Biomarker Bulletin is an occasionally recurring update of news focused on biomarkers aggregated at BiomarkerCommons.org. Biomarkers are physical, functional or biochemical indicators of normal physiological or disease processes. The individualization of disease management — personalized medicine — is dependent on developing biomarkers that promote specific clinical domains, including early detection, risk, diagnosis, prognosis and predicted response to therapy.

• Selventa Receives Patent for Method to Identify Biomarker Profiles

  Selventa, a biomarker discovery company that enables personalized healthcare through the stratification of patients based on disease-driving mechanisms, recently announced a US patent that relates methods and techniques that facilitate discovery of biomarkers, thus aiding in the development of predictive and prognostic diagnostic tests for therapeutics targeting complex multi-factorial diseases.

• Biomarker Discovery: Moving Diagnostics to the Forefront of Medical Research

  Increasing emphasis is being placed on biomarker discovery as the key to advancing personalized medicine.

• FDA Clears Critical Diagnostics Presage ST2 Assay for Patients with Heart Failure

  Critical Diagnostics is a U.S.-based biomarker company focused on optimizing patient care in cardiovascular diseases, such as heart failure.

• SciClips Launches Cancer Biomarker Database

  The success of personalized cancer therapeutics relies on the development of companion diagnostic assays that can identify the most appropriate cancer patient, tumor type and disease state. To address this need, SciClips, a Wisconsin-based open innovation platform company that enables scientists and researchers to collaborate and share research and ideas, recently launched a cancer (oncology) biomarker database.

• The Bill & Melinda Gates Foundation to Fund Biomarkers of Gut Function for Global Health

  The Bill & Melinda Gates Foundation is currently seeking letters of inquiry for the grant program Biomarkers of Gastrointestinal (Gut) Function and Health.

Biomarker Bulletin is an occasionally recurring update of news focused on biomarkers aggregated at BiomarkerCommons.org. Biomarkers are physical, functional or biochemical indicators of normal physiological or disease processes. The individualization of disease management — personalized medicine — is dependent on developing biomarkers that promote specific clinical domains, including early detection, risk, diagnosis, prognosis and predicted response to therapy.

• Recent Advances in Biomarker Discovery for Parkinson’s disease, a Satellite Symposium at the Society for Neuroscience Annual Meeting

  A satellite symposium, Recent Advances in Biomarker Discovery for Parkinson’s Disease, is being sponsored by Covance on November 13th, 2011 at the Society for Neuroscience Annual Meeting in Washington, D.C.

• NYAS Symposium: Biomarkers and Brain Imaging of Presymptomatic Alzheimer’s Disease

  The New York Academy of Sciences (NYAS) will be holding an afternoon event in January 2012 that focuses on biomarkers and brain imaging of presymptomatic Alzheimer’s disease.

• NIH to Support Clinical Trial Implementation or Biomarker Clinical Evaluation Studies

  Earlier this month, the National Institutes of Health announced that the National Institute of Dental and Craniofacial Research (NIDCR) Institute will support mission-relevant investigator-initiated Phase I, II, III or IV clinical trial cooperative agreement applications or biomarker evaluation studies that require prospective collection of clinical outcomes and clinical specimens.

• NIH to Fund Studies that Adapt Adult Biomarkers to Children

  The National Institutes of Health announced Thursday that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will support studies that propose adapting adult biomarkers to children.

• CLC bio to Develop Bioinformatics Tools for Prostate Cancer Biomarker Project

  CLC bio is participating in a $4 million Danish collaboration focused on the identification and validation of biomarkers of prostate cancer risk and aggressiveness.

Biomarker Bulletin is an occasionally recurring update of news focused on biomarkers aggregated at BiomarkerCommons.org. Biomarkers are physical, functional or biochemical indicators of normal physiological or disease processes. The individualization of disease management — personalized medicine — is dependent on developing biomarkers that promote specific clinical domains, including early detection, risk, diagnosis, prognosis and predicted response to therapy.

• Biomarker Commons Named World Companion Diagnostics Summit Media Partner

  Diagnostics used to select patients for treatment with a particular therapeutic or determine what and/or how treatment will be administered have been termed companion diagnostics. Companion diagnostics hold great promise for personalized medicine. A companion diagnostic is a biomarker(s) used in a specific context that provides biological and/or clinical information that enables better decision making about the development and use of a potential therapeutic. Given the significance of companion diagnostics, I’m proud to announce Biomarker Commons’ first media partnership with the 4th World Companion Diagnostics Summit.

• Personalized Medicine or Patient-centered Care?

  Personalized medicine is a term used in science and medicine that holds significant promise of administering medicines specifically tailored to an individual’s genome or metabolism. However, an editorial published yesterday in the Canadian Medical Association Journal (CMAJ) suggests that the term creates an image for the public that is completely opposite of science and technology and sets up unrealistic expectations.

• FDA, EMA Seek Input on Companion Diagnostics, Genomic Biomarkers

  Regulators in the U.S. and Europe have each posted requests for public comment on issues affecting the development of medicines by drug companies.

• FDA Issues New Guidelines on Clinical and Nonclinical Genomic Biomarkers

  The U.S. Food and Drug Administration (FDA) has issued new guidelines on biomarkers related to drug or biotechnology product development. The guidance was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

• Neuroimaging Identifies an Endophenotype and Candidate Biomarker for Autism

  In response to facial expression of emotional, a similar pattern of brain activity is observed in both people with autism and their unaffected siblings. Researchers from the University of Cambridge recently used functional magnetic resonance imaging (fMRI), a specialized MRI scan used to measure the change in blood flow related to neural activity in the brain, to show that reduced activity in areas of the brain associated with empathy and face processing is a candidate biomarker for familial risk of autism. The findings were published online recently in the journal Translational Psychiatry.

