News Article | December 19, 2016
SAN DIEGO--(BUSINESS WIRE)--Reflexion Health Inc., a digital healthcare company, today announced the appointment of Sudipto Sur, Ph.D. to chief technology officer, effective January 3, 2017. Reporting to Reflexion Health CEO Joseph (Joe) Smith, Sur will lead Reflexion Health’s technology organization and will champion the next phase of the company’s innovation and growth. Dr. Sur is a seasoned technology leader and engineer. As CTO, he will apply his extensive experience developing pioneering solutions in robotics, vision systems, analytics, medical devices, and diagnostics to advance Reflexion Health’s technology platform. He will also serve as a member of Reflexion Health’s executive leadership team where he will help drive the company’s vision while enhancing Reflexion Health’s engineering and digital capabilities as well as its IT infrastructure. “As we prepare to expand our product platform and help a larger, more diverse patient population, we are thrilled to welcome Sudipto to our growing team,” said Smith, M.D. Ph.D., President and CEO of Reflexion Health. “With his significant expertise creating next-generation technology solutions and his ability to manage development processes in a regulated environment, Sudipto’s experience and leadership will accelerate our ability to improve clinical outcomes at a lower cost and on broader scale.” Dr. Sur brings more than 20 years of engineering, technology development and management experience to the Reflexion Health team. Most recently, he served as chief information officer at Signal Genetics, Inc., a commercial-stage molecular diagnostics company, where he developed an IT infrastructure for cloud-based clinical analytics and billing systems. Prior to Signal, Dr. Sur was founder and CEO of two companies: Anssur Corp, an engineering and software services provider for analytics and medical robotics, and Miralex Systems Inc., where he led the development of next-generation human computer interface platforms. He also served as director of research and development at Sequenom. Dr. Sur received his Ph.D. and M.S. in control systems and robotics from the California Institute of Technology. He received his B.S. in mechanical engineering from the Indian Institute of Technology in Mumbai, India. About Reflexion Health, Inc. Reflexion Health is a digital healthcare company dedicated to transforming traditional medicine and improving clinical outcomes by using innovative technology solutions to deliver patient-centered care at reduced costs. VERA™, Reflexion Health’s signature solution, is an FDA-cleared Virtual Exercise Rehabilitation Assistant that detects motion and remotely monitors the effectiveness of prescribed physical therapy in real-time. VERA brings the guidance of a physical therapist into the home to coach and motivate patients through recovery from joint replacement surgery or as a preventative therapy to reduce falls. For more information, visit www.reflexionhealth.com and follow us at @ReflexionHealth.
News Article | December 15, 2016
DENVER--(BUSINESS WIRE)--Colorado’s life science sector wraps up a year marked by an expanded presence for a global biologics manufacturer, notable regulatory successes for companies developing breakthrough biologics, drugs and medical devices, significant partnerships created to draw on the state’s collaborative spirit and commitment to innovation and notable grant-making and fundraising activities. New numbers from Colorado’s Office of Economic Development and International Trade (OEDIT) show the long-term impact of investment in bioscience. In 2016, OEDIT provided $8.68 Million to Colorado bioscience companies through the Advanced Industries (AI) Grant Program. Since inception, this industry-critical program supporting the bioscience sector in Colorado has awarded $45.9 Million in grants, and continues to make an economic impact in the state, creating: April Giles, President and CEO of Colorado BioScience Association says: “From the long-term success of the AI grant program, to innovative start-ups achieving critical financing and regulatory goals, to a major global manufacturer choosing Colorado for continued expansion, our state’s life science industry will look back on 2016 as milestone year. Colorado is recognized as an epicenter for big ideas and major breakthroughs, with a collaborative and supportive community of people committed to improving human health and quality of life.” Many Colorado bioscience organizations met significant business and regulatory milestones, raised funds and received grants. Notable examples of the 2016 successes achieved by CBSA members include: Colorado companies raised hundreds of millions of dollars to invest in research and development and support commercialization. Examples include: Innovators at all stages of development received grants, donations and