Research & Development
Research and Development (R&D) is at the heart of the Companys business activity. The introduction of new products is key to the Companys competitiveness and future growth.
The Biotec R&D team is based in the United Kingdom and in Cape Town, South Africa. The team interacts closely with all other functions within the Company to ensure that feedback from the market and regulatory requirements are built into the ongoing research and development plan. The R&D work is managed to ISO 9001:2000 standards in line with the management of all activities within the Company. All clinical evaluations undertaken are also subject to local ethical review.
The Companys R&D activity is focused on a novel, patent-protected technology, Phage Amplification Technology. This is a generic technology that enables rapid and specific detection of viable bacteria. The Company has both negotiated exclusive licenses to aspects of the technology, as well as ownership of patents. The Company actively seeks to protect further inventions relating to the ongoing R&D activities. Phage amplification technology has potential for application to a number of different bacteria in a range of different markets.
Use of phage amplification for diagnosis and drug susceptibility testing of tuberculosis (TB)
The focus of the R&D team is on the application of phage amplification technology to the rapid diagnosis and drug susceptibility testing of TB. The culmination of the first phase of this work was the commercial launch of the first phage amplification product FASTPlaqueTBTM in 2000.
Subsequent developments of the technology have led to the launch of two new products in 2005, the FASTPlaque-Response test for rapid rifampicin resistance testing directly from smear-positive sputum, and NOA Antimicrobial Supplement, an accessory product for contamination control to be used in conjunction with the FASTPlaque-Response test.
The R&D team collaborates closely with experts in various fields of TB diagnosis and patient management, drug susceptibility and laboratory testing. Such collaborations have contributed to ongoing development projects, clinical evaluations, as well as recommendations for test implementation.
International agencies, such as the World Health Organisation through its Tuberculosis Diagnostics Initiative, give recommendations on design and performance characteristics that new products for TB diagnosis should meet. The Company is working closely with such agencies to ensure that its products meet these specifications. The Company has a co-development agreement with the Foundation for Innovative New Diagnostics (FIND), a not-for-profit organisation aimed at making available new diagnostics for use in the public sector of low-income countries. This agreement includes support of the development of FASTPlaque-Response as well as improvements in sensitivity of the FASTPlaqueTB diagnostic test.
The R&D team is involved in several key activities in the TB diagnostics field:
Further developments of the FASTPlaqueTB diagnostic test to improve performance of the test.
Enhancing the ease-of-use of the tests by investigating alternate test formats.
Other applications in TB diagnosis
Application of the technology to rapid susceptibility testing of other first-line drugs, particularly isoniazid, and second-line TB drugs.
Use of phage amplification for detection of other mycobacteria, particularly Mycobacterium avium subsp, paratuberculosis (MAP) in milk and other samples.
Use of phage amplification for detection of other bacteria
Phage Amplification Technology originated from work on the detection of food-borne pathogens. There is significant potential still to be exploited with the use of this technology in such applications, as well as other clinical, veterinary and environmental sectors.
Other phage applications
The Company has considerable broader experience in the propagation, manufacture and use of a range of bacteriophage for diagnostic and other uses.
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