South San Francisco, CA, United States
South San Francisco, CA, United States

Monogram Biosciences Inc. , a wholly owned subsidiary of LabCorp, is an international biotechnology laboratory located in South San Francisco, California, USA. Monogram develops and markets assays to help guide and improve the treatment of infectious diseases and cancer. Virologic was founded in 1996 by Daniel Capon, Ph.D., Martin Goldstein and Robert S. Capon. The company went public in 2000.Monogram was acquired by Laboratory Corporation of America in June 2009. Wikipedia.


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The invention provides a method for determining whether a human immunodeficiency virus is likely to be have enhanced ability to enter a cell expressing CD4 and CXCR4 relative to a reference HIV. In certain aspects, the methods comprise detecting one or more amino acids in an envelope protein of the HIV associated with enhanced ability to enter CD4- and CXCR4-expressing cells and determining that the HIVs ability to enter such cells is enhanced relative to a reference HIV, e.g., an HIV that does not comprise such amino acid(s).


NEW YORK, May 11, 2017 /PRNewswire/ -- This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments. The report is supported by over 360 tables & figures over 397 pages. The personalized medicine (global & USA) market is presented as follows: Read the full report: http://www.reportlinker.com/p03118741/Personalized-Medicine-Targeted-Therapeutics-and-Companion-Diagnostic-Market-to-Strategic-Analysis-of-Industry-Trends-Technologies-Participants-and-Environment.html • By Company (e.g., Qiagen, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD) • By Segment (Targeted therapeutics, Companion Diagnostics, Liquid Biopsies) • By Sub-market (Companion diagnostic, targeted cancer therapeutic, medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy) • By Therapy (Cancer, Cardiovascular, Infectious Disease) Key Opinion Leaders that contributed to interview questions within the report include: • Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group • Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James's Hospital and Trinity College Dublin, Ireland • Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Department of Veterans Affairs, Washington DC • Elaine Kenny, PhD, Founder, Elda Biotech, Dublin 2, Ireland • Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine • Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine • David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine • Deborah Phippard, PhD, Vice President, Research, Precision for Medicine • Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine A wealth of financial data & business strategy information is provided including: • Company financials, sales & revenue figures • Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies • Business Model Strategies for Providers. Provider Systems and Academic Medical Centres • Business Model Strategies for Payers & Governments • Private and Public Funding and Personalized Medicine Reimbursement • Revisions to Current Payment Systems and intellectual property • How to Gain Market Penetration in the EU • Cost-effectiveness and Business Value of Personalized Medicine • Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations) • Comprehensive account of company product portfolios & kits SWOT, Economic & Regulatory Environment specifics include: • Key strengths, weaknesses and threats influencing leading player position within the market • Technologies driving the market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing) • Top fastest growing market segments and emerging opportunities • Top pharmaceutical companies within the IPM by market share and revenue • Comprehensive product portfolios, R&D activity and pipeline therapeutics • M&A activity and future strategies of top personalized medicine pharmacos • Personalized Medicine Regulation (USA, UK, Germany, France, Spain, Italy) • CE-marked Personalized Medicine/Diagnostic Tests • FDA Advances in Personalized Medicine Regulation This report highlights a number of significant pharmacos and gives details of their operations, products, financials and business strategy. • 23andMe • Abbott Laboratories • Abbott Molecular Inc. • Admera Health (GENEWIZ) • Affymetrix • Agendia • Alere • Amgen • Astex Pharmaceuticals • AstraZeneca • Atossa Genetics • Becton Dickenson • bioMerieux • BristolMyersSquibb • Cancer Genetics • Celera (Quest Diagnostics) • Celldex Therapeutics • Claritas Genomics • CuraGen • Danaher (Leica Biosystems) • deCode Genetics (Amgen) • Foundation Medicine • EDP Biotech • Eli Lilly • ELDA BioTech • Eisai • Genelex • GlaxoSmithKline • Human Longevity Inc (Cypher Genomics) • HalioDx • Ikonisys • Illumina • InterGenetics • Johnson & Johnson • LabCorp • Life Technologies • Merck • MDxHealth • MolecularMD Corporation • Monogram Biosciences • Myriad • Nodality • Novartis MDx • Orion Genomics • Oxford BioTherapeutics • NanoString Technologies • Pfizer • Qiagen • Roche Molecular Diagnostics • Sanofi • SensiGen • Siemens Healthcare Diagnostics • Takeda • Thermo Fisher Scientific • Transgenomic • Ventana (Roche) • Vermillion (Ciphergen) • Vertex Pharmaceuticals What you will gain: • An in-depth understanding of the global personalized medicine market and it's environment • Current market facts, figures and product lines of key players in the industry • Emerging trends in key markets such as the US, UK, Germany and France • Knowledge of how the personalized medicine market will integrate into the global healthcare market • Technical insights into new generation sequencing technologies and ultra-high throughput sequencing • Updates on bioinformatics, high throughput systems, genetic analysis kits, companion diagnostics and future technologies • FDA approved pharmacogenetic tests and recognized biomarkers • Information on key government and regulatory policies • Strategies on how to adapt and restructure current business models to this industry This report tackles key concerns to the personalized medicine market such as: • Lack of regulatory policy and legislation in the US and Europe • Reimbursement schemes and payers concerns • Transition of investigational diagnostic assays and therapeutics to clinical practice • Direct to consumer (DTC) test kits and implications for the public Who should read this report? • Pharmaceutical, biotechnology and diagnostic companies (CEOs, VPs, Business Development, C-Suite)with an interest in personalized medicine • Industry professionals and business strategists will discover key information to propel their policies • Investors will gain inside information to dominant players in the industry and future forecasts • Scientists will get a business perspective and industry insight into how scientific breakthroughs influence the market environment This report will tell you if the companies mentioned are: • Strong, competitive players • Pooling their resources for specific growth and therapeutic areas • Investing strategically in R&D • Have a history of strategic M&A activity This detailed report is supported with 360 figures and tables over 397 pages and profiles the main pharmacos in personalized medicine. Benefits of Investing in our Cutting-Edge Reports: - Clients receive complementary content* with mid-level and enterprise wide licences - Post-sale complementary consultation with senior expert analyst is included - Use of tables and figures in your own reports and presentations is permitted - Each report provides straight-talking strategic analysis & sector intelligence - All reports are updated each quarter to give you the most up-to-date information Executive Summary Kelly Scientific forecasts that the companion diagnostic and targeted therapeutic submarkets of the personalized medicine industry were worth $113 billion in 2016, and will hit over $162 billion by 2021 with a CAGR of 8.74%. The total personalised therapeutic market, for all indications, will be worth $x billion by 2021, with a CAGR of x%. Currently it is estimated that the companion diagnostic segment is worth $x billion globally, mainly coming from oncology, cardiovascular and infectious disease (HIV/HCV) tests. This is set to rise vertically over the next five years and by 2021 will be worth over $x billion, with a CAGR of x%. This study details a comprehensive financial and strategic review of key players in the personalized medicine industry. Significant drivers and restraints of this market are revealed and market opportunities and challenges are identified. Disruptive technologies that are propelling the personalized medicine and companion diagnostic market are scrutinized. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in key markets such as the US, UK, Germany and France are elucidated and analysed. This study reveals market figures of the overall personalized medicine market and also sub-market figures with respect to companion diagnostics, targeted cancer therapeutics, medical technologies, pharmacogenomics, consumer genomics, molecular diagnostics and liquid biopsies. Specific indication markets are also included such as cancer, cardiovascular and infectious disease. The report provides value and growth of the global personal therapeutics market from 2017-2021. Also historic figures back to 2014 are given to illustrate growth. As the personal targeted therapeutics market is part of the overall personalized medicine market, the companion diagnostics market is also included in the report The report goes into detail regarding different indications, mainly oncology drugs as these hold most market share, and also cardiovascular and infectious disease markets. It contains specific data for both the targeted therapeutic and companion diagnostic sections of the personalized medicine market. These sections are then further divided into indications – Oncology, Cardiovascular and Infectious Disease The report also analyses the market with regards to major players such as GSK, Amgen, Sanofi, Novartis, Janssen, BMS, Pfizer, AstraZeneca, Roche. To give an comprehensive view of how the PM market relates to associated markets, a number of these are analysed and forecast to 2021 (medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy). For example, data from the targeted therapeutics section includes the following specifics: • Targeted Therapeutic Sales Revenue, All Indications (by Company, GSK, Amgen, Sanofi, Novartis, Janssen, BMS, Pfizer, AstraZeneca, Roche). • Global Targeted Therapeutic Market, All Indications, Forecast 2014-2021 • Global Oncology Targeted Therapeutics Forecast 2014-2021 • HER-2 Positive Breast Cancer Targeted Therapeutic Market Forecast 2014-2021 • Oncology Targeted Therapeutic Market Forecast By Drug 2014-2021 (Herceptin Erbitux Gilotrif Gleevec Mekinist Tafinlar Zelboraf Tarceva Xalkori Zelboraf Kadcyla Perjeta Adcetris Xeloda Afinitor, Faslodex Iressa, Revlimid Avastin Alimta) • Branded Oncology Therapeutics Market Share 2014-2021 (Herceptin Erbitux Gleevec Tarceva Kadcyla Perjeta Xeloda Afinitor Revlimid Avastin Alimta) • Top Pharma Companies Revenue from Targeted Therapeutics in Oncology (Roche, Novartis, Janssen, BMS, AstraZeneca, Sanofi, GSK, Pfizer, Amgen, Eli Lilly) • Branded Cardiovascular Targeted Therapeutic Total Market 2014-2021 • Branded Cardiovascular Targeted Therapeutics Market Forecast by Drug 2014-2021 (Metoprolol, Bidil, Plavix, Carvedilol) • Infectious Disease Targeted Therapeutics Market to 2014 - 2021 • Branded Infectious Disease Targeted Therapeutics Market by Drug 2014-2021 (Incivek, Pegasys, Selzentry, Ziagen, Sovaldi, Harvoni) Similarly, data for the companion diagnostic section is given. Personalized Medicine Targeted Therapeutics – Oncology In order to get an in depth understanding of the oncology therapeutics section within the personalized medicine market it is important to initially review the global oncology therapeutics market. Oncology continues to be an area of high unmet need and product revenue potential. Oncology is the largest global therapeutic area, with global sales of $x billion in 2016; that is anticipated to reach $x billion by 2021. Increasing cancer prevalence globally is a major driver of the market, and this is further underlined by more sensitive diagnostics and screening methods. The predicted revenue growth in the oncology space is reinforced by increasing cancer prevalence, as well as advances in diagnosis methods and screening programs. The current trend is that patients are advancing to 2nd, 3rd and 4th line therapy regimes, and so this progression further expands the market. A significant driver of revenue growth is the cost of oncology therapeutics and biologics. For example, Yervoy (BMS) annual costs are $x for four doses. Another example is Dendreon's Provenge which has an annual cost of $x for three doses. This significant increase in the price of oncology therapeutics has expanded the market, even though price reductions have been fought for by payers. Targeted Cancer Therapeutics Targeted cancer therapeutic sales have significantly risen in the recent past with a x% increase from 2013 to 2014 alone. The global oncology market is currently booming and one of the main reasons for this increase is the dramatic rise in the number of prescribed targeted