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Validated bioassays
(off-the-shelf)
Pre-validated methods ready for immediate deployment to accelerate your rare disease drug development program.
A shared-cost model for accelerated deployment
Regulatory expectations for primary biomarker outcomes require rigorous method validation. AGADA Biosciences relies on a shared-cost model to provide pre-validated bioassays for Duchenne and Becker muscular dystrophies. By absorbing the initial regulatory effort, our approach instantly shifts your biomarker program from development to deployment, avoiding months of setup time.
FDA-reviewed and regulatory-compliant tests
Our senior scientists ensure that every method aligns with the specific context of use for your trial to generate defensible data.
Western blot
We utilize highly sensitive methods to detect dystrophin levels as low as 0.25% to capture subtle therapeutic signals.
Immunofluorescence
We accurately map dystrophin localization and intensity across your tissue samples.
Luciferase immunoprecipitation system
We detect treatment-emergent dystrophin antibodies in serum and plasma samples to support your efficacy studies.
Discuss your bioassay strategy
Engage our experts to deploy pre-validated bioassays for your rare disease program.
Deep specialization in rare disease research
AGADA Biosciences applies focused expertise where it matters most.
We understand the unique challenges of your rare disease program and deliver data that accelerates progress.
Validation cost savings:
Our shared-cost model saves individual pharmaceutical companies between $400,000 and $600,000 in internal validation costs.
Accelerated deployment:
Utilizing our existing methods cuts two to four months from standard setup schedules.
Historical benchmarking:
We leverage vast archival data from over 100 trials in mouse models of muscular dystrophy.
Submission readiness:
We ensure your research translates into data that regulators clearly trust.
Predictable schedules for clinical sample testing
Bypassing the validation phase lets you proceed directly to clinical sample testing, keeping your program on schedule.
Built to integrate
AGADA Biosciences acts as a collaborative partner, integrating smoothly into your existing vendor ecosystem.
We share access to secure data portals to ensure fast transfer of results for our sponsors.
Direct access to senior experts
Our lean scale keeps scientific expertise close to the work, so decisions are made in minutes rather than weeks.
Fit-for-purpose alignment:
We align your bioassays with rigorous FDA expectations for primary trial outcomes.
Flexible integration:
We generate customised protocols for central laboratories to securely send samples.
Clear accountability:
We manage specialized workflows without demanding total control of your trial.
Continuous oversight:
Senior researchers actively monitor assay performance to protect data integrity.
Start a conversation
Reach out to our team to ensure your clinical data is strictly fit for purpose and ready for submission.
Where history meets innovation
In the heart of downtown Halifax, AGADA has transformed a historic building into a modern facility dedicated to advancing rare disease therapeutics. Take a closer look at our laboratories, scientific capabilities and dedicated team and discover how our unique location and collaborative environment support the work we do for clients and patients worldwide.
Quality and compliance
We operate in strict compliance with GCP, GLP and GDPR regulations to ensure your data remains interpretable and defensible. Every team member must hold a CITI certification before supporting any sponsor trial.
Meet our scientific leadership
Our founders and senior scientists are globally recognized leaders in rare and neuromuscular disease research, bringing decades of specialized expertise to your program.
News and resources
AGADA Biosciences provides pre-validated, off-the-shelf bioassays to save sponsors months of setup time and hundreds of thousands of dollars in validation costs.
