Commercial assay for Tysabri (Natalizumab) developed to enable physicians to make data driven decisions on how to optimize the infusion schedule for their multiple sclerosis patients.
SAN DIEGO, Calif. (PRWEB) August 30, 2018 — Abreos Biosciences, a leader in the precision dosing of biological therapeutics, is pleased to announce a collaboration with ResearchDx, a recognized leader in the design, development, implementation and regulatory approval of next generation companion diagnostic products. Together with ResearchDx, Abreos has developed moNATor, its first commercial product for therapeutic drug monitoring of Tysabri (Natalizumab). The moNATor assay will be available to clinicians and clinical trial partners though Pacific Diagnostics (PacificDx) — ResearchDx’s CLIA approved, College of American Pathology accredited, and GxP compliant reference laboratory.
“We are excited to launch the moNATor assay for the monitoring of therapeutic levels of Tysabri (Natalizumab)” said Shelly Gunn MD, PhD. ResearchDx’s Chief Medical Officer and Medical Director of the PacificDx clinical laboratory. “The moNATor assay represents a new, highly sensitive class of assays designed to monitor levels of active drugs in the blood. We are the first laboratory to offer this new technology and are looking forward to the future validation of additional drug monitoring applications of Abreos’ patented Veritope technology.”
Natalizumab (marketed name Tysabri®) is a humanized anti-α4 integrin monoclonal antibody used in the treatment of relapsing-remitting Multiple Sclerosis and Crohn’s Disease. Prolonged therapy together with other risk factors (like active JCV infection) have been associated with increased risk of Progressive Multifocal Leukoencephalopathy (PML). The moNATor assay enables physicians to monitor the levels of active Natalizumab throughout the therapy to ensure patients are on the right infusion schedule, helping to prevent excessive costs and reduce risk factors.
About Abreos Biosciences:
Abreos Biosciences, a San Diego-based biotech company was founded in 2013 by CEO Dr. Bradley Messmer and is focused on developing technologies in precision medicine using their proprietary Veritope platform. By simply monitoring biologics in blood, Abreos has developed a portfolio of applications built with the patient in mind to ensure that patients are on the right therapies at the right dose. Point-of-care devices are also available for clinical testing.
About ResearchDx, Inc (Pacific Diagnostics):
ResearchDx, a California based Companion Diagnostics Organization (CDO) was founded in 2008 by Drs. Philip Cotter and Mathew Moore. ResearchDx is a “full service” Contract Diagnostics Organization dedicated to the design, development, manufacture and commercialization of diagnostic testing for the clinical, clinical research and biopharmaceutical industries. All diagnostic testing services are supported by Pacific Diagnostics (PacificDx), ResearchDx’s CLIA approved, College of American Pathology accredited, and GxP compliant reference laboratory.
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