How Adaptive Problem-Solving Transformed a Veterinary Diagnostic Breakthrough:
Carus Animal Health aimed to develop a point-of-care lateral flow test to measure faecal calprotectin in dogs and cats. While measurement of faecal calprotectin is well established in human medicine, there was no equivalent test available for use in veterinary practice, leaving veterinarians without a reliable rapid diagnostic tool for assessing gastrointestinal (GI) inflammation in companion animals.
Carus Animal Health contracted Abingdon Health for comprehensive CDMO solutions. This partnership involves full-service contract development services, including regulatory support, to develop, optimise, validate, and scale routine manufacturing processes for an innovative diagnostic product, furthering their commitment to animal health.
From the outset, the objective was to create a quantitative lateral flow assay capable of providing a meaningful assessment of faecal calprotectin concentrations in companion animals, enabling earlier, more accurate diagnosis of gastrointestinal disorders. A further goal was to pair the assay with a smartphone app able to capture an image of the completed test, analyse band intensity and deliver a numerical result. This quantitative functionality was intended to support clinicians in assessing gradations in gastrointestinal inflammation and in monitoring changes over time, including response to therapeutic intervention.
Challenges
The lateral flow development progressed well. However, it was decided that the app was not going to add any additional benefit at the early stage of commercial launch and the need for this would be re-evaluated at a later stage following 6 months marketing.
Solution
Abingdon's team quickly identified and proposed an alternative semi-quantitative scorecard their team had been evaluating. The scorecard featured 10 incremental band intensities that would enable users to visually score severity without requiring an app. The scorecard could be used at the point of care, providing a semi-quantitative result immediately while eliminating the need for costly digital infrastructure. The scorecard was tested with a set of clinical samples comprising both IBD cases and healthy controls and these were compared against the results of the same tests read by a commercially available dedicated LFT reader provided by Abingdon.
Results & Impact
Testing showed that the 10-point scorecard performed as effectively as the quantitative LFT reader. It reliably discriminated between dogs with normal gastrointestinal (GI) tracts and those with inflamed GI tissue. The scorecard system also enabled the monitoring of response to treatment. This semi-quantitative solution enabled a fast readout at the point of care.
The subsequent launch was highly successful. The scorecard was well received by clinicians, many of whom appreciated its simplicity, speed, and practicality. The scorecard may represent a superior outcome compared with a more costly app-based quantification that would require additional digital infrastructure and support. The scorecard's simplicity and lower price point accelerated speed to market and adoption demonstrating the commercial value of Abingdon's Design For User expertise.
Steve Long, Operations Director had this to say: “Abingdon Health’s proactive problem-solving added significant value at a critical point in the project. By providing a robust, point-of-care solution, Abingdon ensured we could still deliver a test with a semi-quantitative readout that clinicians found both intuitive and reliable. Their intervention helped to protect the project timeline and provided a significant reduction in cost of goods by eliminating the need for a smartphone app and associated infrastructure.”
Why did you choose Abingdon Health?
Abingdon offered a comprehensive suite of services capable of advancing a diagnostic concept through to full launch readiness.
Find out more about GIQuest and our partnership with Carus Animal Health here.
