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Rosetta Genomics Announces Acceptance for Publication of Kidney Cancer microRNA Diagnostic Manuscript by Molecular Oncology

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, recently announced that a manuscript regarding the development and validation of the Company’s microRNA-based diagnostic assay for the classification of renal cell tumors has been accepted for publication by Molecular Oncology. Yael Spector, a scientist from Rosetta Genomics, and Dr. Eddie Fridman , a pathologist and an expert in urological pathology from Sheba Medical Center in Tel-Hashomer, Israel, are the lead authors on the manuscript.

An unedited version of the manuscript is available online ahead of print publication of the final article at http://www.sciencedirect.com/science/article/pii/S157478911300046X.

The manuscript discusses the development and validation of the miRview® kidney assay, which differentiates between the four main types of primary kidney tumors: the three subtypes of renal cell carcinoma (RCC) namely clear cell, papillary and chromophobe RCC, and typically benign behaving oncocytoma. The assay was developed on a microarray platform using 181 training samples and validated on an independent set of 201 samples. The assay provided results for 92% of the validation samples, with 95% accuracy.

The topic of this manuscript will also be summarized in a poster to be presented on April 7 at the American Association for Cancer Research (AACR) Annual Meeting 2013 in Washington, D.C.

“There are an estimated 65,000 new cases of kidney cancer each year in the U.S. and more than 13,000 deaths. Distinguishing between the four main types of primary kidney tumors is critical in determining the optimal treatment regimen,” said Kenneth A.

Berlin , President and Chief Executive Officer of Rosetta Genomics. “Our miRview® kidney assay accurately classifies clear cell RCC, papillary RCC, chromophobe RCC and oncocytoma. We are delighted that this work has been accepted for publication in Molecular Oncology, an important industry trade journal.”

“The classification into subtypes of RCC has historically been less than definitive by histology, cytology and immunohistochemistry particularly in the growing context of fine needle aspirate (FNA) diagnostic specimens. The discrimination of the four subtypes can lead to the avoidance of aggressive surgical intervention in oncocytomas, and the others have differing biological behaviors that can be correlated with subtype. Importantly, newer therapeutic agents may show evidence of specificity of response by cell type. The expanded clarity of RCC diagnosis through the availability of this test will help lead to improved rationalization and optimization of new and emerging therapies, particularly in the community setting,” said Bob Wassman , M.D., Chief Medical Officer of Rosetta Genomics.

Source: PR Newswire

Trovagene Launches Urine-Based HPV Test

Trovagene, Inc. (NASDAQ: TROV), recently announced the commercial availability of its urine-based HPV-HR (high-risk) assay, a molecular human papillomavirus (HPV) test. The non-invasive test is designed to accurately identify the presence or absence of 15 known high-risk HPV strains using proprietary DNA sequences.

Approximately 20 million Americans carry HPV, with six million new cases occurring every year, according to the Centers for Disease Control and Prevention. By the age of 50, 80 percent of all women will have had exposure to HPV at some point in their lives. In 2012, the US Preventative Task Force recommended HPV DNA testing as a mandatory part of the cervical cancer screening guidelines to help diagnose a greater number of women and thereby reduce the risk of developing cervical cancer. Currently, less than 40 percent of women undergo HPV DNA testing in conjunction with a standard Pap smear or liquid cytology sample.

The Trovagene HPV-HR DNA test is a non-invasive option that may improve the adoption and acceptance rate of HPV testing. Carrier testing for HPV can help raise awareness and encourage use of preventative measures to reduce transmission of the virus. For women who wish to avoid repeated physical exams, but still need monitoring for their HPV status, a urine-based HPV-HR DNA test can facilitate more comprehensive patient monitoring.

“The launch of our urine-based HPV-HR DNA test represents an important milestone for Trovagene,” said Antonius Schuh, Ph.D., chief executive officer. “Non-invasive carrier testing may help to increase awareness of HPV status and could reduce the incidence of HPV-related cervical cancer and other cancers worldwide.”

The Trovagene HPV-HR test is available to patients through their healthcare providers. Physicians interested in utilizing the Trovagene assay should contact Client Services at 888-391-7992. For more information, please visit www.trovagene.com/HPV.

Source: Trovagene

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.

New Data Demonstrate Ability Of Oncohealth’s HPV E6/E7 Assays To Help Differentiate Cervical Disease From Clinically Insignificant HPV Infections

OncoHealth Corporation, a protein biomarker diagnostics company, recently announced three new studies demonstrating the effectiveness of assays using its proprietary HPV E6 and E7 biomarkers to distinguish clinically meaningful cervical disease from insignificant HPV infections. The findings were presented at the 28th International Papillomavirus Conference, held this week in San Juan, Puerto Rico. The studies, presented in two oral presentations and a poster, suggest that the company’s biomarkers and technology platform can be used to develop tests that may help clinicians better determine which women with abnormal cervical cancer screening results require additional testing or procedures.