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Lifestyle, Age Linked to Diabetes-related Protein

Over the last decade researchers have amassed increasing evidence that relatively low levels of a protein called sex hormone binding globulin (SHBG) can indicate an elevated risk of type 2 diabetes and metabolic syndrome years in advance.

Independent Study: Health Diagnostic Laboratory, Inc. Services Lead to Cost Savings of 23% and Significantly Improved Health Outcomes After Two Years

Advanced cardiometabolic testing paired with follow-up health management from Health Diagnostic Laboratory, Inc. has resulted in a 23 percent decrease in a patient’s overall healthcare costs and an improved lipid profile in just two years, according to a new independent study published recently in Population Health Management.

Cancer Genetics, Inc. Receives Regulatory Approvals for MatBA®-DLBCL, a Proprietary Microarray Test for the Diagnosis, Prognosis, and Patient Risk Stratification of Non-Hodgkin Lymphoma

Cancer Genetics, Inc. (CGI), a leader in oncology-focused personalized medicine, today announced it has received CLIA and New York State approvals for clinical use of its proprietary mature B-cell neoplasm array or MatBA® (patent 13/475,034) for diffuse large B-cell lymphoma. MatBA®-DLBCL will assist clinicians in the diagnosis and prognosis of DLBCL.

DLBCL is the most common form of non-Hodgkin lymphoma (NHL), a diverse group of hematological malignancies. An estimated 190,000 people in the United State suffer from DLBCL, and up to 24,500 new U.S. cases diagnosed each year, which accounts for up to 40% of all NHL cases. Newly-diagnosed patients have a median age of 64 years, and disease progression and outcomes vary widely, due in part to the genomic characteristics of each individual patient’s cancer. This creates a strong clinical need for accurate and molecularly-informed prognostic testing both at the time of initial diagnosis and throughout ongoing disease monitoring efforts to ensure selection of the best treatment plan for an individual patient. However, current prognostic modalities rely primarily on clinical features.

CGI’s MatBA®-DLBCL microarray provides clinicians with information on genomic alterations in DLBCL, including regions of gain and loss that are associated with disease outcome.

A research collaboration between the Memorial Sloan-Kettering Cancer Center and CGI using 87 patient samples, as well as the analysis of two open datasets including 171 samples (GSE11318, Lenz et al.) and 51 high risk samples (E-MEXP-3463, Taskinen) and other published datasets showed that:

  • MatBA®-DLBCL has both diagnostic and prognostic value
  • MatBA®-DLBCL can assist in patient stratification for risk-adapted therapy when performed at diagnosis
  • MatBA®-DLBCL assesses the presence of single biomarkers as well as genome complexity as measures of overall survival following front-line immunochemotherapy

CGI believes that it is the only laboratory to have a CLIA and New York State approved microarray for the genomic assessment of DLBCL. The MatBA® -DLBCL Array CGH assay joins the DLBCL CompleteSM program offered by CGI, which includes a suite of esoteric tests used in the diagnosis, prognosis and clinical management of DLBCL patients. This newly-approved DLBCL test extends CGI’s ongoing commitment to developing new diagnostic and disease management tools for some of the most costly and critical unmet needs in oncology today. MatBA® -DLBCL joins MatBA® -CLL (chronic lymphocytic leukemia) and MatBA® -SLL (small lymphocytic leukemia) in CGI’s suite of CLIA- and New York State-approved proprietary microarrays for the clinical management of underserved hematological malignancies.

Source: Cancer Genetics

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

Gynecologic Oncology Publishes New Clinical Study Showing Positive Performance of OVA1, Vermillion’s Ovarian Cancer Test

Gynecologic Oncology, the prestigious medical journal of the Society for Gynecologic Oncology, has published the second prospective clinical study of OVA1® which demonstrated the positive performance of the multi-biomarker test in the triage of early-stage ovarian cancer.