Showing posts with label ROSG. Show all posts
Showing posts with label ROSG. Show all posts

Tuesday, June 26, 2012

Rosetta Genomics (Nasdaq:RPSG) Announces NY Approval for miRview(R) lung

Rosetta Genomics (Nasdaq:RPSG) Announces NY Approval for miRview(R) lungAtlanta, GA 6/26/12 (StreetBeat) -- Rosetta Genomics (Nasdaq:ROSG), a leading developer and provider of microRNA-based molecular diagnostic assays, announced that the New York State Department of Health ("NYSDOH") has given the Company conditional approval for its miRview® lung assay for testing on patient samples from the State. New York is the only U.S. state that requires an independent regulatory review process for laboratory-developed tests. With this approval, Rosetta Genomics can offer miRview® lung in all 50 U.S. states. In making the assay available pending final approval, the NYSDOH requires the Company to provide any additional information they request within 60 business days. miRview® lung is the Company's proprietary microRNA-based assay that accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells.

"Lung cancer is the second most common cancer and is the primary cause of cancer-related death in both men and women in the U.S. With the introduction of targeted lung cancer therapies, such as Avastin® and Alimta®, and with other targeted drugs entering the clinical arena, accurate classification and subtyping of lung cancer is becoming increasingly important to better assess differential side effects and efficacy profiles and to enhance treatment strategies," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "With a sensitivity of 95% for very small sample sizes, such as cytological samples, we believe this assay can be a useful tool for pathologists and we are very pleased to have approval to market this important cancer diagnostic for the benefit of physicians and patients in New York."

About miRview® Products
miRview® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview® mets and miRview® mets² accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview® squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview® kidney accurately classifies the four most common kidney tumors: Clear Cell Renal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC and Oncocytoma. miRview® tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview® mets and miRview® mets² test, 60,000 from miRview® squamous, 60,000 from miRview® meso, 54,000 from miRview® kidney and more than 1 million patients worldwide from miRview® lung. The Company's tests are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visitwww.mirviewdx.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.

About Rosetta Genomics
Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, the Company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. The Company's miRview® product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visitwww.rosettagenomics.com.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Tuesday, June 19, 2012

Biotech Industry Showing Investors Impressive Gains in 2012

Biotech Industry Showing Investors Impressive Gains in 2012Northern, WI 6/19/12 (StreetBeat) -- Despite the recent economic turmoil in Europe, the Biotech Industry has been home to some of the strongest performers in the market in 2012. The SPDR S&P Biotech ETF (XBI) and the First Trust NYSE Arca Biotech Index ETF (FBT) year-to-date are up 26 percent and 32 percent, respectively. As the world continues to face evolving health challenges the discoveries of new therapeutics and vaccines are critical. Five Star Equities examines the outlook for companies in the Biotech Industry and provides equity research on Celldex Therapeutics, Inc. (Nasdaq:CLDX) and Rosetta Genomics Ltd. (Nasdaq:ROSG).

Expiring patents have been a major dilemma for pharmaceutical companies. New products that are being introduced are not expected to generate the same level of revenues of the products that have lost patent protection. The Obama administration is currently analyzing a proposal in which the exclusivity period for biologics would be cut down by 5 years. Mergers & Acquisitions activity is expected to pick up in 2012 as companies to look to make up for loss revenues. M&A allow companies to acquire products that are already proven in the market place without the hassle and costs associated with research and development.

"Many of the pharmaceutical companies started producing everything in-house out of their own R&D organizations and over time they've failed to produce enough that way. So the industry is now coalescing around a 50-50 model of half on your own and half bought in. There are some things we'll do for ourselves but we need to be constantly on the lookout for new technologies," said Angus Russell, Chief Executive of Shire PLC.

Celldex Therapeutics has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform. Shares of the company are up nearly 67 percent year-to-date. As of March 31, 2012, Celldex reported cash, cash equivalents and marketable securities of $92.1 million, which the Company believes will be sufficient to meet estimated working capital requirements and fund planned program development into 2014.

Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics. The Company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Friday, May 25, 2012

Friday’s top gaining and declining stocks

Friday’s top gaining and declining stocksOrlando, FL 5/25/12 (StreetBeat) – Here are some of the biggest gaining and declining stocks this Friday:

Gainers

Shares of Frontline Ltd. (NYSE: FRO +10.64%) rose 8.3%. The firm posted better than expected results early Friday and gave an optimistic outlook for the future.

Infoblox Inc. (NYSE: BLOX +2.26%) shares rose 7.8% on Friday.The firm recently reported fiscal third-quarter results and said it expects a gross margin of 76% in its fourth quarter.

Decliners

Rosetta Genomics Ltd. (Nasdaq: ROSG -6.16%) fell 12%. The company said early Friday that it is selling 570,755 shares of stock to investors at a 29% discount. The firm said it’s raising the cash to help fund operations.

Verifone Systems Inc. (NYSE: PAY -11.53%) shares shed 8.3% on Friday. Late Thursday the company said that its fiscal second-quarter profit fell 43% and said that it expected earnings in the future a bit below Wall Street analyst expectations.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Wednesday, May 16, 2012

Rosetta Genomics (Nasdaq: ROSG) Achieves Major Commercial Milestone

Rosetta Genomics (Nasdaq: ROSG) Achieves Major Commercial MilestoneOrlando, FL 5/16/12 (StreetBeat) -- Rosetta Genomics Ltd. (Nasdaq: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, today announced that Novitas, the designated Medicare Administrative Contractor for the Company's miRview® mets² assay, has informed Rosetta that it plans to cover this assay for all Medicare beneficiaries. MiRview® mets² accurately identifies the primary tumor of origin in primary and metastatic cancer including Cancer of Unknown or Uncertain Primary ("CUP").

"This is a major commercial achievement for Rosetta Genomics asMedicare coverage is a critical step toward widespread commercial adoption and payment for our lead diagnostic assay, miRview® mets², and enables access to this clinically valuable test to Medicare patients. This decision is important not only because Medicare is the largest U.S. payor, covering a large percentage of the patients for whom miRview® mets² has been ordered historically and would be expected to be ordered in the future, but also because private payors often look to Medicare's decisions when setting their own reimbursement policies," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We are particularly pleased with how rapidly we obtained Medicare coverage, as we launched our direct selling effort in the U.S. just one year ago.

"The decision by Novitas to cover the miRview® mets² assay reflects the clinical importance of determining the tumor origin in hard-to-diagnose metastatic cancers and CUP. This is particularly important as new, targeted cancer treatments are developed for site-specific cancers. We believe that the miRview® mets² assay is an important tool that can improve the ability of physicians to accurately diagnose CUP in order to optimize treatment plans," added Mr. Berlin.

The policy will cover the 45 million Medicare beneficiaries and will enable Rosetta to provide the miRview® mets2 assay for Medicare beneficiaries throughout the U.S. at no cost to the patient, thereby eliminating an adoption barrier for the physician ordering the test and for the patient. Novitas' decision is based on the extensive body of clinical data published in peer-reviewed journals from clinical studies conducted internally as well as at leading institutions. Once the Novitas decision is finalized with respect to reimbursement level, we will focus our efforts on obtaining appropriate coverage and reimbursement from commercial payors.

"This coverage decision will allow all appropriate Medicare patients access to the miRview® mets² assay and further recognizes the value that our assays are delivering to physicians, payors and patients. We look forward to continuing our dialogue with Novitas, and to their final decision on reimbursement level within the coming weeks," concluded Mr. Berlin.

About miRview® Products
miRview® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview® mets and miRview® mets² accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview® squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview® kidney accurately classifies the four most common kidney tumors: Clear Cell Renal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC and Oncocytoma. miRview® tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview® mets and miRview® mets² test, 60,000 from miRview® squamous, 60,000 from miRview® meso, 54,000 from miRview® kidney and more than 1 million patients worldwide from miRview® lung. The Company's tests are offered directly by Rosetta Genomics in the U.S., and through distributors around the globe. For more information, please visitwww.mirviewdx.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.

About Rosetta Genomics
Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, the Company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. The Company's miRview® product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visitwww.rosettagenomics.com.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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