The overall ratings of 10 insurance stocks are down on Portfolio Grader this week. Each of these rates a “D” (“sell”) or “F” overall (“strong sell”).
Best Industrial Conglomerate Companies To Invest In Right Now: Senesco Technologies Inc (SNTI)
Senesco Technologies, Inc., incorporated on September 30. 1999, is engaged in utilize its eukaryotic translation initiation Factor 5A, or Factor 5A, and deoxyhypusine synthase (DHS), and related technologies for human therapeutic applications to develop approaches to treat cancer and inflammatory diseases. In agricultural applications, the Company has licensed applications of the Factor 5A, DHS and Lipase platforms to develop the productivity of fruits, flowers, vegetables, agronomic and biofuel feedstock crops through the control of cell death and growth in plants.
Human Therapeutic Applications
The Company has developed a therapeutic candidate, SNS01-T, an improved formulation of SNS01, for the potential treatment of multiple myeloma and non-Hodgkin B-cell lymplomas. SNS01-T utilizes the Company's Factor 5A technology and consists of two components, which include a DNA plasmid (pDNA), expressing human eIF5A containing a lysine to arginine substitution at amino acid position 50, (eIF5AK50R), and a small inhibitory RNA (siRNA). These two components are combined in a fixed ratio with a polymer, polyethyleneimine (PEI), which enables self-assembly of the DNA and RNA into nanoparticles with demonstrated enhanced delivery to tissues and protection from degradation in the blood stream. The Company has also demonstrated that the combination of lenalidomide and SNS 01-T performs better than either treatment alone in mouses xenograft models of human mantle cell lymphoma. The Company's human therapeutic research program, which consists of pre-clinical in-vitro and in-vivo experiments designed to assess the role and mode of action of Factor 5A in human diseases and a phase 1a/2b clinical trial.
The Company competes with Celgene, Inc., Takeda/Millennium, ONYX Pharmaceuticals, Inc., Amgen Inc., Janssen Biotech, Inc., Novartis AG, and Pharmacyclics, Inc.
Agricultural Applications
The Company's agricultural research focuses on the discovery and develo! pment of certain gene technologies, which are designed to confer positive traits on fruits, flowers, vegetables, forestry species and agronomic crops. The Company's research and development initiatives for agriculture include develop and implement the DHS and Factor 5A gene technology in banana, canola, cotton, turfgrass, rice, alfalfa, corn, soybean and trees; and test the resultant crops for new beneficial traits such as increased yield, increased tolerance to environmental stress, disease resistance and more efficient use of fertilizer.
The Company competes with Mendel Biotechnology, Renessen LLC, Exelixis Plant Sciences, Inc., and Syngenta International AG.
Advisors' Opinion:- [By CRWE]
Today, SNTI has shed (-2.44%) down -0.0010 at $.0400 with�723,673 shares in play thus far (ref. google finance Delayed: 2:58PM EDT October 7, 2013).
Senesco Technologies, Inc. previously reported it has entered into a securities purchase agreement with certain investors to raise $1.725 million in gross proceeds through the sale of 69,000,000 shares of its common stock. The common stock was priced at $0.025 per share.
The offering is expected to close on or about October 2, 2013, subject to customary closing conditions. The net proceeds of the financing will be used primarily for working capital, research and development and general corporate purposes.
- [By Peter Graham]
At the end of last week, small cap stocks Senesco Technologies, Inc (OTCBB: SNTI), VolitionRX Ltd (OTCMKTS: VNRX) and Micromem Technologies Inc (OTCBB: MMTIF) were all trending upwards ��ending up 13.65%, 8.73% and 7.61%, respectively, on Friday. However, it�� a new trading week with the last two trading days for the year. So what direction will these three small caps head in for the end of this year and into next year? Here is a quick look to help you decide on a trading or investment strategy:
Top 10 Biotech Stocks To Invest In Right Now: IsoRay Inc (ISR)
IsoRay, Inc. (IsoRay), incorporated on June 15, 2004, develops, manufactures and sells isotope-based medical products and devices for the treatment of cancer and other malignant diseases. IsoRay International LLC (International) is a wholly owned subsidiary of the Company. IsoRay obtained clearance from the Food and Drug Association (FDA) for treatment for all solid tumor applications using Cesium-131. Such applications include prostate cancer; ocular melanoma; head, neck and lung tumors; breast cancer; liver cancer; brain cancer; colorectal cancer; gynecological cancer; esophageal cancer, and pancreatic cancer. The seed may be used in surface, interstitial and intracavity applications for tumors with known radio sensitivity. The Company has an existing distribution agreement with UralDial LLC (UralDial) that allows UralDial to distribute Proxcelan Cs-131 brachytherapy seeds in Russia. The Company, through UralDial, has regulatory approval to sell Cs-131 seeds in Russia.
