August 27, 2016 9:37 PM ET

Biotechnology

Company Overview of Monogram Biosciences, Inc.

Company Overview

Monogram Biosciences, Inc. develops and commercializes diagnostic products for the treatment of human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection, and other viral illnesses, as well as cancer and other diseases. It offers HIV tests, including genotypic, phenotypic, tropism, and combined phenotype/genotype assays, as well as suppression management and viral load testing; HCV assays; and oncology tests. The company also provides biopharmaceutical partners and research collaborators with clinical, scientific, and logistical support for critical drug development projects in HIV infection, HCV infection, and oncology via agreements, strategic alliances, and long term...

345 Oyster Point Boulevard

South San Francisco, CA 94080-1913

United States

Founded in 1995

382 Employees

Phone:

650-635-1100

Fax:

650-635-1111

Key Executives for Monogram Biosciences, Inc.

Chief Executive Officer, President, Secretary and Director
Age: 56
Vice President of Operations
Age: 55
Chief Scientific Officer and Vice President of Research & Development - Virology
Age: 62
Executive Vice President, Treasurer and Director
Age: 50
Vice President of Human Resources
Age: 59
Compensation as of Fiscal Year 2016.

Monogram Biosciences, Inc. Key Developments

Monogram Biosciences, Inc. Presents Two New Studies Characterizing HIV-1 and HCV Antiviral Drug Resistance

Monogram Biosciences Inc. presented two new studies characterizing HIV-1 and HCV antiviral drug resistance. In a study entitled Dolutegravir Resistance Requires Multiple Primary Mutations in HIV-1 Integrase, Monogram investigators demonstrate that resistance to dolutegravir, the newest member of the HIV-1 integrase inhibitor drug class, requires combinations of mutations known to confer resistance to this drug class. Using Monogram's proprietary PhenoSense HIV drug resistance platform, the investigators associate quantitative reductions in dolutegravir sensitivity with specific combinations of mutations that confer integrase inhibitor resistance. This finding supports the favorable response rates observed in patient populations treated with regimens that incorporate dolutegravir following prior treatment failure with an integrase inhibitor-containing regimen. In a study entitled Characterization of Naturally Occurring Resistance to HCV NS5A Inhibitors, Monogram investigators study the viruses of treatment naive individuals infected with HCV genotype 1 (GT1) for the presence of mutations that are associated with NS5A inhibitor resistance. Using Monogram's proprietary HCV GenoSure NS5A Assay and a sensitive next generation sequencing approach, the investigators are able to detect pre-existing resistant variants within patient virus populations belonging to the two major HCV subtypes (GT1a and GT1b) that circulate in the US Naturally occurring NS5A resistance mutations are more varied among GT1a viruses compared to GT1b viruses. GT1a viruses are also more to contain more than one NS5A inhibitor resistance mutation. In addition, the investigators demonstrate that the size of the subpopulations of resistant variants within GT1a viruses is larger compared to GT1b viruses. Finally, using Monogram's proprietary PhenoSense HCV drug resistance assay, the investigators demonstrate that NS5A mutations confer larger reductions in NS5A inhibitor susceptibility in the context of GT1a sequences compared to GT1b sequences. Overall, these observations suggest that GT1a viruses may be more prone to naturally-occurring and acquired NS5A inhibitor resistance than GT1b viruses.

Laboratory Corporation of America(R) Holdings and Monogram Biosciences, Inc. Introduces HIV-1 Next Generation Sequencing Assay to Support Drug Regimen Changes in HIV Suppressed Patients

Laboratory Corporation of America(R) Holdings and Monogram Biosciences Inc. announced the launch of HIV GenoSure Archive, the first laboratory test to help optimize antiretroviral (ARV) drug regimens in virally suppressed HIV patients. GenoSure Archive was developed using the Next Generation Sequencing (NGS) platform. Advances in HIV drug therapy have allowed patients to achieve and maintain complete suppression of viral replication. Life-long treatment, however, is necessary to maintain viral suppression. Such treatment therapies often have adverse side effects, and as new, more simplified ARV drug regimens become available, patients may benefit from new therapies. Previous laboratory testing to guide ARV drug selection required higher viral loads than what many patients have, leaving clinicians without a reliable diagnostic tool to guide ongoing therapy choices. HIV GenoSure Archive is the first genotypic drug resistance assay specifically designed to reliably identify the HIV DNA compartment, and it provides physicians and other HIV care providers with critical diagnostic information to support individualized and updated therapies for patients with low or undetectable viral loads of HIV-1. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole-blood samples and then analyzing the polymerase (pol) region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely utilized ARV drug classes. GenoSure Archive evaluates the full-length protease and integrase coding regions and amino acids 1 to 400 of the HIV-1 reverse transcriptase region. Resistance interpretations leverage Monogram's database of over 150,000 matched phenotype and genotype test results. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole-blood samples and then analyzing the polymerase (pol) region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely utilized ARV drug classes. GenoSure Archive evaluates the full-length protease and integrase coding regions and amino acids 1 to 400 of the HIV-1 reverse transcriptase region. Resistance interpretations leverage Monogram's database of over 150,000 matched phenotype and genotype test results.

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