Quantcast

Industry news that matters to you.  Learn more

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

Nodality, Inc. Reports Promising Rheumatoid Arthritis Study Results to Predict Patient Treatment Response to TNF Inhibitors

Nodality, Inc., an innovative biotechnology company advancing discovery, development and use of transformative therapies by revealing functional systems biology, recently announced results of the Company’s comprehensive research study to identify cell markers (biomarkers) of disease activity and treatment success in rheumatoid arthritis (RA) patients. The study findings demonstrated that Nodality’s SCNP technology, which measures functional pathways at the single cell level, can be used to identify biomarkers of responsiveness to treatment with tumor necrosis factor inhibitors (TNFIs). RA affects an estimated two million Americans, and TNFIs constitute the most commonly prescribed therapy. Approximately half of patients respond to treatments such as TNFIs, leaving a substantial unmet need to identify which patients are more likely to respond to current therapies. Optimizing use of currently available therapies could potentially delay tissue damage and progression of disease.

SCNP provides the core technology foundation for Nodality’s programs dedicated to improving clinical medicine by increasing the efficiency of therapeutic R&D programs, enhancing life cycle management for commercialized drugs, and introducing new predictive diagnostics. The study results were featured in an oral presentation titled, Comparison of functional immune signaling profiles in peripheral blood mononuclear cells (PBMC) from rheumatoid arthritis (RA) patients versus healthy donors (HD) using Single Cell Network Profiling (SCNP) (Abstract W7.02.04), at the 15th International Congress of Immunology (ICI) in Milan, Italy, taking place August 22 to 27, 2013. The findings were presented by S. Louis Bridges, Jr., M.D., Ph.D., Marguerite Jones Harbert-Gene V. Ball, MD Professor of Medicine, Director, Division of Clinical Immunology and Rheumatology, University of Alabama School of Medicine.

“Nodality’s research program demonstrates the great promise and potential in gaining a better understanding of disease biology and applying this to the development of prognostic and predictive biomarkers for autoimmune diseases such as RA,” commented Alessandra Cesano, M.D., Ph.D., Chief Medical Officer of Nodality. “I look forward to the final results of this program, one of the most comprehensive of its kind. Our technology, based on immune-biology, can predict which RA patients will respond to specific therapies and reveal the mechanisms of drug resistance, thus informing alternative therapeutic strategies.”

The Nodality research program compares healthy and diseased peripheral blood cells at the single cell level, studying samples obtained through the national Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository (TETRAD). Nodality anticipates completing its research program and announcing the key findings later this year.

Laura Brege, Nodality’s President and Chief Executive Officer, stated, “ICI has provided an important opportunity to showcase one of our key programs in immunology, further validating our broadly enabling SCNP platform. This platform has led to major collaborations in immunology addressing significant unmet needs among patients, as well as new predictive diagnostic modalities in blood cancers. Ultimately, Nodality’s goal is to accelerate and make more efficient the development of new therapeutic agents for serious diseases affecting large patient populations within immunology and oncology, two areas of continuing significant unmet clinical need.”

Additional program results were featured in a second oral presentation at the ICI Congress in a presentation titled, Functional proteomic interrogation of immune cell crosstalk and the effects of cytokine-targeted inhibitors using Single Cell Network Profiling (SCNP) (Abstract W7.02.03).

Source: Nodality, Inc

bioTheranostics Receives Positive Coverage Decision and In-Network Provider Status from Tufts Health Plan for Its CancerTYPE ID Molecular Test for Metastatic Cancer

bioTheranostics, a leading provider of molecular diagnostic solutions for cancer, has received a positive coverage decision and in-network provider status from Tufts Health Plan for its CancerTYPE ID® molecular cancer classifier. Massachusetts-based Tufts Health Plan is one of the nation’s most highly rated health plans serving more than 1 million members.

CancerTYPE ID is a molecular cancer classifier that predicts tumor type in patients with metastatic cancers—among the most difficult to diagnose and treat cancers. Numerous clinical trials and economic analyses have been completed that reinforce the clinical validity and utility, prognostic performance, and cost-effectiveness of the test.