awards from individuals, government entities and industry organizations. Access to these sources of non-dilutive funding is critical to support research and continued industry growth. AstraZeneca, a global biologics manufacturer expanded its Colorado presence through the acquisition of a second Colorado site. The company purchased the former Amgen, Inc. biologics manufacturing property in Longmont to support operations at its Boulder site, acquired in 2015. Colorado companies received at least ten FDA approvals or clearances on biologics, medical devices and drugs. Additionally, the FDA accepted several New Drug Applications (NDAs) and granted one Investigational Device Exemption (IDE) to companies based in our state. Additionally, at least five companies were granted U.S. patents or European CE marks. Four Colorado companies announced mergers and acquisitions in 2016. miRagen and Signal Genetics, Inc. (Nasdaq: SGNL) entered into a definitive merger agreement to form miRagen Therapeutics, Inc., allowing miRagen to become a public company, trading under the Nasdaq ticker symbol MGEN when the transaction becomes final. Additionally, Schryver Medical Sales and Marketing, LLC acquired Professional Clinical Laboratory, Inc. (“ProLab”) to bolster its presence in the Texas market; Venaxis Inc. (Nasdaq: APPY) acquired Boulder-based BiOptix Diagnostics, Inc.; and Sartorius acquired ViroCyt to expand the lab products and services offered by Sartorius. Colorado’s reputation as an epicenter for big ideas and a collaborative culture attracted new centers focused on innovation and partnerships created to tackle major healthcare challenges. Catalyst HTI – The industry integrator focused on health tech innovation, scheduled to open in early 2018, announced several anchor tenants, including University of Colorado Anschutz, Terumo BCT, American Diabetes Association and Hitachi Consulting. StartUp Health – Launched its Rocky Mountain innovation hub, StartUp Health Colorado in partnership with Children’s Hospital Colorado, University of Colorado Anschutz and UCHealth to support healthcare entrepreneurs from around the world. Catholic Health Initiatives and Dignity Health – Created the Precision Medicine Alliance to offer patients of both healthcare systems faster and more accurate diagnostic and treatment protocols based on their genetic and molecular profile information. PharmaJet – Announced a multi-year partnership as part of the World Health Organization’s focus on eradicating polio, using the Colorado company’s Tropis device to administer medication through the skin without needles. Colorado’s almost 725 life science organizations range from those moving from early-stage research and development, through clinical trials and into full-fledged commercialization. Those companies are responsible for close to 600 commercial products developed in Colorado. Colorado BioScience Association champions life science. We serve as the hub of Colorado’s thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. From promising young companies to established corporations and institutions, we provide opportunities for networking, education and professional development. We grow the bioscience workforce and lead business expansion policies to advance the industry in our state. CBSA represents more than 350 member organizations, including biotechnology, pharmaceutical, medical device, diagnostic, ag bio and mobile digital health companies, research and academic institutions and service providers. Learn more about us at http://www.cobioscience.com.
News Article | December 1, 2016
Hematological Malignancies Market analysis is provided for global market including development trends by regions, competitive analysis of the Hematological Malignancies market. Hematological Malignancies Industry report focuses on the major drivers and restraints for the key players. “Hematological Malignancies: Multiple Myeloma (Mm) – Early and Robust Diagnosis Along With New Treatment Options Can Have Considerable Impact on Management of the Disease” report speaks about the manufacturing process. The process is analysed thoroughly with respect four points Manufacturers, regional analysis, Segment by Type and Segment by Applications and the actual process of whole Hematological Malignancies industry. Over the past decade, Proteasome inhibitor and the immunomodulatory drugs have become the cornerstone of treatment for pts with Multiple Myeloma (MM) resulting in improved survival. However, eventually all pts relapse and use of modern diagnosis will enable risk stratification to help distinguish pts along the spectrum of the condition. This can aid in the selection of new treatment options for Relapsed/ Refractory Multiple Myeloma (RRMM) to further improve survival and quality of life of each patient. Two new drugs have successfully fulfilled this need – POMALYST/ IMNOVID (pomalidomide – POM, Celgene, approved) and Kyprolis (carfilzomib-CFZ, Amgen/ Ono Pharma – JP, approved). While novel targets address unmet need, the pertinent Question remains – is there a need for further improvement? What should be the diagnosis criteria and/or novel imaging / diagnostic tools that can further stratify a pts’ risk profile? Ask Sample PDF @ http://www.absolutereports.com/enquiry/request-sample/10437984 In this report, we highlight the emerging new treatments in RRMM /NDMM, which includes combination of small molecules and biologics, and novel approach of molecular analysis of MM. This report also provides M&A deals in the diagnostic, cancer area along with growing market opportunities. Furthermore, the competitive landscape of NDMM and RRMM is also highlighted. The rivalry prevalent in the global onco-diagnostic and therapeutic MM market is quite fierce with numerous local and global players contenting for the market share. On the global diagnostic front, the key players are Roche, Abbott Diagnostics, and Illumina; and in Tx area, the key players are Celgene, Takeda pharma, Amgen, Novartis, and JNJ While targeting unmet needs in the treatment of hematological malignancies/ cancer through innovative drug development strategies have witnessed favorable outcomes, the specific choice of the therapies is dependent on the identification of important genomic alterations in cancerous cells that allow for the tumor’s sub classification. Precision medicine approaches in myeloma require fast, robust, and practicable molecular diagnostic tools, and the current diagnostic standard iFISH (interphase fluorescence in situ hybridization) is unable to fulfill any of these criteria. Integration of Diagnostics into therapeutic products/ industry has potential to improve trial design, enhance safety profile, enhance therapeutic efficacy, accelerate trial outcome, and increase commercial success. However, there are few hurdles which are also associated with new model, such as understanding the diagnostic industry, complex trial execution, seeking a ‘right’ diagnostic partner, managing the co-development process, regulatory uncertainty around companion diagnostics and intellectual property issues. Two new drugs have successfully fulfilled this need – POMALYST/ IMNOVID (pomalidomide – POM, Celgene, approved) and Kyprolis (carfilzomib-CFZ, Amgen/ Ono Pharma – JP, approved). While novel targets address unmet need, the pertinent Question remains – is there a need for further improvement? What should be the diagnosis criteria and/or novel imaging / diagnostic tools that can further stratify a pts’ risk profile? 1. Executive Summary 2. Disease Overview, Diagnosis, and Current Treatment 2.1 Overview of Diagnostic tools for Multiple Myeloma 2.2 Diagnostic Criteria of Myeloma and Recent Amendment 2.3 Diagnostic Approaches for Multiple Myeloma 2.3.1 Molecular pathogenesis of Myeloma 2.3.2 Unmet Need 2.3.3 New Diagnostics Perspective and Technologies a ‘Companion’ Diagnostics (CDx) b Genome-wide array c RAN based technologies d Next-Generation Sequencing (NGS) technology 3. Diagnostic Tools for Multiple Myeloma 3.1 Affymetrix GeneChip 3.2 SkylineDx MMprofiler 3.3 AgenaBio iPLEX Genotyping 3.4 Signal Genetics MyPRS 3.5 Cancer Genetics Genomic Products 3.6 Illumina NGS 3.7 NeoGenomics CLIA-certified Cancer Test 3.8 Exiqon microRNA PCR 3.9 Regulus Therapeutics microRNA Marker 3.10 Rosetta Genomics Cancer Origin Test 3.11 Sequenta LymphoSIGHT Platform 4. M&A Deals and Market Opportunity in Diagnostic Space 5. Current Therapies 5.1 Newly Diagnosed Multiple Myeloma (NDMM) 5.1.1 Competitive Landscape for NDMM 5.2 Relapsed and/or Refractory Multiple Myeloma (RRMM) 5.2.1 Competitive Landscape for RRMM 5.3 Approved Therapies 5.3.1 Revlimid 5.3.2 Velcade 5.3.1 Kyprolis 5.3.2 POMALYST 5.1 Data Comparison 5.4.1 Newly Diagnosed Multiple Myeloma (NDMM) 5.4.2 Relapsed and/or Refractory Multiple Myeloma (RRMM) 6. Novel Targets 6.1 Monoclonal Antibodies 6.1.1 Elotuzumab 6.1.2 Situximab 6.1.3 Daratumumab 6.1.4 MOR202 6.1.5 SAR650984 6.1.6 BI-505 6.1.7 BHQ880 6.1.8 CT-011 6.1.9 IPH2101/ Lirilumab 6.1.10 BMS-936564 (ulocuplumab) 6.2 Small Molecules 6.2.1 Panobinostat 6.2.2 Ixazomib (MLN9708) 6.2.3 Aplidin (plitidepsin) 6.2.4 ARRY-520 (filanesib) 6.2.5 Oprozomib 6.2.6 KPT-330 (selinexor) 6.2.7 SNS01-T 6.2.8 Ibrutinib 6.2.9 Ricolinostat 6.2.10 Afuresertib 6.2.11 KW-2478 6.2.12 BT-062 7. Clinical Milestones 9. Launch Timeline and Commercial Opportunity of Late-Stage Pipeline 10. M&A/ Licensing Deals and Unpartnered Product Opportunities Absolute Reports is an upscale platform to help key personnel in the business world in strategizing and taking visionary decisions based on facts and figures derived from in depth market research. We are one of the top report resellers in the market, dedicated towards bringing you an ingenious concoction of data parameters.
