UK based lateral-flow test specialists, Lateral Dx, have partnered with Dr Christopher Thornton of ISCA Diagnostics to tackle the rapidly emerging pathogen of Mucormycosis, providing a rapid point-of-care diagnostic test solution.
Mucormycosis (or ‘black fungus’ disease) is a highly aggressive fungal infection of humans caused by a group of molds known as the Mucorales, with the principal agent of disease being Rhizopus arrhizus. It is the main cause of life-threatening infections in patients with poorly-controlled diabetes mellitus, in COVID-19 patients treated with corticosteroids to dampen lung inflammation, and in immunocompromised individuals whose damaged immune systems make them particularly vulnerable to fungal infections.
Mucormycosis has seen a dramatic increase in the number of cases since the beginning of the COVID-19 pandemic and is of increasing concern globally, especially in developing countries. Symptoms vary depending on where the disease is in the body, from the sinuses, brain, lungs, skin or stomach. It is a curable disease only when diagnosis is made at the start of infection, and where surgery and treatment with antifungal drugs is used at an early stage.
The current diagnostic process is insensitive, slow and non-specific, performed using a biopsy and culture along with imaging to determine the extent of the disease. This is both costly and time consuming for our healthcare providers and an invasive procedure for patients, often delaying crucial and lifesaving treatment.
ISCA Diagnostics approached Lateral Dx with an in-house developed monoclonal antibody (KC9) and diagnostic biomarker to partner on the development of a competitive lateral flow test for Mucormycosis. ISCA specialises in the development of highly specific mAbs and biomarkers for pathogenic fungi, and Lateral Dx are leaders in the development of lateral-flow tests. In a recent article published in the Journal of Fungi entitled “Development of a Monoclonal Antibody and a Serodiagnostic Lateral-Flow Device Specific to Rhizopus arrhizus (Syn. R. oryzae), the Principal Global Agent of Mucormycosis in Humans” the development of the KC9 IgG1 monoclonal is described, binding to an antigen secreted during invasive hyphal growth of the pathogen. The lateral flow test was then developed alongside the Chembio Cube reader and Lateral Dx Visual Score Card to measure test signal. The resulting accurate and low-cost lateral flow device provides a rapid result within a 30 minute time frame, and with high sensitivity (~50 ng/mL running buffer) detection of the polysaccharide biomarker. This is the first time that a quick and sensitive lateral-flow test for Mucormycosis has been reported, providing a point-of-care test for the disease.
Providing healthcare professionals with a fast and specific test with high sensitivity and at a low cost would solve several of the current diagnostic issues that healthcare professionals face with this fungal disease.
Dr Christopher Thornton, Director of ISCA Diagnostics, which is a University of Exeter spin-out company, is a specialist in bench-to-bedside translation of hybridoma technology to the medical and veterinary sectors, providing access to highly specific monoclonal antibodies for research and diagnosis of human and animal mycoses. He said of this recent project: “We’re pleased to have partnered with Lateral Dx in the development of this novel diagnostic test for Mucormycosis. We are using the data to support commercialisation of the device as a near-patient test for this devastating disease. In addition, we have now partnered with Lateral Dx to develop a multiplex testing system for the disease.”
Richard Campbell, MD of Lateral Dx, the lateral flow development experts said: “We’re extremely proud to continually partner with ISCA Diagnostics on diagnostic solutions for emerging pathogens of concern and welcome the opportunity to work with businesses or universities on developing cost-effective lateral flow solutions from short Proof of Principle studies all the way through to supporting large scale manufacture.”
From lateral flow development to rapid antibody screening solutions, Lateral Dx has over 20 years’ experience in the lateral flow assay industry supporting businesses across veterinary, human clinical, environmental and drugs of abuse. Quantitative data is available in as little as two weeks for your project, so find out more about our cutting edge technology or contact us today for more information.