Supporting and Developing NYC Biotech
Low cost diagnostics for tuberculosis detection
Despite success in eliminating tuberculosis (TB) and drug resistant TB (DR-TB) as a major health concern in the US, this global epidemic still kills 1-2 million people each year. In low income countries where TB is endemic, early accurate diagnosis coupled with appropriate treatment is essential to control the spread of disease and the emergence of DR-TB. In South Africa, the century-old technique of sputum smear microscopy is being replaced with the more accurate, rapid and sensitive Xpert MT/RIF system. This PCR based diagnostic represents a significant advance in TB diagnostics since it can diagnose a case of TB in less than two hours, allowing a patient to receive treatment quickly. Ideally, in countries where TB and DR-TB are endemic, the Xpert MT/RIF would be extensively deployed so that no one would have to travel more than 1-2 hours to obtain an accurate diagnosis. However, the machines are expensive, and the consumable reagents require refrigeration, a luxury in some areas where TB is common. For these reasons deployment of the Xpert MT/RIF system will likely be limited to well equipped hospitals and reference laboratories, away from patients with the greatest need for easy access to such a medical diagnostic.
Preliminary results using synthetic mycobacteriophages demonstrate the potential of using these TB-specific viruses as the core technology in a point-of-care medical device capable of detecting the presence and quantity of TB and DR-TB in a patient sputum sample. Constructed with design features such as high sensitivity, long shelf life of consumable reagents, safe and easy operation in communities without electricity and running water the “Bronx Box 2.0” will be a prototype for a low cost, mass manufactured and disposable device capable of providing an accurate diagnosis for TB or DR-TB in settings such as community health centers and rural clinics. Upon successful testing, a Phase II application to fund large scale production of the final optimized Bronx Box 2.0 will be submitted.
Our collaborator Dr. Jacobs has been the leader in developing synthetic phage technology, and holds the patents for the phages that will be used to create the Bronx Box 2.0. In addition, his lab will test the prototype Bronx Box 2.0 using clinical strains of DR-TB in their BSL-3 lab to ensure the that it functions according to specifications. In addition, Dr. Jacobs has an ongoing research project in collaboration with clinical scientists studying HIV/TB coinfection in South African patients, and can provide unique insight into additional design features that should be incorporated into the prototype.