Pricing
• Cost of equipment – <500 USD
• Cost of consumables (reagents/test strips) – <5 USD/test
3 Applications of Defining TPPs
3.1 TPP for Tuberculosis (TB) Diagnostics
Tuberculosis (TB) is one of the leading causes of deaths worldwide. Ten million
people were diagnosed with TB, and 1.6 million died from the disease in 2017
[13]. With one-third of cases not reported and patients not undergoing drug susceptibility tests (DST), the new and improved diagnostic kits for TB could help to detect
more cases and reduce diagnostic delays and transmission of the disease. Considering the gravity of the disease worldwide, resistance for the multiple TB drugs in the
market and inspired by the success of Xpert MTB/RIF diagnostics, particularly in
South Africa, investors and diagnostic companies have shown significant interest
in TB diagnostics [14–16]. In order to develop a promising TB diagnostic kit, it is
important to have a detailed target product profile (TPP) to understand the end user
needs, market competition, and specifications.
In order to address the unmet needs, the Bill and Melinda Gates Foundation and
Grand Challenges Canada have supported several ongoing activities globally and
also announced grants to support the development of the diagnostics in global health.
Nine potential TPPs were determined by a panel of experts from ten different
countries at the TB Modelling and Analysis Consortium (TB MAC) meeting, held
in 2013, which were further used to set the ten criteria and priorities in terms of
market potential of the test, impact of the test on TB transmission, mortality and
morbidity, as well as implementation and scalability of the test [17]. Each criterion
was rated as high, medium, or low priority. The highest score was for a rapid,
sputum-based, molecular test for microscopy centers (with the option of add on DST
cartridge), followed by a rapid biomarker-based, instrument-free test and for
non-sputum samples (that also detects childhood and extrapulmonary TB). TPPs
that were ranked lowest score could not directly diagnose TB and could be used as a
rule-in or rule-out method for TB detection. Due to their relatively low market
potential, they were ranked low on their ability to reduce TB mortality and morbidity
cases. Based on the obtained results, efforts are underway to develop detailed TPPs
for the rapid sputum-based molecular test and a biomarker-based assay, which have
been ranked first and second in the abovementioned assessment.
The impact of the TPP criteria can be readily gauged by looking at the current
trends of diagnostic research, with increasing emphasis being laid on the development of POC tests or devices, capable of swiftly yielding highly accurate results in a
limited resource setting in sputum directly. Recently, Lavania et al. reported an
202
H. Kaur et al.
• Cost of equipment – <500 USD
• Cost of consumables (reagents/test strips) – <5 USD/test
3 Applications of Defining TPPs
3.1 TPP for Tuberculosis (TB) Diagnostics
Tuberculosis (TB) is one of the leading causes of deaths worldwide. Ten million
people were diagnosed with TB, and 1.6 million died from the disease in 2017
[13]. With one-third of cases not reported and patients not undergoing drug susceptibility tests (DST), the new and improved diagnostic kits for TB could help to detect
more cases and reduce diagnostic delays and transmission of the disease. Considering the gravity of the disease worldwide, resistance for the multiple TB drugs in the
market and inspired by the success of Xpert MTB/RIF diagnostics, particularly in
South Africa, investors and diagnostic companies have shown significant interest
in TB diagnostics [14–16]. In order to develop a promising TB diagnostic kit, it is
important to have a detailed target product profile (TPP) to understand the end user
needs, market competition, and specifications.
In order to address the unmet needs, the Bill and Melinda Gates Foundation and
Grand Challenges Canada have supported several ongoing activities globally and
also announced grants to support the development of the diagnostics in global health.
Nine potential TPPs were determined by a panel of experts from ten different
countries at the TB Modelling and Analysis Consortium (TB MAC) meeting, held
in 2013, which were further used to set the ten criteria and priorities in terms of
market potential of the test, impact of the test on TB transmission, mortality and
morbidity, as well as implementation and scalability of the test [17]. Each criterion
was rated as high, medium, or low priority. The highest score was for a rapid,
sputum-based, molecular test for microscopy centers (with the option of add on DST
cartridge), followed by a rapid biomarker-based, instrument-free test and for
non-sputum samples (that also detects childhood and extrapulmonary TB). TPPs
that were ranked lowest score could not directly diagnose TB and could be used as a
rule-in or rule-out method for TB detection. Due to their relatively low market
potential, they were ranked low on their ability to reduce TB mortality and morbidity
cases. Based on the obtained results, efforts are underway to develop detailed TPPs
for the rapid sputum-based molecular test and a biomarker-based assay, which have
been ranked first and second in the abovementioned assessment.
The impact of the TPP criteria can be readily gauged by looking at the current
trends of diagnostic research, with increasing emphasis being laid on the development of POC tests or devices, capable of swiftly yielding highly accurate results in a
limited resource setting in sputum directly. Recently, Lavania et al. reported an
202
H. Kaur et al.