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Archives for February 2013

Nanomix Initiates Clinical Testing of Point of Care IVD Cardiac Panel

Nanōmix Inc., (Nanōmix), a leading nanotechnology company focused on development of next generation point of care diagnostic tests to enable earlier and more accurate testing in hospital and pre-hospital settings, recently announced that it has initiated clinical testing in the U.S. to evaluate the Omega 3 Cardiac Panel.

Clinical Advantages of Critical Diagnostics’ Cardiac Biomarker ST2 Featured In YouTube Video

Critical Diagnostics, makers of the Presage® ST2 Assay, recently announced that a six-minute videotape by Antoni Bayes-Genis, MD PhD., head of Cardiology Service at Hospital Germans Trias i Pujol, in Barcelona Spain discussing results of a study just completed on the use of biomarkers over conventional clinical assessments for risk stratification of heart failure patients has been posted on YouTube for immediate viewing.

The study followed 876 heart failure patients with a mean age of 70.3 years for a period of 40 months. During this follow up period, 311 patients died. Researchers compared 11 clinical variables, including age, sex, ischemic etiology of heart failure, left ventricular ejection fraction, New York Heart Association functional class, diabetes, renal function, beta blocker treatment, ace inhibitor treatment, sodium and hemoglobin biomarkers, which are routinely used to stratify heart failure risk against three biomarkers: NT-proBNP from Roche (OTC: RHHBY), high-sensitivity troponin T and Critical Diagnostics’ ST2.

The results from this recent study highlights the enduring clinical utility of ST2 despite being combined with the established and widely accepted cardiac biomarkers, like NTpro BNP, in medical practice. “The best results were obtained for ST2 and high-sensitivity troponin T,” notes Dr. Bayes-Genis, the primary investigator of the study. “Whenever we added NT-proBNP to these other two biomarkers, net reclassification improvement was reduced.”

Check out the video below.

“We are seeing strong adoption of ST2 by leading cardiologists who understand many of the limitations of utilizing natriuretic peptide markers like BNP and NT-proBNP in their practice,” states David Geliebter, CEO of Critical Diagnostics. “Natriuretic peptide markers certainly have their role in diagnosing heart failure, but fall short in guiding treatment of diseased patients. In study after study, ST2 has consistently demonstrated improved accuracy of patient prognosis over natriuretic peptide markers alone.

“Two of the biggest criticisms we hear about natriuretic peptide markers are that their levels don’t change or change too slowly, so their value as a serial marker for guiding treatment is questionable and, furthermore, that results are often skewed by other influencers such as age, gender, body mass index, atrial fibrillation, history of heart failure, anemia and impaired renal failure. By comparison, ST2 levels change rapidly in response to changes in the patient’s condition—sometimes within hours—thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust care, such as titrating medication. Moreover, unlike natriuretic peptide markers, ST2 levels are not adversely affected by the above-mentioned confounding factors.”

“Heart failure has become a growing public epidemic, with increasing incidence and prevalence,” Dr. Bayes-Genis stresses. “As a result, there is a need to understand risk factors and risk stratifiers, to better identify the patients that are going to have a better or a worse outcome. We now have a new generation of biomarkers, high-sensitivity troponin T and ST2, which are easily measurable in our routine practice, which provide additional information to stratify the prognosis of patients with heart failure.”

Source: Critical Diagnostics

Agilent Technologies and Sera Prognostics Enter Strategic Partnership to Develop Proteomic Assays for Fetal and Maternal Health

Agilent Technologies Inc. (NYSE: A) and Sera Prognostics Inc., a women’s health company, recently announced a strategic partnership to develop proteomic assays for the early prediction of pregnancy complications.

Sera Prognostics is currently developing a novel test for the early prediction of preterm birth risk using advanced proteomic science. Agilent is a leading provider of a wide range of analytical instrumentation, including liquid chromatography, mass spectrometry and automation systems.

“By providing pivotal information to physicians, Sera’s preterm birth predictor is designed to address an unmet medical need for a reliable, early risk assessment that has the potential to help significantly improve the health of mothers and newborns, while materially reducing the costs of care,” said Gregory C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “Our partnership with Agilent provides Sera with access to advanced and innovative technologies designed to deliver on the promise of personalized medicine.”

“Agilent and Sera Prognostics share the vision of applying the power of advanced proteomic technologies to address meaningful medical challenges,” said Yvonne Linney, VP and general manager of Agilent’s Life Science Solutions Division. “Agilent instrumentation is at the forefront of driving high-throughput workflows for sample preparation and mass-spec analysis that is critical in the field of proteomics.”

As part of the partnership, Sera Prognostics purchased multiple Agilent 1290 Infinity ultra high-performance liquid chromatography systems, 6490 iFunnel triple quadrupole mass spectrometry systems and 1260 Infinity LC systems with ultraviolet detectors and is adapting Agilent’s automated sample-preparation technologies for production.

