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bioMerieux’s THxID-BRAF Test for Detection of 2 BRAF Mutations V600E and V600K in Late-Stage Metastatic Melanoma adopted by Clarient, a GE Healthcare Company

bioMerieux, Inc. and Clarient, a GE Healthcare Company recently announced that bioMerieux’s molecular diagnostic test THxID®-BRAF has been added to the service offerings provided by Clarient. Clarient will use THxID® BRAF in order to aid oncologists in selecting metastatic melanoma patients whose tumors carry the BRAF V600E mutation for possible treatment with GlaxoSmithKline’s (GSK) Tafinlar® (dabrafenib) as well as in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for possible treatment with Mekinist™ (trametinib).

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

Quest Diagnostics Launches New Molecular Test Panel for Enhanced Thyroid Cancer Detection

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic testing, information and services, today announced a new molecular test panel designed to help physicians determine if a thyroid gland is cancerous and requires surgical removal. The test is believed to be the most comprehensive panel clinically available to identify mutations associated with four gene markers indicated by the American Thyroid Association for the clinical management of indeterminate thyroid biopsies.

Rapid Technique Developed for Diagnosing Papillary Thyroid Cancer During Surgery

During surgical removal of thyroid tissue suspicious for cancer, fast, reliable, and cost-effective techniques are needed to analyze the resected tissue for biomarker — including BRAF V600E, a molecular biomarker for papillary thyroid cancer (PTC) — that can confirm the presence and type of cancer cells. Researchers have developed a new, rapid method for direct detection of the BRAF V600E gene in thyroid tissue without the need to purify DNA from tumor cells — high resolution melting analysis (HRM).

Asuragen to Present at Upcoming Association for Molecular Pathology 16th Annual Meeting

Asuragen, Inc., a leader in molecular diagnostic technologies, announced today that it will present at the upcoming Association for Molecular Pathology (AMP) 16th Annual Meeting, November 17-20, 2010 in San Jose, CA. Asuragen will have a significant scientific presence at the conference with a podium talk and ten posters highlighting Asuragen’s development efforts in the areas of oncology, genetic testing, microRNA and laboratory standards. Elizabeth Mambo, Ph.D. of Asuragen will deliver a platform presentation titled, “Serum miRNA Biomarkers for Lung Cancer Diagnostics” on Friday, November 19th. Early detection of lung cancer can play a significant role in the improvement of patient prognosis in lung cancer. Dr. Mambo will present data describing microRNA (miRNA) expression signatures to distinguish lung cancer from benign lung conditions.