IsoRay markets the Proxcelan Cesium-131 brachytherapy seed for the treatment of prostate cancer; lung cancer; ocular melanoma; head and neck cancers; colorectal cancer, brain cancer; and gynecological cancer. The Company focuses to market Cesium-131 for the treatment of other malignant disease, such as breast cancer, in the near future through the use of existing technologies that have received FDA-clearance. Cesium-131 is a radioactive isotope that can be produced by the neutron bombardment of Barium-130 (Ba-130). When placed into a nuclear reactor and exposed to a flux of neutrons, Ba-130 becomes Ba-131, the radioactive material that is the parent isotope of Cesium-131. The radioactive isotope Cesium-131 is normally produced by placing a quantity of stable non-radioactive barium (ideally barium enriched in isotope Ba-130) into the neutron flux of a nuclear reactor. The irradiation process converts a small fraction of this material into a radioactive form of barium (Ba-131). The Ba-131 decays by electron capture to the ! radioactive isotope of interest (Cesium-131).
As of June 30, 2011, IsoRay had agreements with several independent radiopharmacies to assay, preload, and sterilize loose seeds. During the fiscal year ended June 30, 2011, the Company loaded approximately 90% of Mick cartridges in the Company's own facility, which accounted for approximately 61% of seeds sold. Approximately 33% of seeds sold are strand configurations, including strands preloaded in needles and the remaining 6% of seeds are sold as loose seeds.
Advisors' Opinion:- [By James E. Brumley]
I hate to be the one to say I told you so, but, I told you so. Back on February 26th I suggested IsoRay, Inc. (NYSEMKT:ISR) shares were a budding breakout play. The 48% rally that's played out for ISR in the meantime unfurled right on cue. While overbought in the very short run, this small cap stock looks like it's earning the right to be compared to the likes of bigger brothers in the cancer-treatment space... names like Roche Holding Ltd. (OTCMKTS:RHHBY) or Theragenics Corporation (NYSE:TGX).
- [By James E. Brumley]
Ugh. It's fun to be right about a stock, but it's exhausting to be too right, too fast. Case in Point? IsoRay, Inc. (NYSE: ISR). Yours truly posted some bullish comments on ISR just a couple of days ago, explaining how that day's move above a key ceiling meant a new bull trend was underway, and more gains from that price would be far easier to muster. Well, good news for those who heeded the advice - IsoRay shares are up 44% today.
- [By Vanina Egea]
Strengthening portfolio and business stability is to be reinforced by the introduction of new products. Last December, Textron announced the successful first flight of the Scorpion Intelligence, Surveillance and Reconnaissance (ISR)/Strike aircraft. ��he Scorpion compares very favorably to more costly aircraft currently used for low-threat missions,��pilot Dan Hinson said. The new product is expected to accommodate the budget constraints and shifting mission requirements of the US Department of Defense. The same department has granted the firm an additional contract worth $22.5 million to "deprocess" Mobile Strike Force vehicles and train the Afghan Army.
Top 10 Biotech Stocks To Invest In Right Now: Protalix Biotherapeutics Inc (PLX)
Protalix BioTherapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its ProCellEx protein expression system, ProCellEx. Using its ProCellEx system, the Company is developing a pipeline of biosimilar or generic versions of recombinant therapeutic proteins based on its plant cell-based expression technology, which focuses pharmaceutical markets and that rely upon known biological mechanisms of action. ProCellEx protein expression system consists of a set of technologies and capabilities for the development of recombinant proteins, including advanced genetic engineering technology and plant cell-based protein expression methods. Its ProCellEx protein expression system is built on flexible custom-designed bioreactors made of polyethylene and optimized for the development of complex proteins in plant cell cultures. In June 2010, it had completed the preliminary phase I clinical trial of PRX-105.
