E-DRUG: Rapid TB diagnostic test by 2005?
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[After the Foundation for Innovative New Diagnostics (FIND) was announced in
May 2003, we didn't hear much. Recently the following press release came
out, promising a new rapid diagnostic test for TB by 2005. "rapid" = < 48
hours. See http://www.finddiagnostics.org/index.htm WB]
FIND speeds development of rapid economical TB tests with Biotec
Laboratories
Aim to provide Tuberculosis tests yielding results within 48 hours, rather
than weeks
First new TB test to be available in 2005
The Foundation for Innovative New Diagnostics (FIND) and Biotec Laboratories
Ltd [info]. this week announce a milestone that will speed the process of
delivering simple, rapid diagnostic tests for tuberculosis to developing
countries.
Following the launch of FIND in May 2003 at the World Health Assembly, its
first development agreement has been signed with Biotec Laboratories Ltd, an
established independent UK company with expertise in the development of a
number of diagnostic products.
FIND�s involvement will accelerate the development, evaluation and
demonstration of two improved diagnostic tests that use Biotec�s FASTPlaque
technology [info]. One of these tests will enable rapid and sensitive
detection of tuberculosis (TB) [info] in patients seeking a diagnosis, while
the other will be used in TB cases to detect multi-drug resistance directly
from sputum.
The development target is a test that is as accurate as culture, the current
internationally recognised standard, but that gives results in 48 hours
rather than several weeks, and that uses a simple manual procedure that is
easy to perform in routine laboratories.
The FIND investment will be used primarily to enhance the capacity of Biotec
�s R&D facilities in Cape Town, South Africa, which will accelerate the
development of these tests.
�Improved case detection is the highest priority for TB Control. This
technology has the potential to replace existing slow culture methods,
boosting TB case detection far above that achieved with microscopy alone by
bringing a rapid and sensitive test to developing country laboratories�,
said Dr Mark Perkins, Chief Scientific Officer of FIND.
FIND, a non-profit organisation, will leverage its development investment
with Biotec to ensure affordability of the tests for low-income countries
where they are most urgently needed. Under the terms of this agreement, FIND
has obtained a royalty-free license for the use of this technology in the
public health sector of low-income countries, with Biotec retaining
exclusive rights for the private health sector in low-income countries and
all markets in high income countries.
�Through this unique partnership, we are addressing the critical need for
improved diagnostic tests for tuberculosis. Our investment in Biotec�s
FASTPlaque technology signifies real progress - we are aiming for
availability of these tests as early as 2005� said Dr Giorgio Roscigno,
Chief Executive Officer for FIND.
Ian Dalgleish, Chairman of Biotec said, �This is an exciting new
partnership. FIND is changing the way that TB diagnostics are developed. By
applying their considerable expertise and financial resources in such a
focused way, FIND will dramatically accelerate our new product development
programme, and help to open up those markets where the need for new, simple,
rapid TB diagnostics is most acute. We are very encouraged by this
endorsement of the considerable effort and investment Biotec has already
made in developing this technology into a valuable product.�
One use of these new FASTPlaque tests is to screen for rifampicin resistant
strains directly from sputum. FIND is collaborating with the
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in
Tropical Diseases (TDR) to evaluate the accuracy and effectiveness of this
newly developed test for drug resistance that gives a result in 2 days.
Existing indirect methods to detect drug resistance in TB give results only
after weeks to months of delay, which markedly decreases their utility for
patient care.
�We are very happy to hear about this progress from FIND, the lead Agency
for Diagnostics of the STOP TB Partnership� said Dr Marcos Espinal, the
Partnership�s Executive Secretary. �Moreover, this announcement coincides
with the release of the World Health Organisation third global report on �
Anti-TB Drug Resistance in the Developing World� This report highlights the
utility of rapid rifampicin resistance tests in TB to predict multi-drug
resistance in areas where it is prevalent�.
[More info at: http://www.finddiagnostics.org/news/docs/clinica_may04.pdf\]
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