Founded in the late 1990s, Agilex Biolabs was established to fill a critical need in Australia for high-quality bioanalytical support in clinical research. Starting as a modest analytical laboratory in Adelaide, the company rapidly gained recognition for its scientific expertise and regulatory compliance.

From its early days, Agilex invested heavily in liquid chromatography–mass spectrometry (LC-MS/MS) technologies. This foundational commitment to advanced instrumentation set the stage for its emergence as a premier provider of bioanalytical services across therapeutic areas, including oncology, neurology, infectious disease, and metabolic disorders.

As the demand for biologics and targeted therapies grew, Agilex expanded into ligand-binding assays and immunoassays. The laboratory adopted new technologies including ELISA, MSD, Gyrolab, and more recently, high-sensitivity platforms like Simoa to meet the increasingly complex demands of biopharma R&D.

In 2021, Agilex Biolabs strategically expanded its offerings to include GLP-compliant toxicology services through the acquisition of TetraQ, a leader in Australian preclinical safety testing. This move allowed Agilex to offer end-to-end support across the drug development continuum—from early toxicology through clinical bioanalysis.

The toxicology division provides comprehensive services including:

• Preclinical PK studies
• Acute, subchronic, and chronic GLP toxicology studies
• Carcinogenicity

Through our Global Partners

• Large animal GLP toxicology studies
• Histopathology and clinical pathology
• Regulatory consulting and study design support

This addition has allowed Agilex to integrate nonclinical and clinical data generation under one roof, delivering time-saving and cost-efficient benefits to clients navigating regulatory pathways worldwide.