Taliglucerase Alfa
Taliglucerase alfa is a plant cell expressed recombinant glucocerebrosidase enzyme (GCD) for the treatment of Gaucher disease. The Company has commenced pre-clinical studies of an oral form of taliglucerase alfa. Its oral taliglucerase alfa is a plant cell expressed form of GCD that is naturally encapsulated within carrot cells genetically engineered to express the GCD enzyme. Pre-clinical studies of oral taliglucerase alfa demonstrate the stability of the enzyme in the cell and the capacity of the cell�� cellulose wall to protect the enzyme against degradation in the digestive tract in an in-vitro model of the stomach and intestines. Additionally, rats fed with lyophilized carrot cells expressing GCD have accumulated the active enzyme in the target organs; the spleen and liver. As of December 31, 2010, the Company had completed Phase III Clinical Trial.
PRX-102
The Company is developing PRX-102, its plant cell expressed modified version of the recombinant ! alpha-GAL-A protein, a therapeutic enzyme for the treatment of Fabry disease. Fabry disease is a rare, hereditary, genetic lysosomal storage disorder in humans caused by an X-lined deficiency of the alpha-GAL-A enzyme. The Company is in the animal evaluation testing phase of the development of PRX-102, which tests are based on a mouse model for Fabry disease.
Acetylcholinesterase
Protalix Ltd. is a wholly owned subsidiary of the Company is licensed the rights to certain technology under a research and license agreement with Yissum Research and Development Company (Yissum) and the Boyce Thompson Institute, Inc. Pursuant to the agreement, the Company is developing PRX-105, a plant cell-based acetylcholinesterase (AChE) and its molecular variants for the use in several therapeutic and prophylactic indications, as well as in a biodefense program and an organophosphate-based pesticide treatment program.
As of December 31, 2010, its in-vitro experiments of PRX-105 have shown that the acetylcholinesterase enzyme in its ProCellEx protein expression system demonstrates biological activity on biochemical and cellular levels. In addition, early animal studies demonstrated that the acetylcholinesterase expressed in its ProCellEx protein expression system was able to treat animals exposed to the nerve gas agent analogues, both when injected with its acetylcholinesterase product candidate immediately before exposure or when injected after exposure. In March 2010, it initiated a preliminary phase I clinical trial of PRX-105, which the Company completed in June 2010.
pr-antiTNF
pr-antiTNF is a candidate for the treatment of certain autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing, spondylitis, psoriatic arthritis and plaque psoriasis. The Company has designed the antiTNF as pr-antiTNF. pr-antiTNF is a plant cell-expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), f! used to t! he Fc component of a human antibody domain. pr-antiTNF has an identical amino acid sequence to Enbrel and its in-vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner.
The Company competes with Genzyme, Actelion, Crucell N.V., Biolex, Inc., Chlorogen, Inc., Greenovation Biotech GmbH, Symbiosys, Novartis AG/Sandoz Pharmaceuticals, BioGeneriX AG, Stada Arzneimittel AG, BioPartners GmbH and Teva.
Advisors' Opinion:- [By Keith Speights]
Other investors might wish that Pfizer would use some of its cash to acquire a few smaller companies. Protalix BioTherapeutics (NYSEMKT: PLX ) has been mentioned as one possible candidate. The two companies already partner together on Gaucher disease drug Elelyso. In February, Protalix spurred rumors that Pfizer could be interested in buying the company after it announced that it had engaged Citigroup to pursue a "broad array of strategic alternatives."