Biomarker Bulletin is an occasionally recurring update of news focused on biomarkers aggregated at BiomarkerCommons.org. Biomarkers are physical, functional or biochemical indicators of normal physiological or disease processes. The individualization of disease management — personalized medicine — is dependent on developing biomarkers that promote specific clinical domains, including early detection, risk, diagnosis, prognosis and predicted response to therapy.

• TCGA Study Brings Ovarian Cancer Patients Closer to Personalized Medicine

  In the June 30 issue of Nature, researchers from The Cancer Genome Atlas (TCGA) Research Network provide a large-scale integrative report on genetic mutations and pathways that distinguish the most common and aggressive type of ovarian cancer from other types of ovarian cancer as well as from other solid tumors. The disease is not defined by one or few cancer-driving genes but rather numerous mutations that individually occur in only a small number of cases. Given the degree of genomic disarray, the study results suggest that genomic structural variation is the driver of ovarian cancer. The findings may be helpful in guiding physicians to choose experimental treatments that are most likely to target molecular alterations effectively in patients with high-grade serous ovarian adenocarcinoma.

• BGI Expanding Proteomics Services to Include Mass Spectrometry

  Earlier this month, Adam Bonislawski at GenomeWeb’s Proteomonitor reported that China-based BGI intends to expand its proteomics offerings and buy ~50 new mass spectrometers over the next two years. This diversification into clinical and drug-development services is a forward-thinking move for the genomics/bioinformatics giant and one that should be taken seriously by current proteomics service providers.

• DHMRI Establishes Immune Monitoring Laboratory for Biomarker Discovery and Development

  Last week, the David H. Murdock Research Institute (DHMRI) announced that it acquired the Immune Tolerance Institute, Inc. (ITI) as a next step in its continued growth. The DHMRI provides integrated, state-of-the-art genomic, cellular, proteomic and bioinformatics technology platforms as a major resource for a range of academic and industry partners undertaking both preclinical and clinical research.

• NINDS to Fund Biomarker Clinical Study for Spinal Muscular Atrophy

  Earlier this month, the National Institute of Neurological Disorders and Stroke (NINDS) announced a funding opportunity and invited applications for a study of candidate biomarkers in Spinal Muscular Atrophy (SMA). The goals of the SMA biomarker validation study are to: (1) evaluate biomarkers and clinical outcomes longitudinally across a spectrum of SMA cases; (2) establish a clinical outcomes and biomarker database; and (3) contribute samples to the NINDS biorepository at the Coriell Institute for Medical Research to capture and share methods and pre-competitive data.

• SciClips Launches Biomarker and Drug Discovery Protocols Database

  SciClips is an open innovation platform that enables scientists and researchers to collaborate and share research and ideas. Following up on a diagnostic and prognostic biomarker database released earlier this year, SciClips has launched a second database constisting of biomarker and drug discovery research protocols.

Biomarker Bulletin is an occasionally recurring update of news focused on biomarkers aggregated at BiomarkerCommons.org. Biomarkers are physical, functional or biochemical indicators of normal physiological or disease processes. The individualization of disease management — personalized medicine — is dependent on developing biomarkers that promote specific clinical domains, including early detection, risk, diagnosis, prognosis and predicted response to therapy.

• Results of Highly Cited Biomarker-disease Associations Often Overestimated

  Although new biomarkers are regularly proposed to serve as potential determinants of disease risk, prognosis or response to treatment, many markers only get evaluated in one or a small number of studies. A review in the June 1st edition of JAMA reports that the results of highly cited biomarker-disease associations that appear in major journals are often substantially overestimated, with effect sizes exceeding those found when the association is evaluated in larger studies.

• Roche, UCLA Announce Biomarker Research Collaboration

  Roche said last week that it will provide UCLA scientists with a range of genomics tools as part of a research collaboration to study stem cells and cancer, and for the development of new predictive biomarkers for future therapeutics and diagnostics for a host of diseases.

• Stemina Biomarker Discovery, Children’s Hospital of Orange County Sign Agreement to Study Autism

  Stemina Biomarker Discovery announced on Friday that it has signed an agreement with Children’s Hospital of Orange County (CHOC) to conduct a study of neural cells from autistic patients using Stemina’s proprietary biomarker discovery platform.

• Indiana CTSI, GVK Biosciences Partner to Provide National Access to Biomarkers Database

  The Indiana Clinical and Translational Sciences Institute (CTSI), a statewide collaboration of Indiana University, Purdue University and the University of Notre Dame, as well as public and private partnerships, which facilitates the translation of scientific discoveries in the lab into clinical trials and new patient treatments in Indiana and beyond, announced on Friday that they have partnered with GVK Biosciences. GVK Biosciences will provide researchers across the United States access to their clinical biomarker database.

• Biomarker Briefs: June 13, 2011

  Biomarker Briefs is an occasionally recurring series highlighting particularly interesting articles on biomarkers and/or personalized medicine. This edition includes articles on personalized medicine, a new online tool for analyzing personal genome data, a blood test for depression, and a kidney injury biomarker initiative.