At the very beginning of the diagnostic product development process, it is critical to identify and keep the end goal in mind: to impact a clinician’s ability to prescribe an appropriate course of therapy.
It is important to note that a critical requirement for commercializing a diagnostic is for your company to have a clear license or ownership of the intellectual property needed for your core technology.
All newly developed diagnostics should ideally be
- Rapid: The faster the better—minutes to a couple of hours.
- Sensitive: Sensitivity must be equivalent to or exceed that of the Food and Drug Administration (FDA)—cleared or internationally accepted diagnostic tests for the proposed pathogen, toxin, and/or human biomarker. If no FDA-cleared or internationally accepted test is available for these entities, a clinically relevant level of sensitivity will need to be established.
- Specific: Specificity must be equivalent to or exceed specificity of FDA-cleared or internationally accepted diagnostic tests for proposed pathogen, toxin, and/or human biomarker(s). If no FDA-cleared or internationally accepted test is available, a clinically relevant level of specificity will need to be established.
- Easy-to-Use: The diagnostic should be an integrated, closed sample-to-answer system with automated data analyses, and output should require minimal operator training and expertise.
- Random Access: The diagnostic should be able to run a sample or multiple samples as needed.
- Adaptable: The diagnostic should be capable of integrating new diagnostic tests for entities as required.
- Cost-Effective: In many instances, though not all, the cheaper the diagnostic, the better.
- The final product
- Market research—Who will use the diagnostic?
- Who will pay for the diagnostic test?
- Assessment – Does the diagnostic improve clinical decision-making and patient outcome?
- A Product Development Plan (PDP) is essential for commercializing a diagnostic
In the United States, FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of medical devices. Diagnostic products must be reviewed and cleared prior to use in medical decision-making. The FDA Center for Devices and Radiological Health (CDRH) regulates firms that manufacture medical devices sold in the United States. At a very early stage, it is important for infectious disease diagnostic developers to define the intended use(s) of a new diagnostic, as this is a main consideration for FDA regulation of every diagnostic device. The intended use of a diagnostic will influence the types of studies that will be needed to assure the safety, effectiveness, quality, and security of the new diagnostic. Examples of intended uses for diagnostic products are found within each decision summary and the product information obtained by querying the FDA 510(k) Premarket Notification Database.
The design and function of a new diagnostic will be determined primarily by its intended use(s) and the proposed diagnostic setting(s) where it will be used. When determining intended use, researchers should consider several factors. For example, what is the purpose of the new diagnostic?
- To aid in the diagnosis of infectious disease? If so,
- Which infectious disease(s)?
- Does at least one member of the research team have expertise with each intended use and knowledge of the clinical algorithms and decision-making process currently used to diagnose the disease?
- How will this diagnostic improve upon the current methods being used to detect each disease?
- To predict response to therapy?
- Will the diagnostic be rapid enough to impact a clinician’s therapeutic choice?
- To monitor response to therapy?
- What type(s) of information are clinicians currently using for this purpose?
- How will this diagnostic improve a clinician’s understanding of the disease progression in a patient?
The process to enable use of diagnostics for clinical decision-making varies for each country and should be considered and addressed as your research and development program is formulated. This is especially critical for diagnostics being developed for use in international, low-resource settings.
It is critical to determine the setting(s) where the proposed diagnostic will be used as this will
- Guide the design and operational requirements for the product
- Determine the settings where the clinical performance of the diagnostic must be assessed
- Identify the types of collaborations that will be required to obtain input on the design and operational requirements, as well conduct studies to test the prototypes, to assess the clinical performance of the diagnostic in support of FDA clearance and determine the cost-effectiveness of the diagnostic
Potential settings include public health laboratories, hospital-based clinical microbiology laboratories, and/or point-of-care use (e.g., physician’s office, health clinics, emergency department, at the bedside, low-resource settings). If the goal is for the diagnostic to be used in multiple settings, then the device must be designed to meet the combined requirements for all of these settings.
Once the intended use and diagnostic setting(s) have been determined, it is important to determine the commercial potential for the diagnostic based on its Intended Use and Potential Setting. For example
- How many potential user sites are there in the United States and other countries?
- What test(s) are these organizations currently using for this Intended Use (purpose)?
- How many of these tests are performed annually in this setting?
- What is the current average cost to perform the current test in this setting?
- How does the new test compare to the existing test in terms of actionable information provided to the clinician, personnel and expertise required to perform the test, time-to-result, shelf life, cost per test, etc.?
This will depend on the intended use and the proposed diagnostic setting(s). The potential payment for performing a diagnostic test varies by setting and will factor into the cost-effectiveness of the new diagnostic.
In the United States, the Centers for Medicare and Medicaid Services (CMS) sets the general policy for reimbursement provided to clinical laboratories for diagnostic testing, including large diagnostic testing companies such as Quest Diagnostics and Laboratory Corporation of America, and other entities, including hospital clinical laboratories. Private health insurers often use similar policies and reimbursement strategies. Consumers will be required to pay for "over-the-counter" (OTC) diagnostic tests not covered by health insurance.
For more information see
- Centers for Medicare and Medicaid Services (CMS)
- CMS: ICD-9-CM Diagnosis and Procedure Codes: Abbreviated and Full Code Titles
For diagnostics to be used in U.S. public health laboratories, it will be important to understand what their target cost is per test as these laboratories are supported by local, state, and federal governments who may have to comply with requirements unique to their governance structure
For diagnostics to be used in low resource settings such as public health clinics, rural settings, or developing countries, there may be potential partnerships through foundations, charitable organizations, international governments, and/or international organizations, to support the purchase, distribution, and performance of the diagnostic tests.
While reimbursement rates factor into the cost-effectiveness of a diagnostic, it is not the only determinant of cost-effectiveness. It is possible to demonstrate, preferably through published studies, that while the cost of the diagnostic test is higher than the current test, it provides a level of additional value (information, reduced time to prescribe appropriate therapy, etc.) that improves patient outcomes and reduces downstream patient costs (reduced number of follow-up tests, reduced time in the hospital, follow-up visits to the primary health care providers, etc.). The data from these studies can be critical to attain commercial acceptance and success of the diagnostic.
Developing and bringing to market a diagnostic is a lengthy endeavor so it is important to envision the final product at the initial step in the process, and to develop a plan to achieve this objective. A PDP is a strategic document outlining the complete process of developing and bringing a diagnostic to market. It is important to draft a PDP at the beginning of the process and periodically update it as development proceeds. As a PDP is developed or updated, it may be useful to consider attending a course that focuses on issues associated with moving a diagnostic product from concept through regulatory approval and market launch, and/or involve consultants with experience developing and launching diagnostic products. NIAID provides services to facilitate preclinical development of diagnostics for infectious diseases, including assistance with developing product development plans. For more information please contact DMID staff for the relevant disease area.
Additional FDA websites of possible relevance to new diagnostic developers