News Article | November 28, 2016
CARLSBAD, Calif., Nov. 28, 2016 (GLOBE NEWSWIRE) -- Signal Genetics, Inc. (NASDAQ:SGNL), a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced that it has received a letter from The NASDAQ Stock Market LLC notifying the Company that it has regained compliance with the NASDAQ Capital Market’s minimum bid price continued listing requirement. The letter noted that as of November 21, 2016, the Company evidenced a closing bid price of its common stock in excess of the $1.00 minimum requirement for at least ten consecutive trading days. Accordingly, the Company has regained compliance with NASDAQ Marketplace Rule 5550(a)(2) and NASDAQ considers the matter closed. Signal, headquartered in Carlsbad, California, is a commercial stage, molecular genetics diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer. Signal's mission is to develop, validate and deliver innovative diagnostic services that enable better patient-care decisions. Signal was founded in January 2010 and became the exclusive licensee in its licensed field to the renowned research on multiple myeloma performed at the University of Arkansas for Medical Sciences, in April 2010. Cautionary Statement Relating to Forward-Looking Information for the Purpose of “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995 Statements contained in this release, other than statements of historical fact, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “expects,” “believes,” “may,” “intends,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the MyPRS® diagnostic test constitute forward-looking statements. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation our ability to raise additional capital to continue our development programs, our ability to successfully develop potential products, our ability to obtain, maintain and protect intellectual property rights (including for MyPRS®), as well as other risks associated with the process of discovering, developing and commercializing diagnostic services to help physicians make informed decisions concerning the care of their patients suffering from cancer. These and other risks are described in detail in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2015 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. All forward-looking statements contained in this release speak only as of the date on which they were first made by us, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after such date. Additional Information about the Proposed Merger between Signal Genetics, Inc. and Miragen Therapeutics, Inc. and Where to Find It In connection with the previously disclosed proposed merger between Signal Genetics, Inc. and Miragen Therapeutics, Inc., Signal and Miragen intend to file relevant materials with the Securities and Exchange Commission, or the SEC, including a registration statement on Form S-4 that will contain a proxy statement/prospectus/information statement. Investors and security holders of Signal and Miragen are urged to read these materials when they become available because they will contain important information about Signal, Miragen and the proposed merger. Investors and security holders are urged to read the proxy statement/prospectus/information statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger. The proxy statement/prospectus/information statement and other relevant materials (when they become available), and any other documents filed by Signal with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Signal by directing a written request to: Signal Genetics, Inc., 5740 Fleet Street, Carlsbad, CA 92008, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement/prospectus/information statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger. This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Van Laar R.,Signal Genetics |
Flinchum R.,Signal Genetics |
Brown N.,Signal Genetics |
Ramsey J.,Signal Genetics |
And 4 more authors.
BMC Medical Genomics | Year: 2014
Background: Widespread adoption of genomic technologies in the management of heterogeneous indications, including Multiple Myeloma, has been hindered by concern over variation between published gene expression signatures, difficulty in physician interpretation and the challenge of obtaining sufficient genetic material from limited patient specimens. Methods. Since 2006, the 70-gene prognostic signature, developed by the University of Arkansas for Medical Sciences (UAMS) has been applied to over 4,700 patients in studies performed in 4 countries and described in 17 peer-reviewed publications. Analysis of control sample and quality control data compiled over a 12-month period was performed. Results: Over a 12 month period, the 70-gene prognosis score (range 0-100) of our multiple myeloma cell-line control sample had a standard deviation of 2.72 and a coefficient of variance of 0.03. The whole-genome microarray profile used to calculate a patient's GEP70 score can be generated with as little as 15 ng of total RNA; approximately 30,000 CD-138+ plasma cells. Results from each GEP70 analysis are presented as either low (70-gene score <45.2) or high (≥45.2) risk for relapse (newly diagnosed setting) or shorter overall survival (relapse setting). A personalized and outcome-annotated gene expression heat map is provided to assist in the clinical interpretation of the result. Conclusions: The 70-gene assay, commercialized under the name 'MyPRS®' (Myeloma Prognostic Risk Score) and performed in Signal Genetics' CLIA-certified high throughput flow-cytometry and molecular profiling laboratory is a reproducible and standardized method of multiple myeloma prognostication. © 2014 van Laar et al.; licensee BioMed Central Ltd.
News Article | November 1, 2016
BOULDER, Colo. & CARLSBAD, Calif.--(BUSINESS WIRE)--miRagen Therapeutics and Signal Genetics Sign Merger Agreement