[Ip-health] Innocentive's prize for a rapid TB diagnostic test.

[James Love]

Innocentive's prize for a rapid TB diagnostic test.

The amount of the prize, $60,000 USD, seem very modest, given the
importance of the test, and the conditions regarding IPR.

(The proposed diagnostic test must offer the Seeker "freedom to
practice", i.e. there either should be no intellectual property rights
blocking the use of the solution, or intellectual property rights needed
to practice the solution must be available for license.)

It might be interesting for governments or other donors to think about
funding this type of prize at a much larger amount (for example, adding
one to 3 zeros to the prize), and making sure the invention is freely
licensed to manufactures of the test.  Jamie


https://www.innocentive.com/servlets/project/ProjectRoom.po?id=5467895

INNOCENTIVE 5276936
TB Diagnostic Test
$60,000 USD
POSTED: Jul 16, 2007
DEADLINE: Oct 16, 2007
STATUS: OPEN

The Seeker is looking for a simple, rapid and sensitive test to detect
Mycobacteria tuberculosis (M. tb), the bacteria causing tuberculosis. In
particular, the Seeker is interested in rapid tests that can diagnose
active tuberculosis disease.

Tuberculosis affects over two billion people each year and kills over
one million of them. The cause of tuberculosis is the infectious
bacteria, Mycobacteria tuberculosis. There is an urgent need for a rapid
test for the detection of active M. tb disease in clinical samples that
is also highly sensitive and simple. The desired simplicity of the test
is dictated by the fact that most cases of tuberculosis occur in
developing countries with limited resources and skilled personnel.

Currently, M. tb detection includes staining of sputum smears with
Ziehl-Neelsen (Acid Fast Bacilli (AFB) staining). The major problems
with this protocol are low sensitivity, dependence on microscopy, and
lack of specificity for M. tb.

Microbiological culturing from sputum is also used to detect M. tb.
However, culturing M. tb is complicated and time consuming. A number of
serological tests have also been developed for detecting M. tb.
Unfortunately, they too have demonstrated variable sensitivity and
specificity for detecting active M. tb disease.

The Seeker is therefore looking for a direct detection of M. tb in
patient samples, not restricted to sputum, that is rapid, sensitive and
specific for M. tb. The Seeker requires that the proposed diagnostic
test be effective with both HIV-negative and HIV-positive samples and be
suitable for large-scale testing of patients in field conditions. The
Seeker also envisions that the proposed diagnostic test involves a
minimum number of steps and eventually is made available to countries
with limited financial resources.

The Seeker poses no restrictions with regard to the nature of a
biomarker used for M. tb detection. Nor are there any restrictions with
respect to the test format as well as to the type of sample(s) needed to
be collected. However, the Seeker will have clear preference for simple
inexpensive assays that use low-cost, commercially available, equipment.

The Seeker is very well familiar with voluminous literature on potential
biomarkers for detection of M. tb. However, it believes that the data
proving clinical relevance of the biomarkers proposed so far are
missing. It will therefore be absolutely critical for the Solvers to
demonstrate the clinical utility of biomarker(s) they propose for the
diagnostic test in question.

The proposed diagnostic test must meet the following requirements:

   1. The proposed diagnostic test must be rapid, i.e. must be able to
deliver analytical results in less than 1 hour.

   2. The proposed diagnostic test must be sensitive enough to
positively identify more than 95% of clinical samples detected as smear
positive by Ziehl-Neelsen sputum (Acid Fast Bacilli (AFB) staining).

   3. The proposed diagnostic test must also be sensitive enough to
positively identify more than 80% of clinical samples containing M. tb
and other Mycobacteria related to tuberculosis even if the samples stain
negative by Ziehl-Neelsen sputum (Acid Fast Bacilli (AFB) staining).

   4. The proposed diagnostic test may use a variety of clinical samples
such as sputum, blood, and urine.

   5. The proposed diagnostic test must be effective with both
HIV-negative and HIV-positive samples.

   6. The proposed diagnostic test must be simple enough to be conducted
by health professionals in conditions of limited resources, including
limited power supply.

   7. All materials and reagents employed for the proposed diagnostic
test must be safe for human use and environmentally friendly. The
chemical agents, for example, must be TSCA (Toxic Substances Control
Act, http://www.epa.gov/region5/defs/html/tsca.htm) and EINECS (European
Inventory of Existing Commercial Substances,
http://ecb.jrc.it/Einecs-List/) approved.

   8. Radioactive-labeled materials and toxic materials cannot be used
in the proposed assay.

   9. The Solvers are expected to provide cost estimates and reagent
information on component(s). The Seeker will have clear preference for
simple inexpensive assays that use low-cost equipment.


The Solver must first provide a detailed description of the proposed
diagnostic test.

When describing the diagnostic test, the Solvers must clearly identify
and describe the required biomarker (endpoint). Detailed
characterization of the endpoint(s) and how these endpoints are measured
(including internal controls) must be articulated. Finally, a
step-by-step protocol of sample preparation must be presented (if
applicable).

If asked by the Seeker, the Solvers will validate their proposals. The
Seeker will provide more detailed protocols for testing to chosen
Solvers.


Project Criteria
The Seeker is looking for a rapid and sensitive diagnostic test to
detect M. tb in clinical samples from patients with active disease that
are highly specific for M. tb.

Step 1. Within 3-month period, the Solvers must submit a written
proposal with a detailed description of the approach that will achieve
the desired objective. The description must include a well-written
rationale supported by literature/patent precedents and references.

The Seeker will evaluate the submitted written proposals and, within 1
month of receipt, will select one or more submissions for further
evaluation. The Solvers whose submissions are selected will be awarded
up to $15,000 contingent upon the transfer or license of intellectual
property rights to their solution to the Seeker.

Step 2. The Solvers whose submissions are selected and awarded
(contingent upon the transfer or license of intellectual property rights
to their solution to the Seeker) may have an opportunity to provide,
within a 2-month period, experimental data in support of their ideas.
The Seeker will provide more detailed protocols for testing to the
Solvers.

Following the submission of the experimental data to the Seeker, a final
evaluation of the submissions will be conducted within a 2-month period.
The proposal and data package that best meets the criteria of the
challenge will be awarded up to $60,000 (including the initial up to
$15,000 award). The Seeker reserves the right to award only the most
cost-effective solution.

The Seeker is not looking for just a review on the subject. The proposed
diagnostic test must offer the Seeker "freedom to practice", i.e. there
either should be no intellectual property rights blocking the use of the
solution, or intellectual property rights needed to practice the
solution must be available for license.