast cancer and cancer biomarkers.

NanoString Technologies Receives FDA 510(k) Clearance for Prosigna Breast Cancer Prognostic Gene Signature Assay

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Based on the PAM50 gene signature, Prosigna is the company’s first FDA-cleared in vitro diagnostic assay and uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay is performed using the nCounter® Dx Analysis System, which can be placed in qualified laboratories throughout the United States, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients.

“Receipt of FDA 510(k) clearance for Prosigna marks a key milestone for NanoString and is an important step forward in the treatment of breast cancer. This achievement is a testament to the ongoing dedication and professionalism of our team, and the commitment of our collaborators,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Prosigna illustrates our approach of using nCounter technology to translate genomic discoveries into powerful in vitro diagnostic products, and it represents a significant growth opportunity beyond our robust life sciences research business.”

The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years, and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score, or ROR Score, in the scientific literature, including the TransATAC study recently published in the Journal of Clinical Oncology ) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate or high risk, while node-positive patients are classified as low or high risk.

Other key features of the Prosigna Breast Cancer Prognostic Gene Signature Assay include:

  • All-in-one assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
  • High-throughput workflow allowing each nCounter Dx Analysis System to process up to 30 patient samples per eight hour work day
  • Automated generation of personalized full-color patient reports that can be quickly and easily shared electronically with ordering oncologists

Bruce Seeley, Senior Vice President & General Manager of Diagnostics of NanoString Technologies commented: “We believe that the compelling clinical data, clear patient reporting, and unique delivery model position Prosigna for success in the U.S. market. By integrating the Prosigna Assay into existing laboratory workflows, we are offering physicians and patients seamless and timely access to clinical insights and a powerful tool that can aid in making more informed treatment decisions.”

Prosigna-enabled nCounter Dx Analysis Systems are expected to be available for placement in high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified laboratories late in the fourth quarter of 2013. Prosigna testing services are expected to be available through qualified U.S. clinical laboratories beginning in the first quarter of 2014.

Source: NanoString Technologies

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

Article Highlights the Value of PreDx Testing of Prediabetic Patients in the Primary Care Setting

An article published in Clinical Diabetes describes the clinical value of PreDx testing for more effective management of prediabetes patients in the primary care practice setting. The PreDx test is a predictive multi-biomarker fasting blood test developed by Tethys Bioscience, Inc., that stratifies adult patients with prediabetes into low, moderate or high risk categories for developing type 2 diabetes within 5 years. In addition to enabling the more cost‐efficient allocation of healthcare resources toward those prediabetes patients at highest risk of progression, PreDx has also been shown to be an effective tool for monitoring the impact of lifestyle interventions in reducing the likelihood of developing the disease.

Authored by primary care practitioners Paul Rich, MD and Charles Shaefer, MD, endocrinologist Steven Edelman, MD, and Chris G. Parkin, MS, the article discusses how PreDx testing helps health care providers overcome two important obstacles that hinder more effective diabetes prevention efforts in the primary care setting – the inability of current assessment tools to differentiate prediabetes patients based on risk of progression, and the constraints on physician time and resources. A review of published literature regarding the clinical validity of PreDx for the risk-based stratification of prediabetes patients and the monitoring of their response to interventions is accompanied by case studies that illustrate the authors’ experiences with the test in their practices, and concludes with a four-step process to help clinicians effectively integrate the PreDx test into their prediabetes management protocols.

The authors summarized their experiences with PreDx testing as follows:

Paul Rich, MD: “Our experience with PreDx testing has illustrated its value as a practical means to achieve greater success in diabetes prevention at the primary care level. Unlike other lab tests that give us more numbers to consider, PreDx interprets those results for us, generating a predictive score that identifies our most vulnerable prediabetes patients, and helps guide our management strategies for those patients. That saves us time, optimizes how we use our resources, and gives our patients a better chance of avoiding a very bad disease. No other test does that.”

Charles Shaefer, MD: “The insights we get with PreDx, in terms of who to treat more intensively and how well they’re responding to those interventions, have enabled us to make more-informed treatment decisions that produce better outcomes, as demonstrated by the results achieved in our case studies.”

Steven Edelman, MD: “An added advantage of PreDx is the motivational impact their score has on patients who have resisted dealing with their diabetes risk despite previous warnings. Somehow, a personalized numerical score, that presents their risk on a scale of 1 to 10, gets through to them, and prompts them to take action to lower their risk by making healthier lifestyle choices.”

Juan Frias, MD, Chief Medical Officer for Tethys Bioscience and a practicing endocrinologist, commented on how the review article could help enhance the use of the PreDx test, especially given the recent launch of a fingerstick option for blood collection. “PreDx is a valuable clinical tool that, until recently, has only been accessible to practices with in-practice phlebotomy capabilities. The flexibility to perform the test with either venous or capillary blood means that many more practices will be able to offer PreDx to their prediabetes patients, and benefit from the unique clinical utilities it offers.”

Study: Using a Quantitative Measure of Diabetes Risk in Clinical Practice to Target and Maximize Diabetes Prevention Interventions

Source: PR Newswire

Kantar Health Launches CancerMPact Biomarker Analysis

Kantar Health, a leading global healthcare consulting firm, today announced the availability of CancerMPact® Biomarker Analysis, a global offer that examines biomarker segmentation in the current and evolving oncology landscape. The analysis is based on a thorough review of literature and recently published data covering the following biomarkers:

  • BRAF (melanoma)
  • EGFR (non-small lung cancer)
  • EML4-ALK (non-small cell lung cancer)
  • KRAS (colorectal cancer)
  • TNBC (breast cancer)

CancerMPact Biomarker Analysis helps clients identify the percentage of cancer patients with a specific biomarker; ascertain variations in biomarker prevalence by race, ethnicity or geography; determine which information to use to inform forecasting and market sizing; and pinpoint which patient segments are available for targeted therapies and clinical trials. Through this new offer, pharma companies are able to better understand which patient subpopulations are candidates for unique treatment options in this complex therapeutic area.

“The era of ‘personalized’ medicine has arrived, and while physicians and patients are ready to embrace it, many factors need to be considered by a manufacturer to accurately evaluate their market opportunities,” Kantar Health Vice President David Robinson said. “We estimate that 17 to 20 percent of oncology patients are currently eligible for personalized care due to either biomarkers or histology-based treatments. This number will grow in the near future as more biomarkers are validated and new patient subpopulations are identified as being appropriate for novel targeted therapeutics.”

CancerMPact Biomarker Analysis is produced by the same oncology experts as CancerMPact®, which has become an invaluable oncology decision support tool for market analysis, strategic planning and identification of commercial opportunities in the U.S., Western Europe, Japan and China. This tool, composed of web-based integrated modules, includes Treatment Practices and Evolution (Treatment Architecture and Future Trends and Insights), Patient Metrics, and Monthly Drugs and Regimens.