- [By Maxx Chatsko]
Industrial biotech isn't the only industry headed to Brazil. Protalix (NYSEMKT: PLX ) entered into a technology transfer agreement with Brazil's Ministry of Health last week that will pay the company $280 million. The deal is big news for Protalix's first product, Elelyso/Uplyso, which was developed with partner Pfizer (NYSE: PFE ) . The treatment is approved as an enzyme replacement therapy, or ERT, for adults with type 1 Gaucher disease, and it marks a huge step forward for the future of biomanufacturing. In the following video, Fool contributor Maxx Chatsko explains what this means for the product's commercialization and the adoption of Protalix's novel plant cell-based expression system for therapeutic proteins.
Top 10 Biotech Stocks To Invest In Right Now: Cubist Pharmaceuticals Inc.(CBST)
Cubist Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The company markets CUBICIN (daptomycin for injection), a once-daily, bactericidal, intravenous, antibiotic with activity against gram-positive organisms, including methicillin-resistant staphylococcus aureus. Its clinical development product pipeline consists of CXA-201, which is in the phase III clinical trial for patients with complicated urinary tract infections; and in phase II clinical trial for patients with complicated abdominal infections. The company is also developing CXA-201 for the treatment of hospital acquired pneumonia. In addition, its product under development comprises CB-183,315, an oral, bactericidal lipopeptide with in vitro bactericidal activity against C. difficile, for the treatment of clostridium difficile-associated diarrhea (CDAD). Further , the company?s pre-clinical programs include therapies to treat various bacterial infections and agents to treat acute pain. Additionally, it promotes MERREM I.V. (meropenem for injection), a carbapenem class intravenous antibiotic, in the United States under a commercial services agreement with AstraZeneca Pharmaceuticals, LP; and DIFICID as the treatment for CDAD in adults under the co-promotion agreement with Optimer Pharmaceuticals, Inc. The company also has collaborations with Forma Therapeutics, Inc. to discover and develop antibacterial compounds; an agreement with the Broad Institute to transform natural products discovery; a collaboration with Hydra Biosciences, Inc., to develop ion channel drugs; and a collaboration agreement with Alnylam Pharmaceuticals, Inc., for the development and commercialization of Alnylam's RNAi therapeutics as a therapy for the treatment of respiratory syncytial virus. The company was founded in 1992 and is headquartered in Lexington, Mas sachusetts.
Advisors' Opinion:- [By Sean Williams]
What: Shares of Cubist Pharmaceuticals (NASDAQ: CBST ) , a biopharmaceutical company devoted to developing acute care therapies, added 12% following the announcement of its second-quarter earnings results.
- [By Jon C. Ogg]
Cubist Pharmaceuticals Inc. (NASDAQ: CBST) was raised to Outperform from Market Perform at Leerink Swann.
Diamondback Energy Inc. (NASDAQ: FANG) was downgraded to Hold from Buy at Canaccord Genuity.
- [By Victor Selva]
Forest Laboratories has a current ratio of 2.69% which is higher than the ones registered by Endo International Plc (ENDP), Valeant Pharmaceuticals International (VRX) and Cubist Pharmaceuticals Inc. (CBST). For investors looking for a higher ROE, Allergan Inc. (AGN) and Actelion Ltd. (ATLN.VX) are good options.
Top 10 Biotech Stocks To Invest In Right Now: Clovis Oncology Inc (CLVS)
Clovis Oncology, Inc. (Clovis) incorporated on April 20, 2009, is a Development-stage Company. The Company is a Biopharmaceutical Company. The Company focuses on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and additional international markets. The Company also focuses on the treatment of specific subsets of cancer populations. During the year ended December 31, 2010, the Company was in the process of developing three product candidates for which it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-cancer drug gemcitabine; CO-1686, an oral epidermal growth factor receptor (EGFR) mutant-selective inhibitor and CO-338, a poly ADP (Adenosine Diphosphate)-ribose polymerase (PARP) inhibitor. Effective November 19, 2013, Clovis Oncology Inc acquired the entire share capital of Ethical Oncology Science SpA.