The partners will develop high-throughput workflows for sample preparation and mass-spectrometry analysis. To meet the demands of high-volume testing, Sera Prognostics expects to leverage Agilent’s novel automated sample-prep technology and other automation, including the AssayMAP Bravo and RapidFire fast liquid chromatography together with ultra-sensitive ion funnel triple quadrupole mass spectrometry.

Source: Agilent Technologies

New Article in PLOS Currents: Evidence on Genomic Tests Supports Use of Veracyte’s Afirma Gene Expression Classifier to Resolve Ambiguous Thyroid Nodule Biopsies

Veracyte, Inc. recently announced that a new review article published in PLOS Currents: Evidence on Genomic Testsconcludes that published studies and independent assessments and reviews of the Afirma Gene Expression Classifier support the test’s use to help resolve inconclusive results on thyroid nodule fine needle aspiration (FNA) samples, and thus help patients avoid unnecessary surgery as part of thyroid cancer diagnosis. The findings also reinforce recent guidelines from the National Comprehensive Cancer Network (NCCN) recommending that physicians consider using molecular testing in lieu of diagnostic surgery for patients with ambiguous thyroid nodule FNA results – provided the test’s performance is similar in accuracy to a benign diagnosis by cytopathology.

The authors determined that the clinical and analytical validation studies used to evaluate the Afirma Gene Expression Classifier were consistent with the stringent, Level 1 evidence criteria for study design and implementation standards established by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP), an initiative of the U.S. Centers for Disease Control’s Office of Public Health Genomics. The second and larger prospective clinical validation study involved 49 academic and community sites and found that when the genomic test reclassified indeterminate-cytology thyroid nodule FNA samples as benign – which it did more than half of the time – its accuracy was similar to a benign diagnosis using cytopathology. The new review article also evaluated the published literature regarding the test’s clinical utility, as well as technology assessments/guidelines by independent parties and professional groups, such as the national contractor that administers Medicare benefits and the NCCN.

“This new review paper helps to further establish the Afirma Gene Expression classifier as a valuable tool for helping thyroid nodule patients avoid unnecessary surgery, while also removing costs from the healthcare system,” said Bonnie Anderson, cofounder and chief executive officer of Veracyte. “It also supports the growing use of the test among community-based endocrinologists and leading academic institutions around the country.”

Thyroid cancer is the fastest-increasing cancer in the United States, with 60,220 new cases expected in 2013, according to the American Cancer Society. Approximately 450,000 thyroid nodule FNAs – a minimally invasive procedure to extract cells for examination under the microscope – are performed each year in the U.S. to rule out cancer. However, in 15% to 30% of cases, the results are inconclusive, and current protocols typically recommend thyroid surgery for final diagnosis. Following surgery, however, 70-80% of patients turn out to have benign nodules.

Study: Use of the Afirma® Gene Expression Classifier for Preoperative Identification of Benign Thyroid Nodules with Indeterminate Fine Needle Aspiration Cytopathology

Source: Veracyte

JPT Peptide Technologies and The Institute for Medical Immunology at the Charité in Berlin Announce Collaboration on Chronic Fatigue Syndrome

JPT Peptide Technologies GmbH (JPT), a wholly-owned subsidiary of BioNTech AG (Mainz, Germany), and The Institute for Medical Immunology at the Charité in Berlin recently announced a collaborative agreement on the development of serological peptide markers for the differential diagnosis of chronic fatigue syndrome (CFS).

“The previous success of our peptide microarray platform technology in identifying seromarkers in HIV, autoimmune diseases and cancer has led to this exciting opportunity to use our arrays to systematically explore other indications with high and unmet diagnostic and therapeutic need.”
CFS is a debilitating and complex disorder characterized by profound fatigue. Symptoms affect several body systems, frequently resulting in broadly reduced participation in daily activities. Definitive diagnosis of CFS is difficult and a diagnostic test is not available. Currently, diagnosis of CFS is achieved through the process of eliminating other diseases that have chronic fatigue as a symptom.

The goal of the partnership is to combine the long term expertise at the Charité Clinics for Immune Deficiencies in diagnosing CFS patients with JPT’s high-content peptide microarray approach to discover seromarkers that enable the development of a diagnostic test system.

Prof. Carmen Scheibenbogen, the project team head at the Charité stated: “Our previous and ongoing research at The Institute for Medical Immunology indicates a chronic activation of the immune system for a portion of our CFS patients. Preliminary results using JPT’s peptide microarray technology let us hope to find distinct serological markers that allow better diagnosis and treatment of CFS patients in the future.”

Holger Wenschuh, CEO at JPT adds, “The previous success of our peptide microarray platform technology in identifying seromarkers in HIV, autoimmune diseases and cancer has led to this exciting opportunity to use our arrays to systematically explore other indications with high and unmet diagnostic and therapeutic need.”

The collaboration project is supported in part by Pro FIT, a funding program of the Investitionsbank Berlin (IBB) and by the European Union (EFRE).

Source: Business Wire