therapies. The market is also growing in size as the cost of targeted therapeutics is high. This is due to longer treatment times, increased investment and development costs. Targeted therapeutics also are, by definition, designed to treat smaller cohorts of patients, albeit more effectively. Therefore, pharmaco's need to recoup costs via pricing. Two major targeted therapeutics on the market are Roche's melanoma agent Zelboraf and Pfizer's lung cancer agent Xalkori. Zelboraf (vemurafenib) is a MEK inhibitor indicated for skin cancer and in FY2013 reached $x million. Xalkori (crizotinib) is indicated in patients positive for an ALK mutation and has an annual sale figure of €x million. Top Ten Companies in Oncology Drug Sales Roche Holdings continues to occupy its first position in oncology market. The company's sales performance was driven by HER 2-positive breast cancer therapies. Globally, it is the largest maker of cancer treatments and mainly focuses on biologic drugs. Most of its cancer drugs are developed by California-based Genentech, a pioneer in biologic therapies that Roche acquired in 2009. Worldwide sales of Herceptin, that is about to lose patent protection year, rose 9%. But sales of Perjeta and Kadcyla, two follow-on therapies, increased by triple-digit percentages, drawing attention to the company's success in developing successor products. Roche is pinning its hopes on follow-on products to preserve its place in the market once generic competition, known as biosimilars, begin to appear. These biologic therapies usually have higher margins than conventional drugs and are more difficult to copy. Bristol-Myers Squibb's overall sales rose by about x% only, but its cancer immunotherapy drugs witnessed huge sales gains. Its Yervoy, a skin-cancer immunotherapy, leaped x% to $x million in the fourth quarter, while Opdivo, another skin-cancer drug approved in late December 2014, contributed sales of $x million. The company's sales of leukemia drug Sprycel rose x% to $x million in 2016. Celgene Corporation has reported that its revenue rose in the most recent period, driven by sales growth of its key cancer treatment, particularly in the U.S. The company expects 2015 to be an important year for Revlimid, a blockbuster blood-cancer drug, which will be tested in trials for treatment of a kind of lymphoma. The FDA is expected to decide whether the drug can be used to treat newly diagnosed multiple myeloma. Regulatory bodies in the U.S. and the E.U. are making key decisions on the drug. Revlimid sales increased x% to $x billion in the most recent quarter, as market share expanded along with the duration of therapy. U.S. sales of the drug grew by x% while international sales increased x%. The personalized medicine, targeted therapeutic and associated companion diagnostic market have huge opportunities for growth. This industry will revolutionize the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics. Companies Mentioned • 23andMe • Abbott Laboratories • Abbott Molecular Inc. • Admera Health (GENEWIZ) • Affymetrix • Agendia • Alere • Amgen • Astex Pharmaceuticals • AstraZeneca • Atossa Genetics • Becton Dickenson • bioMerieux • BristolMyersSquibb • Cancer Genetics • Celera (Quest Diagnostics) • Celldex Therapeutics • Claritas Genomics • CuraGen • Danaher (Leica Biosystems) • deCode Genetics (Amgen) • Foundation Medicine • EDP Biotech • Eli Lilly • ELDA BioTech • Eisai • Genelex • GlaxoSmithKline • Human Longevity Inc (Cypher Genomics) • HalioDx • Ikonisys • Illumina • InterGenetics • Johnson & Johnson • LabCorp • Life Technologies • Merck • MDxHealth • MolecularMD Corporation • Monogram Biosciences • Myriad • Nodality • Novartis MDx • Orion Genomics • Oxford BioTherapeutics • NanoString Technologies • Pfizer • Qiagen • Roche Molecular Diagnostics • Sanofi • SensiGen • Siemens Healthcare Diagnostics • Takeda • Thermo Fisher Scientific • Transgenomic • Ventana (Roche) • Vermillion (Ciphergen) • Vertex Pharmaceuticals Read the full report: http://www.reportlinker.com/p03118741/Personalized-Medicine-Targeted-Therapeutics-and-Companion-Diagnostic-Market-to-Strategic-Analysis-of-Industry-Trends-Technologies-Participants-and-Environment.html About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/personalized-medicine-targeted-therapeutics-and-companion-diagnostic-market-to-2021--strategic-analysis-of-industry-trends-technologies-participants-and-environment-300456319.html


