Seattle, WA. February 21, 2014 – Pacific Biomarkers announces the expansion of its services portfolio to include ultra-sensitive biomarker assays using the Singulex® Erenna® Immunoassay technology. Based on an innovative single-molecule counting technology (SMCT), these services are designed to provide sub-picogram sensitivity for analytes in a variety of matrices. The detection methodology extends the dynamic range to over 4 logarithms, allowing a wide range of biomarker measurement and hence minimal need for repeats.
For pharmacokinetic (PK) and/or pharmacodynamic (PD) studies, the Singulex® high-definition immunoassay can accelerate pre clinical and clinical research. Singulex uses the patented Erenna® Immunoassay System, a blend of known technology using innovative digital technology to measure single molecules at femtogram per mL concentrations.
Of further utility is measurement of PK where the traditional methodologies of ELISA or ECL have offered a limited resolution as well as sensitivity that has often been unable to show a full profile of some drugs, especially for the large biopharmaceuticals.
Older methodologies have had a limited ability to measure the ultra low concentrations of these compounds especially when used either in dose-escalation studies or in micro-dosing studies. A Singulex® immunoassay allows for the detection of lower levels of a drug to provide a more complete kinetic profile, as well as allowing for the identification of clearance patterns undetectable by traditional immunoassay methodologies.
Assay development can be a simple and as efficient as any ELISA or MSD development. If the antibody can be labeled then it can be run on the Erenna® platform. Additionally the assay can be run with magnetic beads to further enhance the Lower Limit of Quantitation (LLOQ) to levels similar to that seen with LC-MS or MS-MS assays. This additional step is as simple as a regular conjugation and adding greater sensitivity with uncompromising reduced matrix interference, especially important if the latter is an issue in pre-clinical studies.
“We are pleased to expand our portfolio to include ultra-sensitive cytokine detection services to our customers,” said Amar A. Sethi, MD, PhD, Chief Scientific Officer at Pacific Biomarkers. “We now have the unique ability to measure basal levels of cytokines and other biomarkers in the femtogram per ml range.”
Ultra-sensitive cytokine detection services demonstrate PBI’s commitment of providing pioneering services to its customers. These services complement cytokine, protein multiplex, ELISA and cell based assay services performed under GLP, CAP/CLIA standards.
For additional information about this technology, please visit our website: www.pacbio.com.
Pacific Biomarkers is a premier biomarker laboratory services provider in the Drug Development Industry supporting preclinical and Phase I-IV studies. Since 1989, Pacific Biomarkers has partnered with the Pharmaceutical, Biotech and Diagnostic Manufacturing Industries to provide biomarker laboratory services. Due to these partnerships and our ability to adapt biomarkers to support compound development we have optimized study outcomes, decreased sponsors’ timelines for FDA approval, and provided competitive product differentiation.