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Nuclea Bio Acquires Oncogene Science, Extends Deal with Wilex

Just a few months after announcing several new partnerships and landing venture capital dollars, Nuclea Biotechnologies Inc. has snapped up Oncogene Science, an Cambridge, Mass.-based subsidiary of Wilex AG in Germany.

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.

Definiens and Advanced Cell Diagnostics Launch Software for Quantitative RNA In Situ Hybridization

Definiens AG, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD) of Hayward California, a leader in molecular pathology, announced recently the commercial launch of RNAscope® SpotStudio™, a custom-designed image analysis software application for ACD’s RNAscope®Assays to detect and quantify RNA biomarkers. By combining state-of-the-art image analysis and advanced in situ hybridization technologies, gene expression can be measured quantitatively at single cell resolution and interpreted by pathologists within context.

COPD Biomarker Qualification Consortium Making Strides with Plasma Fibrinogen as New Biomarker

The COPD Biomarkers Qualification Consortium (CBQC) recently announced at the European Respiratory Society Annual Congress that it has submitted a Qualification Package to the Food and Drug Administration (FDA) for plasma fibrinogen as a new drug development tool. The Qualification Package is the result of progressive discussions between the FDA’s Qualification Review Team and the CBQC. The CBQC looks forward to the results of FDA review while planning for a fall 2013 submission to the European Medicines Agency.

Dr. Ruth Tal-Singer, CBQC co-chair, vice president, Clinical Discovery, Respiratory Area Therapy Unit at GlaxoSmithKline, notes, “To the best of CBQC’s knowledge, fibrinogen is the first clinical biomarker achieving this milestone in the U.S. This is a major milestone for the CBQC, and it highlights the power of working together across multiple companies, academic centers and government organizations to achieve our common objective of improving the way we study novel medicines for patients who need them.”

To support the submission, the CBQC compiled a unique database of subjects from five individual studies, allowing integrated analyses to support two proposed uses as a prognostic biomarker to enrich clinical trial populations with Chronic Obstructive Pulmonary Disease (COPD) subjects at increased risk for all-cause mortality or COPD exacerbations.

A biomarker is a tool that can be used for early detection of a disease, selection of subjects for clinical trials or as an outcome for clinical trials. Fibrinogen, a protein that can be measured in the blood, is a promising biomarker which identifies a group representing 25 to 30 percent of all COPD patients (a COPD subtype).

Dr. Stephen Rennard, CBQC co-chair and Larson Professor of Medicine, University of Nebraska, adds, “COPD is extremely heterogeneous. This complicates development of new treatments, as individual COPD patients may respond differently. Fibrinogen has been submitted to the FDA as a tool that will help address this problem. Specifically, fibrinogen measurement can help identify COPD patients at risk for death or hospitalization, which can allow individuals to participate in studies of novel treatments designed to improve those outcomes.”

The CBQC, organized under the auspices of the COPD Foundation, is a public-private partnership among academic researchers, pharmaceutical companies and government parties and agencies.

John W. Walsh, president and co-founder, COPD Foundation, states, “The Consortium is providing a unique and productive opportunity to bring new drug development tools to the research community, with the ultimate goal of providing new treatments to patients who urgently need them.”

The CBQC Fibrinogen Working Group is composed of the following members:

  • Bruce Miller, industry co-chair, GlaxoSmithKline
  • Ruth Tal-Singer, GlaxoSmithKline
  • Mike Lowings, GlaxoSmithKline
  • Ubaldo Martin, AstraZeneca
  • Jeff Snyder, Boehringer-Ingelheim
  • Kay Tetzlaff, Boehringer-Ingelheim
  • Armin Furtwaengler, Boehringer-Ingelheim
  • Nicholas Locantore, GlaxoSmithKline
  • Nancy Leidy, Evidera
  • Amber Martin, Evidera
  • Jason Simeone, Evidera
  • David Mannino, academic co-chair, University of Kentucky
  • Stephen Rennard, University of Nebraska
  • David Lomas, University College London, U.K.
  • Jorgen Vestbo, University of Southern Denmark, University Hospital Manchester, U.K.
  • Graham Barr, Columbia University
  • Debora Merrill, COPD Foundation

Source: COPD Foundation

Thermo Fisher Scientific and Siemens Renew Partnership for Improved Detection of Sepsis Using B·R·A·H·M·S PCT Biomarker

Hospital laboratories outside the U.S. can benefit from a continued availability of the B·R·A·H·M·S PCT™ assay on ADVIA Centaur® systems, allowing them to diagnose sepsis early and safely.

Thermo Fisher and Siemens Healthcare Diagnostics renew their non-exclusive, long-term, royalty-bearing agreement for the use of Thermo Fisher’s Procalcitonin (B·R·A·H·M·S PCT™) technology, currently available as an automated immunoassay on the Siemens ADVIA Centaur® XP and CP systems in all countries outside the United States and China. The agreement extends a long-standing relationship between the companies.

ADVIA Centaur® B·R·A·H·M·S PCT™ immunoassay currently offers clinicians an integrated solution for accurately diagnosing sepsis and monitoring response to antibiotic therapy allowing for improved clinical decision making. The ADVIA Centaur® systems have a large global installed base in hospital clinical laboratories.

The PCT biomarker test is the gold standard for the early detection of sepsis in critically ill patients and is recommended to initiate, monitor and discontinue antibiotic treatment in the presence of relevant bacterial infections. Broader availability of PCT testing will lead to improved hospital management and care of patients with sepsis or at high risk of developing it.

“The continuation of our close collaboration with Siemens significantly increases the global reach of this critical biomarker, making it available to a broader patient population,” said Marc Tremblay, president of Thermo Fisher Scientific’s Clinical Diagnostics division. “The key for preventing sepsis is the early diagnosis of infections. Early diagnosis also reduces the health economic burden of sepsis therapy, a medical condition that is still very common today and accounts for hundreds of thousands of deaths each year. Therefore, PCT supports hospitals in optimizing their service levels and cost effectiveness in today’s challenging economic environment.”

The worldwide number of patients affected by sepsis is estimated to be 20 to 30 million annually and claims more lives than bowel and breast cancer combined. Despite advances in modern medicine, including antibiotics and vaccines, sepsis remains the primary cause of death from infection with hospital mortality rates between 30 to 60%1. Hospital costs to treat severe sepsis in the U.S. are estimated at $16 billion dollars annually. Much of this cost is attributed to misdiagnosis or delayed diagnosis, making rapid, more reliable detection a national, if not global, imperative. Research published in Critical Care Medicine showed that each hour of delay in therapy can decrease chances of patient survival by 7.6 percent.

Source: ThermoFisher Scientific