Off-the-Shelf, Pre-validated Assays for Your Bioanalysis Projects from Crux Biolabs

By Anita Yusim

As you undertake bioanalytical testing, having reliable and validated assays is essential to ensuring that your data is accurate, reproducible, and regulatory-compliant. That’s why Crux Biolabs offers a range of off-the-shelf, pre-verified/pre-validated assays that can significantly streamline your project timeline while maintaining the highest standards of accuracy and precision.

Why Are Validated Assays So Important?

When conducting bioanalytical assays – particularly in the early phases – the data you generate needs to be reliable. Generally, regulatory authorities like the FDA, EMA, and TGA require that bioanalytical tests be performed using validated techniques. Validation ensures that your assays are robust, precise, and accurate — three critical factors when testing clinical samples.

1. Robustness means that the assay delivers consistent results across different conditions—whether tested by different analysts, on different days or with different equipment.
2. Precision ensures that repeated tests yield the same results, even when conducted by different operators.
3. Relative Accuracy and parallelism guarantees similarity of reference materials to endogenous analytes and is crucial to detect potential matrix effects.

In addition, we validate critical factors like freeze-thaw stability and long-term stability to ensure that your samples can be stored and retested without compromising data integrity. We also account for variations in matrices—for example, an assay validated for serum might need further testing for its use in other biological matrices like saliva or nasal samples.

How Pre-Validated Assays Can Save You Time and Money

Crux Biolabs is dedicated to supporting your clinical trial goals, and we recognise that the validation process can be time-consuming and costly. That’s why we’ve gone the extra mile by pre-validating a selection of assays in-house. By offering these pre-validated assays – or off-the-shelf assays – we provide clients with immediate access to assays that can be directly applied to their studies, without the usual lead time involved with custom qualification.

For many common biomarkers, our pre-validated panels are available for immediate use, allowing you to accelerate into testing clinical samples faster. Instead of starting from scratch, you benefit from a ready-to-go solution that has already undergone rigorous validation by our team. This not only saves you time but also reduces your costs by eliminating the need for study-specific validation.

The Crux Biolabs Advantage: Expertise in Both Off-the-Shelf and Custom Assays

While pre-validated assays offer significant advantages, there are times when your program may require a more tailored solution. Crux Biolabs is equipped to handle both off-the-shelf assays and custom assay development, ensuring that we can meet your unique needs.

For instance, we regularly work with clients who require custom validations — tailoring specific parameters to meet their study’s requirements. This is particularly common when you need to test beyond the standard conditions, such as validating assays for specialised sample matrices or assessing specific stability conditions.

Moreover, we specialise in developing custom assays in-house for unique applications, such as pharmacokinetic (PK) assays to track the concentration of a drug in the body over time. These assays are essential for understanding how a drug behaves in clinical settings, helping to identify key pharmacological properties and support drug approval processes.

A Real-World Example: Saving Time and Money with Pre-Validated Panels

In practice, the benefits of using pre-validated assays can be substantial. For example, one client came to Crux Biolabs with a need to use our MSD pro-inflammatory panel for a clinical trial. While they were interested in using this assay, the matrix they were testing was not initially covered by our standard pre-validation. Instead of starting an entirely new validation process, we leveraged the existing pre-validated package and conducted a few additional validation runs to confirm the assay’s applicability to the new matrix.

This approach allowed us to significantly reduce the lead time for the project. Instead of the client waiting several weeks for a full custom validation, we were able to provide results in a fraction of the time, saving them at least a month of work. The client received a fully validated assay report in record time, which helped them move forward with their clinical trial on schedule.

Who Can Benefit from Pre-Validated Assays?

Typically, clients who are in the early stages of clinical trials, particularly those entering Phase 1 of drug development, will benefit most from pre-validated assays.

Why Choose Crux Biolabs?

At Crux Biolabs, we partner with you to ensure your data is robust and your project stays on track. Our team of experienced scientists can help you navigate the complexities of assay validation, whether you need an off-the-shelf solution or a completely custom-developed assay.

Our commitment to scientific excellence ensures you are provided with the tools and expertise to advance your drug development program efficiently and successfully.

By choosing Crux Biolabs, you can be confident that your bioanalytical needs are in capable hands. Whether you’re looking for pre-validated assays or a custom solution, we offer a comprehensive range of services to support your clinical trials every step of the way.