Geneva, Switzerland --
Today FIND and Hain Lifescience (Hain)
announced an agreement to jointly accelerate the
development, evaluation and implementation of a
molecular test to screen for multidrug-resistant
tuberculosis (MDR TB). The test, which will
detect rifampin and isoniazid resistance as
markers for MDR TB, is currently marketed for
use only with culture isolates, which may take
weeks to obtain. FIND will evaluate an adapted
version of the test for use directly from sputum
in patients with advanced (microscopy-positive)
disease, dramatically speeding the detection of
drug resistance by giving next-day results.
Under the terms of the agreement, Hain will
offer the test at an affordable price for use in
TB-endemic countries.
The collaboration is a rapid response to
recently highlighted outbreaks of untreatable
and potentially rapidly fatal TB with extensive
drug resistance (XDR TB) detected in South
Africa and other countries. Detecting and
effectively treating MDR TB helps prevent the
development of XDR TB.
“Rapid, effective and affordable diagnostics
are essential to treat patients and prevent the
spread of multi drug resistant TB,” said Dr.
Giorgio Roscigno, FIND CEO. “We are very happy
to have signed this agreement with Hain as their
molecular technology fits well within our
portfolio and the world urgently needs new tools
to detect MDR and XDR TB”.
The Hain GenoType® MTBDR test relies on PCR
(polymerase chain reaction) amplification of
bacterial genes and hybridization on a strip
bearing probes to specific resistance-associated
gene segments. The test provides results
predicting resistance to rifampicin and
isoniazid in one day. Conventional solid culture
is currently the most common method used to
detect drug resistance in developing countries
and may take two to three months to produce
results. If Hain’s assay proves feasible and
effective when performed directly on
microscopy-positive sputum specimens, it could
provide an important new weapon in the battle
against emerging drug resistant TB.
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Background, from left to right: Michael Weizenegger
(Hain),
Mark Perkins (FIND), Catharina Boehme
(FIND)
Foreground, from left to right: Rick O’Brien (FIND),
David Hain,
Giorgio Roscigno (FIND) |
David Hain, General Manager of Hain said: “We
are proud to have formalized this agreement and
commit to working with FIND to make this product
affordable and available in developing countries
as soon as possible. We also hope that our
technology can help prevent the spread of MDR
and XDR TB.”
Developed by Hain, the molecular test has
been approved for use in various European
countries, but its adaptability to field
conditions in developing countries is currently
being confirmed in collaboration with FIND. As a
leading public private partnership in the
development of diagnostics for diseases for
poverty related diseases, FIND will coordinate
the evaluation and implementation studies in
high endemic countries.
The Foundation for Innovative New Diagnostics
(FIND) is a non-profit foundation focused on the
development of diagnostics for poverty related
diseases. Hain Lifescience is a private, German
based manufacturer and supplier of modern
diagnostics systems. This is the first agreement
signed between FIND and Hain.