Richard Ding, president and CEO of bioTheranostics, said, “We are pleased that Tufts Health Plan is following Medicare and recognizing the value of the CancerTYPE ID test in the management of metastatic cancer. With metastatic cancer, achieving diagnostic certainty is critical to optimize site-directed therapies that reduce costs and avoid ineffective therapies for both patients and payors. This announcement is part of our efforts to work with payors across the country to make this important diagnostic test available to clinicians and cancer patients, helping to support personalized medicine with the goal of improving outcomes.”

CancerTYPE ID is becoming a standard tool in metastatic cancer management. More than 400,000 patients present with metastatic cancers in the United States each year. An accurate diagnosis of the site of origin is the first step toward personalized medicine, allowing clinicians managing these patients to treat them most effectively using site-specific therapy.

Source: Business Wire

Key Assay Development at HUPO

Proteome Sciences presented novel data and key assay developments at the HUPO 12th Annual World Congress in Japan covering Tau in Alzheimer’s disease, SysQuant® in pancreatic cancer and a missing isoform in sugar structures of clusterin, a plasma protein biomarker for Alzheimer’s in brain atrophy.

pTau

The new Tau phosphorylation assay (pTau SRM) demonstrated powerful sensitivity and reproductivity measuring Tau phosphorylation on human and mouse models of Alzheimer’s disease from a much smaller sample amount.

In a different application the pTau SRM was successfully used to determine the effect of Tau kinase inhibitors PS110 and PS278-05 on CK1d on the Tau protein in a mouse model of Alzheimer’s. The results confirmed that Tau phosphorylation was reduced by the two compounds but not affected by the control substance.

SysQuant®

Over 5,000 different phosphorylation sites were quantified in tumour and healthy tissue in pancreas cancer with SysQuant®. In addition to major alterations in proteins related to cell morphology and motility, individual patterns of pathway activation were able to accurately predict the likelihood of tumour recurrence and to provide a truly personalised treatment regime.

Glycopreotomics

Novel data was presented that showed diagnostic changes in sugar structures attached to clusterin, a plasma marker for Alzheimer’s in brain atrophy. This revealed a unique isoform that lacked a specific branching pattern in patients with high levels of brain atrophy.

Commenting from Yokohama, Dr. Ian Pike, Chief Operating Officer, said: 

“We were delighted to be invited to the 12th HUPO congress to show results from the powerful biomarker services platform that we have developed from our TMT® mass tags for customers where we are at the forefront in proteomics. New assays for pTau and clusterin glycoprotein provide important additions to the range of assays and services that we offer our customers in Alzheimer’s The added power delivered by SysQuant® identifies thousands of phosphorylation sites across key signalling pathways that give clinicians the ability for the first time to provide real time patient management, in this case in pancreas cancer. These are exciting developments from proteomics that are fundamentally changing how clinicians identify and manage disease.”

Source: Proteome Sciences

bioTheranostics is Now an In-Network Provider with Highmark Health Services for Its CancerTYPE ID Molecular Test for Metastatic Cancer

bioTheranostics, a leading provider of molecular diagnostic solutions for cancer, is now an in-network provider with Highmark Health Services, and the company’s CancerTYPE ID® molecular cancer classification test may be eligible for Highmark members based on the member’s individual benefits. Pittsburgh-based Highmark is one of the largest health insurers in the United States and the fourth-largest Blue Cross and Blue Shield-affiliated company, operating health plans that serve 5.3 million members.

CancerTYPE ID, an industry-leading molecular cancer classifier based on the expression of 92 genes, predicts tumor type in patients with metastatic cancers—among the most difficult to diagnose and treat cancers.

Richard Ding, president and CEO of bioTheranostics, said, “We are delighted that Highmark is recognizing the value of the CancerTYPE ID test, which is becoming a standard tool of metastatic cancer management. We have built a strong foundation of evidence supporting CancerTYPE ID—from clinical validity to clinical utility and health outcomes. We are working diligently with the payor community to make this high-value diagnostic test available to patients with metastatic cancer and the clinicians caring for them.”

Ding said that in managing metastatic cancer, achieving diagnostic certainty is critical to optimize site-directed therapies that reduce costs and avoid ineffective therapies for both payors and patients. More than 400,000 patients present with metastatic cancers in the United States each year. An accurate diagnosis is the first step toward personalized medicine, allowing clinicians managing these patients to treat them most effectively using site-specific therapy.

Source: BusinessWire