CO-101 - a Lipid-Conjugated Form of the Anti-Cancer Drug Gemcitabine
CO-101 is designed to treat patients with pancreatic cancer whose tumors express low amounts of a membrane transporter protein on the surface of the cancer cell known as hENT1 and are thus expected to be resistant to standard gemcitabine-based therapy. Based on the published results of multiple studies assessing the correlation of hENT1 expression to survival outcomes in pancreatic cancer patients treated with gemcitabine, the Company estimates that approximately 40% to 50% of pancreatic patients express low levels of hENT1, and thus derive little or no benefit from gemcitabine therapy. CO-101 is in an international, randomized and controlled 360-patient study for the first-line treatment of metastatic pancreatic cancer. This open-label study compares CO-101 to gemcitabine as a first-line therapy in patients with metastatic pancreatic cancer. Clovis is partnered with Ventana Medical Systems for the development and commercialization of a companion diagnostic for the assessment of hENT1 levels.
CO-1686-an Oral EGFR Mutant-Selective ! Inhibitor
CO-1686 is an orally available, small molecule covalent inhibitor of the cancer-causing mutant forms of EGFR for the treatment of non-small cell lung cancer (NSCLC). CO-1686 targets both the initial activating EGFR mutations as well as the primary resistance mutation, T790M, it treats both first- and second-line NSCLC patients with EGFR mutations. Such initiating activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% of NSCLC cases in East Asian patients. Following treatment with approved NSCLC therapies, Tarceva (erlotinib) or Iressa (gefitinib), both known as tyrosine kinase inhibitors (TKIs), approximately half of these patients develop the T790M mutation.
The Company focuses on the development of CO-1686 as both a second-line therapy for EGFR-mutated NSCLC patients who become resistant to TKIs due to the emergence of the T790M secondary mutation and as a first-line treatment for EGFR-mutated NSCLC. Clovis is partnered with Roche Molecular Systems for the development and commercialization of a companion diagnostic for identification of EGFR mutations.
CO-338-a PARP Inhibitor
CO-338 is a small molecule PARP inhibitor that the Company focuses to develop as both monotherapy and in combination with chemotherapeutic agents for the treatment of selected cancer patients. CO-338 is in a Phase I clinical trial to determine the maximum tolerated dose of oral CO-338 that can be combined with intravenous, or IV, platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing investigator-initiated trials, using the IV formulation of CO-338: a Phase I/II study in germ-line BRCA mutant breast and ovarian cancer and a Phase II study in the adjuvant treatment of germ-line BRCA mutant and triple-negative breast cancer. The Company also focuses on initiating a Phase I monotherapy study of the oral formulation, to determine an appropriate dose and schedule.!
The Company competes with Eli Lilly, Teva Pharmaceutical Industries, APP Pharmaceuticals, AB Science SA, Amgen Inc., Astellas Pharma, BioSante Pharmaceuticals, Inc., Celgene Corporation, Immunomedics, Inc., Lorus Therapeutics, Threshold Pharmaceuticals, Inc., Boehringer Ingelheim, Pfizer, Sanofi-Aventis, Astra Zeneca, Abbott, Merck, Eisai, Cephalon and Biomarin.
Advisors' Opinion:- [By John Udovich]
Bubble talk, biotech IPO setbacks plus news�about small cap biotechs like Intrexon Corp (NYSE: XON) and TNI BioTech (OTCMKTS: TNIB) have dominated biotech news this week or in recent weeks. Just consider the following news:
Why There is No Biotech Bubble & Where to Look for Value in Biotech. Marshall Gordon, the Director and senior health-care analyst of ClearBridge Investments, was recently interviewed by Barron�� where he stated his belief that there is no biotech bubble because biotech stocks have delivered new drugs and have shown an ability to innovate. With that said, he added that the sector got ahead of itself while some biotechs suffered setbacks plus hedge funds decided to trim risk from their portfolios. Nevertheless, Marshall likes or is watching mid cap biotechs BioMarin Pharmaceutical Inc (NASDAQ: BMRN) and Pharmacyclics, Inc (NASDAQ: PCYC) along with small cap biotechs�Pacira Pharmaceuticals Inc (NASDAQ: PCRX) and Clovis Oncology Inc (NASDAQ: CLVS). He also added that recent biotech IPOs have been lesser quality names than earlier offerings. A Trio of Biotech�IPO Setbacks. FierceBiotech has�summarized how a trio of biotech IPO have suffered setbacks. Specifically, Relypsa (NASDAQ: RLYP), a late-stage biotech developing a treatment for hyperkalemia,�slashed its asking price on 6.9 million shares to $12 a share to raise $82 million�from a range of $16 to $19 a share while�Xencor (NASDAQ: XNCR), a biotech developing antibodies for severe autoimmune/allergic diseases and cancer,�has dropped its IPO price to $7 a share to raise $75 million from a range of $14 to $16. Meanwhile, Celladon, which is developing a first-in-class gene therapy for patients with systolic heart failure, has postponed its IPO citing poor market conditions. Coming�Biotech IPOs. Nevertheless, FierceBiotech has noted that GeNO Healthcare (NASDAQ: GNO) is looking to raise $50 million for its�new, patient-friendly approach for delivering inhaled nitric oxide on the - [By Brian Orelli]
Plenty of data was presented at the American Society for Clinical Oncology meeting over the weekend, causing the first set of ASCO pops, but Clovis Oncology (NASDAQ: CLVS ) looks like the clear winner, more than doubling today as the company presented data on its two cancer drugs rucaparib and CO-1686.