The invention provides a method for determining whether a human immunodeficiency virus is likely to be more resistant to a viral entry inhibitor than a reference HIV. In certain aspects, the methods comprise comparing the length of one or more variable regions of an envelope protein of the HIV or a number of glycosylation sites on the envelope protein of the HIV to a length of one or more corresponding variable regions of an envelope protein of the reference HIV or a number of glycosylation sites on the envelope protein of the reference HIV, wherein the HIV is likely to be more resistant to the CD4 binding site entry inhibitor than the reference HIV when the HIV has longer variable regions than the reference HIV or the HIV has more glycosylation sites than the reference HIV.


Patent
International Aids Vaccine Initiative, Monogram Biosciences, Caulfield, Hoffenberg, King Fahd University of Petroleum, Minerals, Petropoulos, Phogat, Wagner and Wrin | Date: 2015-03-18

The present application relates to identifying one or more components of HIV envelope glycoprotein which bind to broadly neutralizing antibodies, which may be utilized as research tools for developing HIV-1 vaccine immunogens, antigens for crystallization and/or for identifying of broad neutralizing antibodies.


The invention provides a method for determining whether a human immunodeficiency virus is resistance to a viral entry inhibitor. The methods are particularly useful for determining resistance to inhibitors that act by a non-competitive mechanism. In certain aspects, the methods comprise determining whether an HIV population is resistant to an HIV entry inhibitor, comprising determining a log-sigmoid inhibition curve comprising data points for entry of the HIV population in the presence of varying concentrations of the HIV entry inhibitor, wherein if the entry of the HIV population cannot be completely inhibited by the HIV entry inhibitor, the HIV population is resistant to the HIV entry inhibitor.


Patent
Monogram Biosciences | Date: 2015-08-14

Methods, compositions and kits are disclosed for determining one or more target polypeptides in a sample where the target polypeptides have undergone a post-translational modification. A mixture comprising the sample and a first reagent comprising a cleavage-inducing moiety and a first binding agent for a binding site on a target polypeptide is subjected to conditions under which binding of respective binding moieties occurs. The binding site is the result of post-translational modification activity involving the target polypeptide. The method may be employed to determine the target polypeptide itself. In another embodiment the presence and/or amount of the target polypeptide is related to the presence and/or amount and/or activity of an agent such as an enzyme involved in the post-translational modification of the target polypeptide. The interaction between the first binding agent and the binding site brings the cleavage-inducing moiety into close proximity to a cleavable moiety, which is associated with the polypeptide and is susceptible to cleavage only when in proximity to the cleavage-inducing moiety. In this way, an electrophoretic tag for each of the polypeptides may be released. Released electrophoretic tags are separated and the presence and/or amount of the target polypeptides are determined based on the corresponding electrophoretic tags.


This invention relates to methods for determining hypersusceptibility of HIV-1 viruses to non-nucleoside reverse transcriptase inhibitors (NNRTIs) based on the viral genotypes. The methods generally comprise detecting, in a gene encoding reverse transcriptase of the HIV-1, the presence of a mutation at codon 65, 69, or 74 alone or in combination with one or more mutations at certain other codons. Combinations of mutations associated with hypersusceptibility to NNRTIs are also disclosed.


This invention relates to methods for determining resistance of HIV-1 viruses to protease inhibitors (PIs) based on the viral genotypes. The methods generally comprise detecting, in a gene encoding protease of the HIV-1, the presence of a mutation in at least one of codon 22, 69, 74, or 83 alone or in combination with one or more mutations at certain other codons, or, in a gene encoding gag of the HIV-1, the presence of a mutation in at least one of codon 418 or 482 alone or in combination with one or more mutations at certain other codons. Combinations of mutations associated with resistance to PIs are also disclosed.


Patent
Monogram Biosciences | Date: 2014-12-03

The present invention provides a method for identifying whether a compound inhibits entry of a virus into a cell which comprises: (a) obtaining nucleic acid encoding a viral envelope protein from a patient infected by the virus; (b) co-transfecting into a first cell (i) the nucleic acid of step (a), and (ii) a viral expression vector which lacks a nucleic acid encoding an envelope protein, and which comprises an indicator nucleic acid which produces a detectable signal, such that the first cell produces viral particles comprising the envelope protein encoded by the nucleic acid obtained from the patient; (c) contacting the viral particles produced in step (b) with a second cell in the presence of the compound, wherein the second cell expresses a cell surface receptor to which the virus binds; (d) measuring the amount of signal produced by the second cell in order to determine the infectivity of the viral particles; and (e) comparing the amount of signal measured in step (d) with the amount of signal produced in the absence of the compound, wherein a reduced amount of signal measured in the presence of the compound indicates that the compound inhibits entry of the virus into the second cell.


Provided are methods for identifying whether a compound inhibits entry of a virus into a cell. The method may include obtaining nucleic acid encoding a viral envelope protein from a patient infected by the virus and co-transfecting it into a first cell along with a viral expression vector which lacks a nucleic acid encoding the envelope protein. The method may further include contacting the viral particles produced by the first cell with a second cell to which the virus binds in the absence and presence of the compound and measuring the amount of signal produced by the second cell.

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