United States

Profile: Rosetta Genomics Ltd (ROSG.O)

ROSG.O on Consolidated Issue listed on NASDAQ Capital Market

8 Dec 2016
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Rosetta Genomics Ltd., incorporated on March 9, 2000, is engaged in developing and commercializing new diagnostic tests based on various genomics markers, including deoxyribonucleic acid (DNA), micro ribonucleic acid (microRNA) and protein biomarkers and using various technologies, including, Quantitative polymerase chain reaction (qPCR), microarrays, Next Generation Sequencing (NGS) and Fluorescence In Situ Hybridization (FISH). The Company is marketing and selling over four diagnostic tests based on its microRNA technologies, which include RosettaGX Cancer Origin, mi-LUNG, mi-KIDNEY and RosettaGX Reveal. The Company's therapeutic pipeline consists of the projects, which include Rimonim Consortium and Magneton Project. The Company focuses on developing diagnostic assay, RosettaGX Reveal V2. It is also focusing on developing Bladder cancer risk stratification. The Company's PersonalizeDx is focused on the detection of genomic changes through FISH technology, which helps to detect cancer, measure the potential aggressiveness of the disease and identify patients to respond to targeted therapies.

RosettaGX Cancer Origin is the Company's second-generation microRNA-based diagnostic for the identification of the primary site of metastatic cancer, specifically metastatic cancer of unknown primary (CUP). RosettaGX Cancer Origin is able to identify over 49 tumor types that include carcinomas, soft tissue tumors, lymphoma and other malignancies with very high accuracy. The Company's RosettaGX Reveal is a microRNA-based assay for the diagnosis of indeterminate thyroid fine-needle aspirate (FNA) samples. The test utilizes routinely prepared FNA smears to diagnose a cytologically indeterminate thyroid nodule as benign or suspicious for malignancy by microRNA. The test also measures a microRNA biomarker for medullary carcinoma. FNA biopsy is the method for diagnosis of thyroid nodules.

The Company's mi-LUNG is a microRNA-based lung cancer classification test for cytology samples, mainly FNA samples, as well as pathology samples, such as small biopsies and resections. The test classifies primary lung cancers into Neuroendocrine vs. NSCLC and then further classifies NSCLC into squamous vs. non-squamous and Neuroendocrine into Small Cell Lung Cancer (SCLC) vs. carcinoid. The microRNA-based assay that it has developed is performed by measuring microRNA biomarkers in a sample from the tumor, where the sample can be either a cytology sample or a pathology sample. The assay measures the expression of approximately 10 microRNAs and using that expression accurately identifies the lung cancer subtype.

The Company's mi-KIDNEY test was designed to classify primary kidney tumors into one of the four most common types: the malignant renal cell carcinomas clear cell (conventional), papillary and chromophobe, as well as the benign oncocytoma. The histological subtypes vary in the clinical course and the prognosis, and different clinical strategies have been developed for the management. The microRNA-based assay that it has developed is performed by measuring microRNA biomarkers in a sample from the tumor. The assay uses the expression of over 25 microRNAs to identify the kidney tumor subtype.

The Company's RosettaGX Reveal V2 is focused on developing a second version of RosettaGX Reveal, a microRNA-based assay for the differential diagnosis of indeterminate thyroid FNAs that utilizes routinely prepared FNA smears. The second version combines RosettaGx Reveal's microRNA biomarkers with a panel of DNA-based biomarkers providing prognostic information. The Company's Bladder cancer risk stratification focuses on discovering tissue-based microRNA biomarkers for the purpose of developing a new assay for the risk stratification of patients with non-muscle-invasive bladder cancer.

The Company's PersonalizeDx is a commercial laboratory that performs testing services on three primary platforms: FISH, PCR and IHC. FISH and PCR are considered molecular tests that query specific chromosomes regions and genes in order to provide diagnostic, prognostic and predictive information to clients in order to assist with patient treatment decisions. Its UroVysion is a urine-based FISH assay intended for use in conjunction with and not with standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer. PersonalizeDx provides a tech only service option for UroVysion that allows Pathologists throughout the United States to partner with the lab through its virtual portal.

The Company's ERG and PTEN are FISH-based prognostic tests in prostate cancer that help urologists with the important decision point of whether or not to initiate surgery with the lower risk prostate cancer patients. ERG and PTEN have both been proven to be biomarkers in the progression of prostate cancer, and abnormal results specific to these genes may indicate the need for more aggressive treatment. ERG and PTEN testing is performed on the same tumor tissue that is taken from the patient's initial core needle biopsy procedure. PersonalizeDx also offers a tech only, virtual service for ERG and PTEN testing. Its ALK and ROS1 are FISH-based predictive tests indicated for patients that are diagnosed with late stage lung cancer. Patients that test positive for either ALK or ROS1 rearrangements are considered candidates for anaplastic lymphoma kinase (ALK)-inhibitor therapy, such as XALKORI (crizotinib). It also offers PCR Gene Mutation Analysis.

The Company competes with Cancer Genetics, Inc., Biotheranostics, Inc., Foundation Medicine, Veracyte, Inc., Alnylam Pharmaceuticals, Inc., Asuragen Inc., HTG Molecular Diagnostics Inc., Interpace Diagnostics, Exiqon A/S, Life Technologies Corporation, Isis Pharmaceuticals, Mirna Therapeutics, Merck & Co., Inc., Santaris Pharma A/S, Regulus Therapeutics, NeoGenomics Inc., Miraca, Bostwick and Healthtronics.

Company Address

Rosetta Genomics Ltd

10 Plaut Street, Science Park, P
REHOVOT     7670609
P: +9727.32220700
F: +9727.32220701

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