2.2 Features of a TPP
In order to develop the business strategy for TPPs and quantify the potential market
value, five key differentiating features must be put in place for product positioning,
raising capital, and discussions with investors and key stakeholders. The key features
are discussed in detail below:
1. Statement of intended use: This section of the TPP provides a brief description of
the assay or product under development. The following questions need to be
addressed by the stakeholders during this phase of product development:
• What is the purpose of the assay? Is it for screening, monitoring, or diagnosis?
• What is the target population? Is it limited to a particular geography or
demographics?
• Is it a quantitative or qualitative diagnostic assay? How can the end result(s) be
expected, and how can it assist the physician to understand the entire clinical
picture and take a well-informed decision related to the treatment?
• What is the analyte or marker of interest? Is it well characterized or validated
for the assay development?
• What instruments or additional diagnostics tests are required to execute the
assay?
• What is the “gold standard” against which performance of your test will be
compared?
2. Brief explanation of test: A concise summary about the diagnostic test along with
the usefulness to the patients is helpful to complete this section of the TPP.
Questions raised during this section could be as follows:
• What is the intent of the test?
• What kind of test will it be? Is it a point-of-care test, laboratory test, or use at
home test?
• What analytes can be detected from the test?
• Does the test and target of interest need to be validated per the regulatory
guidelines?
• What could be accomplished from the test?
• When should the test not be used for detection?
3. Summary of test procedure: A good understanding about the simplicity or
complexity of the diagnostic test is useful to determine whether or not the target
location is ideal for performing the test. For simple and easy-to-use diagnostic
kits, such as glucose level monitoring or pregnancy detection, robustness and
reliability would be important. On the other hand, complex laboratory tests, such
as pathogen detection or tumor biopsy in a clinical laboratory, must be carried out
under the supervision of trained and qualified laboratory personnel. The following questions need to be addressed in order to complete this section:
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In order to develop the business strategy for TPPs and quantify the potential market
value, five key differentiating features must be put in place for product positioning,
raising capital, and discussions with investors and key stakeholders. The key features
are discussed in detail below:
1. Statement of intended use: This section of the TPP provides a brief description of
the assay or product under development. The following questions need to be
addressed by the stakeholders during this phase of product development:
• What is the purpose of the assay? Is it for screening, monitoring, or diagnosis?
• What is the target population? Is it limited to a particular geography or
demographics?
• Is it a quantitative or qualitative diagnostic assay? How can the end result(s) be
expected, and how can it assist the physician to understand the entire clinical
picture and take a well-informed decision related to the treatment?
• What is the analyte or marker of interest? Is it well characterized or validated
for the assay development?
• What instruments or additional diagnostics tests are required to execute the
assay?
• What is the “gold standard” against which performance of your test will be
compared?
2. Brief explanation of test: A concise summary about the diagnostic test along with
the usefulness to the patients is helpful to complete this section of the TPP.
Questions raised during this section could be as follows:
• What is the intent of the test?
• What kind of test will it be? Is it a point-of-care test, laboratory test, or use at
home test?
• What analytes can be detected from the test?
• Does the test and target of interest need to be validated per the regulatory
guidelines?
• What could be accomplished from the test?
• When should the test not be used for detection?
3. Summary of test procedure: A good understanding about the simplicity or
complexity of the diagnostic test is useful to determine whether or not the target
location is ideal for performing the test. For simple and easy-to-use diagnostic
kits, such as glucose level monitoring or pregnancy detection, robustness and
reliability would be important. On the other hand, complex laboratory tests, such
as pathogen detection or tumor biopsy in a clinical laboratory, must be carried out
under the supervision of trained and qualified laboratory personnel. The following questions need to be addressed in order to complete this section:
Defining Target Product Profiles (TPPs) for Aptamer-Based Diagnostics
199