This platform provides test branding, marketing, and other services that are not core capabilities of the individual labs, as well as formal consultative services for the development of clinical diagnostics. It is a Pilot Granting Program for clinical lab test development. The Precision Diagnostics Platform is overseen by Dr. Colin Pritchard, MD, PhD, Associate Professor of Laboratory Medicine at the University of Washington.
The BBI CARET unit provides evaluation and consultation services for BBI-affiliated researchers on the potential of newly developed diagnostic approaches for use in clinical testing. We support for pilot studies for test validation human samples. Our goal is to help translation of new tests into clinical care in partnership with BBI-affiliated laboratories.
Request a CARET consultation with: Brian Shirts, MD, PhD; Associate Director of Laboratory Medicine at shirtsb[@]uw[.]edu
A: The Clinical Application of Research in Emerging Technologies unit is a service to help basic science and medical researchers translate their ideas into diagnostic tests. The CARET unit provides free consultation services to BBI-affiliated researchers on the potential of new diagnostic approaches for use in clinical testing at BBI-affiliated laboratories, supports pilot studies for testing such methods with human samples, and helps translate of new tests into clinical care. There are over 10 clinical laboratories that are part of the BBI Precision Diagnostics Platform with over 40 affiliated faculty experts in clinical diagnostic test development.
The CARET unit also provides fee-based consultation services to non-BBI researchers and companies. The purpose is to provide expert consultation to researchers interested in translating emerging technology into the clinical diagnostics. The CARET unit is supported by BBI.
A: Anyone who thinks they have developed technology that could be used in medical diagnosis and is affiliated with BBI sponsor institutions, the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Children’s can request a CARET consultation. The CARET unit also provides fee-based consultation services to non-BBI researchers and companies.
A: After the initial request is complete the CARET director will assign the request to a CARET consultant, usually within a week. CARET consultants are faculty with experience in research, diagnostic test validation, and clinical diagnostics. CARET consultants are usually able to schedule an initial meeting within two weeks of being assigned a request. Each evaluation is unique and tailored to the researcher, technology, and potential diagnostic impact. If all relevant information is available the researcher and CARET consultant may decide to move forward with validation after the initial meeting. In other situations, there may be more information or preliminary work necessary to determine if a new technology is ready for translation to a diagnostic test.
A: The validation and implementation process usually takes 1 to 2 years, but can take longer. Very rarely, a service that is very similar to existing services can be validated and implemented in a shorter time.
A: No (with rare exceptions). A Supreme Court decision in 2012 established that most clinical lab test services are based on natural phenomena, and therefore excluded as patentable subject matter. For example, many tests detect levels of a natural substance that correlate with the presence or absence of disease, and this is considered a natural phenomenon rather than something invented by human ingenuity.
New computational and analysis methods may be patentable in theory, but are rarely practical to patent as the diagnostic results are on detecting natural correlations and slightly different non-patented strategies are likely to yield similar results.
Engineered diagnostic machines or chemical substances that are used in diagnostics are often patentable. CARET will refer these to the Institute for Translational Health Sciences (ITHS) Preclinical Consulting service or to institutional tech transfer offices (see below).
A: There is no direct compensation for implementation of clinical tests. Clinical test pricing is cost-based, designed to recover only the costs of performing the assay. Most assays developed in research settings are low-volume procedures that typically are not able to recover the cost of performing the test. These are implemented not because of financial incentives, but because of their potential to improve patient care.
A: Researchers often find that the indirect benefits, financial and nonfinancial, can be significant. For example, availability of a clinical test service can allow one to apply for research grants or contracts that require testing on human subjects. Having a validated clinical test enables clinical trials. Data gathered from validation and clinical testing programs can often enhance the quality of grant proposals and the researcher’s reputation for effective translation of research into clinical practice. Researchers who are also practicing clinicians may find a new test service increases patient referrals to their outpatient clinics. Finally, there can be considerable personal satisfaction from knowing that one’s research is having a tangible impact on individual patients.
A: Because most diagnostic technology is not patentable, tech transfer is usually not involved. CARET will recommend referral to Institute for Translational Health Sciences (ITHS) Preclinical Consulting service or to UW CoMotion, Fred Hutch Business Development, or Seattle Children’s Technology Commercialization for those technologies that are likely to be patentable, require substantial private investment and/or, require an industry manufacturing partner in order to be eventually implemented in clinical care. This is typically the case for new technologies that would be implemented in the form of a new instrument or a new chemical process. The ITHS and/or institutional technology transfer offices will advise researchers on the potential for patenting and developing their technologies.
You may already be working with a tech transfer office or with a startup company. If this is the case CARET consultation services may still be available to you, but there is more legal paperwork to maintain intellectual properties and consultation fees for CARET services may apply.
A: No. CARET will facilitate “matchmaking” with an existing CLIA laboratory. There is substantial overhead and increasingly complicated rules related to running a successful clinical laboratory. Specialized training is required to be listed as a director of a clinical laboratory. A clinical laboratory is involved in many activities that are not typical even in large research groups, these include: the ability to receive and process samples, bill for testing, negotiate with payors, send results through hospital interfaces, and document each of these processes accurately. There are over 10 clinical laboratories that are part of the BBI Precision Diagnostics Platform with over 40 affiliated faculty experts in clinical diagnostic test development. These laboratory directors are eager to implement new tests that have promise to benefit their patients. Because of this, the goal of CARET is to connect researchers with existing clinical laboratories.
A: Faculty that are part of the CARET team have been successfully partnering with researchers and clinicians to develop new diagnostic tests for many years. Although there are many success stories, we have not formally tracked this in the past. We are beginning to track this, and we will update this answer as soon as the data is available.