Validation and Integration of a New Test to Improve the Diagnosis of Tuberculous Meningitis
The University of Cape Town Lung Institute in partnership with Antrum Biotech (Pty) Ltd, the Malawi College of Medicine and Biomedical Research and Training Institute (BRTI) are validating a new test to diagnose tuberculous meningitis. The test detects a biomarker in cerebrospinal fluid (CSF), where elevated levels suggest the TB disease. Through the support of the BioFISA II Programme, the project will generate clinical performance data at sites in Malawi, South Africa, and Zimbabwe, and facilitate the development of a dossier for pre-market regulatory approval from national bodies, endorsement from the World Health Organisation (WHO) and access to international donor markets.
• Patient recruitment and sample bio-banking commenced across all 3 sites. The goal of 750 participants consented to the study has been achieved and surpassed. South Africa, Malawi and Zimbabwe have consented 250, 250 and 333 participants, respectively. Recruitment will continue until 31 August 2018 so as to enhance the power theaccumulated data for IRISA-TB endorsement.
• A preliminary cut-off has been determined, showing superior performance when compared to competitor products. This will be validated during the next phase of the project.
• The customer segment has been engaged, the market has been defined and the cost of goods sold (COGS) determined. In terms of sustainability, Antrum Biotech (Pty) Ltd has secured additional funding for IRISA-TB development, manufacturing and/or multisite clinical performance studies.
OUTCOME AND IMPACT
The developed in vitro diagnostic device (IVD) proposes to replace less accurate products with a rapid more sensitive test to provide improved access to life saving treatment for TB meningitis. The greatest need for the test is in populations with a high burden of tuberculosis and human immunodeficiency virus (HIV) (including children) in sub-Saharan Africa.
Prof. Keertan Dheda
Principle Investigator – South Africa
Unit Head, Lung Infection and Immunity Unit, UCT Lung Institute
Dr Philippa Randall
Project Manager – South Africa
Head of Diagnostic Group, Lung Infection and Immunity Unit, UCT Lung Institute
Ms Khilona Radia
Commercial Partner – South Africa
CEO Antrum Biotech (Pty) Ltd.
Dr Junior Mutsvangwa
Project Coordinator – Zimbabwe
Biomedical Research and Training Institute
Dr Marriott Nliwasa
Project Coordinator – Malawi
College of Medicine