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In Vitro Diagnostics

Target Product Profile Framework Offers Guidance to Avoid Developmental Traps

When the COVID-19 pandemic was declared by the WHO (World Health Organization) in the spring of 2020, public health officials were rapidly seeking diagnostic testing solutions to help address the public health crisis. The diagnostic field witnessed a large infusion of support at that time, as funds were allocated for In Vitro Diagnostic (IVD) devices for the SARS-CoV-2 virus. At the time, the US National Institutes of Health (NIH) launched their RADx program, which was instrumental in rapidly evolving the COVID-19 testing enterprise by supporting research and development of IVD developers’ Emergency Use Authorization (EUA) submissions to the U.S. Food and Drug Administration (FDA). According to published statistics, the cumulative production of five billion COVID-19 tests, and 46 FDA EUAs of COVID-19 tests, including one for the first over-the-counter (OTC) molecular diagnostic test for the disease, can be attributed to the RADx program.

Unfortunately, not all funded projects were successful in receiving regulatory authorizations and reaching the market. Thus, funding alone was not sufficient to bridge from bench to bedside or what is commonly referred to as “the valley of death.” Many of these failures demonstrated the need for a refined development process. 

To meet this market need and help address emerging and novel biothreats and infectious disease threats that pose a constant challenge, several of our researchers defined a process for a well-developed Target Product Profile (TPP), which is central to successful in vitro diagnostic (IVD) device development. You can read their full research article at “Using a Target Product Profile (TPP) to guide innovation for future In Vitro Diagnostic (IVD) developments in the United States.”

For insight on COVID-19 variants and vaccines, read our blog “What to Expect from COVID-19 this Fall.”

What is a TPP?

A TPP is a key document that outlines the desired attributes of a target product that is aimed at a particular disease. The TPP framework can highlight technological gaps and focus developments on meeting specific needs that advance the field. A survey of various diagnostic technologies, such as those employed for respiratory disease diagnosis, reveals significant innovations that have been accomplished during the COVID-19 public health emergency. In particular, the TPP framework can be used to help identify remaining gaps in IVD design while highlighting potential focal areas for innovation that are needed to better align diagnostic testing performance with the comprehensive disease status of the individual. Nevertheless, the entire IVD diagnostic landscape continues to evolve, and it is important for device developers to identify the challenges and set appropriate targets to avoid pitfalls. 

While a TPP does not necessarily guarantee market success of an IVD, it is an important tool that can help developers define appropriate criteria for their device. A TPP can guide them through the multi-faceted development process to meet consumer demands, while ensuring clinical utility, safety, and effectiveness of their products. The following discussion highlights the TPP process for IVD device developments through the application of the basic tenets in various case studies. The aim is to help developers traverse the proverbial ‘valley of death’, where many great concepts fail to reach market success, and to encourage positive developments in the field beyond current IVD device limitations.

How a TPP Helps IVD Developers

The failure of many technologies to translate from bench to clinical practice is not necessarily due to the lack of an innovative approach. Many novel discoveries are centered around well-controlled laboratory conditions and fail to pass the crucible of practical and clinical needs. Therefore, a TPP should guide a developer through an extensive list of requirements to demonstrate the technology’s fitness for intended use, and ultimately its clinical utility. 

A test, for example, that successfully detects a marker of disease but requires invasive procedures to obtain a sample when simpler, safer diagnostic methods exist should quickly be identified by the TPP as unacceptable. A poor understanding of the true clinical need (not just the technical problem), positioning within the clinical workflow, and the overall risk vs benefit profile of a medical device often results in a high probability of the device failing validation and failing to be supported for clinical use. The consequences of missing such development outcomes can be devastatingly costly to both the developers and those in need of the product. Developers who use a TPP properly should steer clear of these developmental traps. 


Contact MRIGlobal for further information about our work with infectious diseases. Through an interdisciplinary approach, we provide scientific and subject matter expertise for development of medical countermeasures research against specific threats. We support medical device developers through our extensive test and evaluation facilities—including CLIA-certified labs, and experience in bringing devices through regulatory clearances.

To discuss how we can help your project be successful, contact us today.


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