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The announcement was made at BioPharm America (September 21-24, 2020).
The assay is already being used by 4 sponsors in drug development.
Agilex Biolabs CEO Jason Valentine said the company was now very much at the forefront of assay development for cannabis clinical trials, with more assays in the pipeline.
"We have developed a high sensitivity, quantitative assay for the detection of CBN, CBD and THC and metabolites in human plasma.
The Agilex Biolabs cannabinoids assay achieves >98% of ISR (Incurred Sample Reanalysis) samples within the acceptance criteria, which demonstrates that it is robust and reproducible.
The FDA and EMA criteria is 67% of samples within 20%.
This is the best-in-class because we have resolved interferences that over-state THC concentrations that can potentially skew reported data. The improved accuracy and sensitivity means we now have a precise low level assay for our clients.
This competes with anything in the world for accuracy, and cuts the risk of flawed results.
Due to high client demand a CBD and metabolites assay is in development and will be ready before end of the year."
Agilex is also now offering additional pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
- Receptor occupancy
- Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
- PBMC assays and cellular mechanism of action assays (eg: ADCC)
Agilex Biolabs, the only FDA-inspected lab of its type in the Asia-Pacific, offers bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the two platforms of LC-MS/MS and Immunoassay (MesoScale, Gyrolab).
The FDA-inspected facilities have more than 90 dedicated laboratory staff, and annually support more than 80 clinical trials. This year Agilex Biolabs will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC.
By combining specialised expertise, technological innovation and a 20-year track record, Agilex Biolabs have supported hundreds of preclinical and clinical trials around the world.
Agilex Biolabs' world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.