- [By John Udovich]
On Wednesday, small cap cancer stock Clovis Oncology Inc (NASDAQ: CLVS) soared 16.68% after announcing a $200 million cancer deal plus the biotech has more than tripled since late 2011, meaning it might be time to take a closer look at what�� driving the stock higher as well as look at the performance of biotech ETF benchmarks like iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB) and SPDR S&P Biotech ETF (NYSEARCA: XBI).
Top 10 Biotech Stocks To Invest In Right Now: Cellular Dynamics International Inc (ICEL)
Cellular Dynamics International, Inc., incorporated on November 16, 2007, develops and manufactures fully functioning human cells in industrial quantities to precise specifications. The Company�� iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products). Customers use its iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics. The Company�� iCell product line includes four different cell types: cardiomyocytes, neurons, hepatocytes and endothelial cells. The Company is actively developing an additional seven different cell types. iCell products are a consumable designed to be used once and then reordered.
The Company manufactures its iCell products from its iPSCs. An iPSC is a cell that has the ability both to replicate indefinitely and to be transformed into any cell type in the human body. The Company�� iCell O/S consists of six products, which include iCell Cardiomyocytes, iCell Neurons, iCell Endothelial Cells, iCell Hepatocytes and MyCell.
Advisors' Opinion:- [By John Udovich]
Stem cells may not be in the news much�as the sector has moved beyond the use of embryotic�ones, but small cap stem cell stocks Cellular Dynamics International Inc (NASDAQ: ICEL), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been fairly active over the past several trading days as ICEL went public, ISCO raised additional funding and BRTX grabbed more attention:
Top 10 Biotech Stocks To Invest In Right Now: Genomic Health Inc (GHDX)
Genomic Health, Inc. (Genomic Health), incorporated in August 2000, is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its Oncotype DX platform utilizes quantitative genomic analysis known as reverse transcription polymerase chain reaction (RT-PCR), in standard tumor pathology specimens to provide tumor-specific information, or the oncotype of a tumor. As of February 2012, Oncotype DX was evaluated in invasive breast cancer in 13 clinical studies involving more than 4,000 breast cancer patients worldwide. Genomic Health offers its Oncotype DX tests as a clinical service, where it analyzes the expression levels of genes in tumor tissue samples and provide physicians with a quantitative gene expression profile expressed as a single quantitative score, which it calls a Recurrence Score, for invasive breast cancer and colon cancer and a DCIS Score for DCIS. Its Oncotype DX breast cancer test analyzes the expression levels of 21 genes and Oncotype DX colon cancer test analyzes the expression levels of 12 genes. In March 2012, the Company established a wholly owned subsidiary, InVitae Corporation.
