Lateral Flow Test Development

Case Study

Improving Patient Safety: Verax Biomedical partners with BBI to develop challenging assay requiring FDA clearance

The Challenge

Verax Biomedical was founded upon a single vision – to improve patient safety by detecting bacterial contamination in blood components, cells and tissues prior to transfusion and transplantation.

The company set out to ‘fill the hole’ in blood safety by launching a world first rapid test for the detection of bacterial contamination in platelets.

A challenging assay requiring FDA clearance, the company needed an experienced partner who could deliver a robust and stable platform along with the manufacturing capability to scale up to meet demand.

BBI deliver exceptional products and technologies that people rely on to enjoy a better quality of life

The Solution

Lateral flow was identified as the right platform to deliver the rapid results in both high and low volume environments. While Verax had its own R&D team capable of developing and processing the required antibodies in-house, the company sought a partner with the level of conjugation experience necessary to deliver the required stability.

Chief Executive Officer (CEO) James Lousararian explained “In a bio-chemical platform, stability and consistency is crucial. When added to the multi-target complexity of our assay, this put an enormous premium on having a partner experienced in making stable and consistent conjugate.”

On the selection of BBI Solutions, James commented “The gold and conjugation processes at BBI are unrivaled – we found that BBI was the best that we could work with.”

While BBI was initially selected for its gold and conjugate supply, the relationship quickly expanded to full development and a long term manufacturing partnership.

Developing a Pan Genera® Detection (PGD®) assay is very complex, especially when trying to rapidly detect all the likely types of bacteria that have been found in blood components. Based on BBI’s excellent reputation for developing hundreds of assays under regulated conditions and FDA design control, Verax decided to partner with BBI to develop this challenging assay.

With 6 million platelet transfusions performed annually worldwide, BBI was also able to offer Verax the ability to scale up when required through its FDA registered manufacturing facility.

What started as a component supply and service relationship quickly blossomed into a collaborative development process and a real partnership

Results & Benefits

The project was a success! By partnering with BBI, Verax met its objectives, delivering a world first product that has proven to be remarkably effective and consistent in the field.

The demonstrated effectiveness of the product led the US FDA to clear Verax to label the Platelet PGD Test as a safety measure for single donor platelets, instead of merely a process or manufacturing quality control or QC test.

The only FDA cleared safety measure for this application; the Verax Platelet PGD Test is used in hospitals and blood banks throughout the USA, Europe and Middle East.

Verax and BBI are partnering again to develop a next generation assay that will allow expansion into new territories and further improve usability and performance.

Want to learn more?

Contact us to find out how we can help you develop your next generation assay.

The BBI team took a very complicated problem and delivered an assay that is very simple to use and easy to interpret – successfully adapting the technology to the application

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