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Sanofi Announces Upcoming Launch of MyStar Extra, the First Self-Monitoring Blood Glucose Meter With Estimated A1c

At the annual meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain, Sanofi (EURONEXT : SAN and NYSE : SNY) recently presented the innovative blood glucose meter MyStar Extra®, the first self-monitoring device that provides robust estimates of the A1c value, a key indicator for long-term glucose control.[3],[4] The hemoglobin A1C (HbA1C) assay has become the cornerstone for the assessment of diabetes control and A1c test results are widely used to guide treatment decisions.[5],[6] Especially convenient for people starting on insulin or using insulin, MyStar Extra® is a supportive meter, designed to help people with diabetes be engaged in their insulin management and treatment plan.[7],[8],[9]

NextBio Announces Translational Medicine Partnership with Sanofi

NextBio recently announced a multi-year collaboration with Sanofi (NYSE:SNY) aimed at using NextBio Clinical to incorporate patient omics and clinical data into Sanofi’s drug research and development, as part of Sanofi’s Translational Medicine for Patients (TM4P) program.

Definiens Establishes Advisory Board

Definiens, the global leader of image and data analysis solutions for quantitative digital pathology, recently announced it has appointed an Advisory Board comprising renowned industry experts and visionaries in digital pathology. As part of its market expansion strategy, Definiens established the new Board to provide independent advice on trends and opportunities in tissue diagnostics and clinical digital pathology.

Members of the Advisory Board include:

  • Ron A. Andrews, President, Medical Sciences, Life Technologies and former CEO of Clarient and CEO of GE Molecular Diagnostics
  • Prof. Uwe Bicker, Dean of the Medical Faculty Mannheim, University of Heidelberg and a member of the board of directors of Sanofi SA
  • Prof. Manfred Dietel, Director, Institute of Pathology, Charité Berlin and chairman of the German Society for Pathology
  • Eric F. Glassy, M.D., Medical Director, Pathology, Inc.and chairman of the Digital Pathology Working Group of the College of American Pathologists
  • Prof. Gerd Binnig, Founder and CTO, Definiens (Moderator)

“Definiens is working to advance personalized medicine by contributing to the development of next generation diagnostics, and bringing those novel diagnostics into clinical practice. Our innovations have the potential to transform daily clinical practice for the benefit of both patients and pathologists, particularly in oncology,” said Thomas Heydler, CEO of Definiens. “We will greatly benefit from the wealth of experience of the Advisory Board members while expanding our business into tissue diagnostics and clinical digital pathology.”

As part of its goal to guide Definiens during the company’s expansion, the Advisory Board will discuss trends in digital pathology and highlight opportunities for image and data analysis to revolutionize clinical practice in pathology. Specific topics of discussion will include pathology workflow, tissue diagnostic test development, personalized medicine and next-generation cancer treatment, as well as future technology and market requirements. Definiens founder and Nobel laureate, Professor Gerd Binnig, will catalyze the discussions.

“With the novel opportunities enabled by digital pathology, progress in diagnosing and treating cancer will be accelerated. The visionary power and expertise brought together in the Definiens Advisory Board will be invaluable on our path towards bringing advanced image analysis to clinical pathology,” said Prof. Gerd Binnig, Founder and CTO of Definiens.

Source: Definiens

Veracyte Announces Results of Study Assessing Use of BRAF Mutation Testing With Its Afirma® Gene Expression Classifier

Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced new study findings showing that when BRAF V600E mutation testing was conducted on ambiguous thyroid nodule samples that were subsequently classified as benign by the company’s Afirma Gene Expression Classifier, no BRAF-positive cases – that would suggest cancer – were found. The study appears online in the Journal of Clinical Endocrinology & Metabolism.

“Multicenter, prospective studies have previously established the high accuracy of the Afirma Gene Expression Classifier in identifying patients with inconclusive thyroid nodule biopsies whose nodules are actually benign and can thus safely avoid unnecessary surgery,” said Giulia C. Kennedy, Ph.D., chief scientific officer of Veracyte, and an author of the new study. “Our findings showed that testing for BRAF – a gene mutation linked to some thyroid cancers – did not identify any cancer cases among those deemed benign by the Afirma test. Additionally, BRAF mutations were found in only a small portion (30%) of the samples that turned out to be malignant and were classified by the Afirma test as suspicious.”

BRAF mutation testing was conducted on 208 thyroid nodule FNA samples that were indeterminate – not clearly benign or malignant following cytopathology (microscope-based) review. These samples had subsequently been tested with the Afirma Gene Expression Classifier as part of a prospective, double-blinded, multicenter (49-site) study. BRAF mutations were found in 10% of indeterminate cases overall, and in just 2.1% and 1.4%, respectively, of the two most common subcategories of indeterminate thyroid nodule biopsies.

The Afirma Gene Expression Classifier measures the expression of 142 genes to reclassify indeterminate thyroid FNA samples as either benign or suspicious for cancer. An additional 25 supplemental genes are used to improve classification of rare cancer subtypes. The Afirma test is the only molecular test clinically validated in prospective, multicenter, double-blinded trials to meet the criteria of National Comprehensive Cancer Network (NCCN) guidelines for safely monitoring nodules in lieu of diagnostic surgery. The test is offered as part of Veracyte’s comprehensive Afirma Thyroid FNA Analysis, which combines specialized cytopathology assessment for initial review of thyroid nodule FNAs, with the gene expression test used to clarify inconclusive results. The test is available throughout the U.S. through a global co-promotion partnership with Genzyme, a Sanofi company.

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, 15% to 30% of FNA biopsy results are inconclusive, and most physicians recommend thyroid surgery for final diagnosis. Following surgery, however, 70-80% of patients’ nodules are diagnosed as benign. These surgeries are invasive, expensive, and typically result in lifelong thyroid hormone replacement therapy for the patient.

Study: Does Addition of BRAF V600E Mutation Testing Modify Sensitivity or Specificity of the Afirma Gene Expression Classifier in Cytologically Indeterminate Thyroid Nodules?

Source: Veracyte

Veracyte Announces UnitedHealthcare Coverage Policy For the Afirma® Gene Expression Classifier

Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced that UnitedHealthcare, one of the nation’s largest private health insurers, has issued a positive medical coverage policy for the Afirma® Gene Expression Classifier for use in assessing thyroid nodule fine needle aspirate (FNA) biopsies that are indeterminate – not clearly benign or malignant following traditional cytology review. The new medical coverage policy will apply to the insurer’s nearly 27 million commercial members, effective April 1, 2013. Veracyte’s genomic test is already covered for approximately 40 million Medicare patients nationwide.