Oncotype DX Platform
The Company�� Oncotype DX platform uses its RT-PCR approach to improve cancer treatment decisions. Its diagnostic approach correlates gene expression to clinical outcomes and provides an individualized analysis of each patient's tumor. The Company has built a diagnostic infrastructure that allows it to move from research into development through to processing actual patient samples in its clinical reference laboratory. The Company offers Oncotype DX tests as clinical laboratory services. Its technology allows the Company to analyze tumor tissue samples in its clinical reference laboratory and provide physicians with genomic information specific to the patient'! s tumor. It analyzes tissues that are handled, processed and stored under routine clinical pathology laboratory practices.
Oncotype DX Breast Cancer Test
To develop its Oncotype DX breast cancer test, the Company evaluated 250 genes in three independent clinical studies, which identified a 21-gene panel whose composite gene expression profile can be represented by a breast cancer Recurrence Score. The Company conducted studies of its Oncotype DX breast cancer test with clinical samples from postmenopausal women with invasive breast cancer who were treated with aromatase inhibitors. In March 2010, the Journal of Clinical Oncology published results from a European study using its test to analyze tumor samples from over 1,200 patients in the ATAC (Arimedix, Tamoxifen, Alone or in Combination) trial, which established the use of aromatase inhibitors for adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer. The study demonstrated that, along with other standard measures, such as tumor size, its Oncotype DX breast cancer test contributes independently to provide a more complete picture of prognosis for N- and N+ patients treated with aromatase inhibitors.
In December 2011, the Company presented positive results from the ECOG E5194 DCIS clinical validation study at SABCS. The study met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score can predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. In December 2011, the Company made Oncotype DX available for patients with ductal carcinoma in situ (DCIS), of the breast, a pre-invasive form of breast cancer. The launch of Oncotype DX for DCIS patients was based on positive results presented from a clinical validation study of Oncotype DX breast cancer test in patients with DCIS, conducted by the Eastern Cooperative Oncology Group (ECOG), a clinical trials cooperative! group su! pported by the National Cancer Institute.
Oncotype DX Colon Cancer Test
The Company developed its gene panel by identifying 761 cancer-related genes through review of existing research literature and computer analysis of genomic databases. The 761 candidate genes were also examined to determine whether they would be useful beyond other key variables including tumor stage, tumor grade, lymph nodes examined and MMR/MSI. It selected a final set of 12 genes, which were then independently evaluated in a validation study of over 1,400 stage II colon cancer patients from the Quick and Simple and Reliable (QUASAR), randomized study of adjuvant chemotherapy in the United Kingdom. This international, multi-center randomized trial examined the recurrence risk and the benefit associated with 5-fluorouracil/leucovorin, or 5FU/LV, adjuvant chemotherapy. Gene expression was quantified by RT-PCR from manually microdissected FPE primary colon cancer tissue, and recurrence-free interval, disease-free survival and overall survival were analyzed. In January 2012, the Company presented positive results of the first clinical decision making study of the Oncotype DX colon cancer test that shows that Recurrence Score result has a significant impact on treatment recommendations for stage II colon cancer patients.
The Company competes with General Electric Company, Hologic, Inc., Novartis AG, Myriad Genetics, Inc., Qiagen N.V., Response Genetics, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Roche Holding, Ltd, Siemens AG and Johnson & Johnson.
Advisors' Opinion:- [By Jon C. Ogg]
Genomic Health Inc. (NASDAQ: GHDX) was downgraded to Underperform from an already cautious Neutral and the price target was cut to $33 from $36 by Bank of America�Merrill Lynch.
- [By Keith Speights]
Genetic testing stands out as one current example of how scientific advances can help reduce medical costs. Genomic Health (NASDAQ: GHDX ) makes genetic diagnostic tests for�breast, colon, and prostate cancer. Half of the patients diagnosed with prostate cancer each year actually have a very low risk of the cancer progressing. However, 90% of these low-risk patients still undergo surgery or radiation -- at a cost of tens of thousands of dollars per patient. Genomic Health's genetic test helps identify which patients really need more extensive treatment and holds the potential to reduce overall costs.
- [By Sean Williams]
What: Shares of Genomic Health (NASDAQ: GHDX ) , a provider of genome-based clinical diagnostic tests, popped as much as 10% following the release of its first-quarter results.
No comments:
Post a Comment