Proposals that are driven by “clinical pull” responsive to unmet clinical needs have a much higher probability of clinical impact and commercial success than those driven by “technology push”. Each Center in the POCTRN network conducts needs assessments focused on its domain of practice as summarized below.
We welcome your opinions regarding unmet clinical needs and what qualities are needed to make POC tests that are efficient, effective, meaningful, and can influence public health positively.
As the number of primary care providers diminishes and the need for primary care increases, the fundamental unmet need is to increase the ability of providers to care for more patients without decreasing the quality of care given and without unduly burdening the providers, patients or their families.
In general, two POC technology-enabled pathways to increase primary care capacity are:
- To introduce point-of-care technologies that eliminate unnecessary steps and re-work to increase the efficiency of operations.
- To offload selected testing and self-monitoring capabilities to the home or community settings for patient self-management.
To accelerate clinical adoption of POCT in the primary care environment and minimize potential barriers to acceptance, point-of-care technologies should address the following requirements:
- Result Availability: Results must be available during the office visit (typically 10-20 minute result availability) so that decisions can be made in a timely fashion based on the test results.
- Ease-of-Use: Ease-of-use is essential to successful implementation of POCT test devices. In the case of instrumented devices the user interface with the device should be designed to ensure regulatory compliance under the clinical laboratory improvement amendment (CLIA-88) with minimal requirements for intervention by the operator. Results readout must not be subjective but easy to read using color change readout, digital or graphic formats.
- Reducing Operator Errors: The device should have built in software safeguards to ensure proper operation and reduce common errors such as lock-out of untrained operators, lock-out for failed quality control (or failure to perform quality control) and lock-out of expired reagents.
- Sample Types: Samples that do not require a trained phlebotomist should be used such as capillary finger-stick whole blood or saliva.
- Storage of Consumables: All consumables including reagents, calibrators and quality control materials should be able to be stored at room temperature. The shelf life should be minimally 6 months to 1 year.
- Device Footprint: POCT devices should be designed to have as small a footprint as possible. Small bench top or handheld devices are optimal.
- Information Connectivity: All instrumented POCT devices should be capable of being interfaced to the electronic medical record system. The ability to transmit data using a bidirectional wireless interface is most optimal.
- Analytic Performance: As a general rule, the point of care devices should perform equally to central laboratory instruments with regard to analytical accuracy, reportable range and imprecision. Analytical time should be kept to a minimum (less than 5 minutes for common chemistry analytes and less than 15 minutes for immunoassays).
- Cost: Solutions that significantly reduce the cost of testing relative to the existing standard of care are encouraged.
The goal of the Center is the development of integrated systems that address unmet POC testing clinical needs for Sexually Transmitted Disease (STDs). The need to develop acceptable and more easily available POCT for diagnosing sexually transmitted diseases for all high-risk populations is highly significant. These infections are particularly hazardous to women since many, if not most, infections are asymptomatic and only detected through screening or presentation by infected women for testing if they are notified of sexual contacts to infected partners or they perceive themselves at-risk. Five of the top ten reportable diseases to the Centers for Disease Control and Prevention (CDC) in the United States are STDs. Point of Care diagnostics can include tests for rapid diagnosis in the Emergency Department (ED) in which the time from sample to result is four hours or less, diagnostics for rapid diagnosis in a community clinic or non-traditional health care setting in which the time from sample to result is less than one hour and for the home testing market in which the time from sample to result should be less than 15 minutes. There is an additional need for POCT for resource-limited settings, such as developing countries. It should be noted that the user (the person conducting the test) is significantly different in each of these scenarios and may encompass the medical doctor, trained health professional, or lay person with no medical background.
Successful applications will describe the development of tests which minimally:
- can detect less than 5,000 elementary bodies of chlamydia/ml
- are rapid (time from sample to result under 4 hours)
- have low-labor burden for sample preparation and assay, and
- will be low cost (under $30/test).
Multiplex assays which can detect chlamydia as well as other sexually transmitted diseases are encouraged.
You may complete the online survey to "build your own" STD point-of-care test
Cancer care is a continuous process from prevention, screening, diagnosis, and treatment to survivorship. Broad and general barriers to cancer care can be grouped into three categories: patient barriers, provider barriers, and system barriers. Innovative point-of-care (POC) technologies seek to increase the capacity of providers to care for more patients without decreasing the quality of care, increasing burden, or interrupting workflow. POC technologies have the potential to reduce the turnaround time from testing to results and allow for more efficient patient triage, treatment and discharge.
Barriers to utilizing POC tests in clinical settings include patient acceptability, clinician knowledge and acceptance, cost, and technology requirements. Patients and doctors alike may be slow to accept POC testing as a standard of care. Technologies that can increase patient and provider acceptance through innovative plans for test deployment, system integration and education are especially sought.
The Center for Future Technologies in Cancer Care seeks proposals that focus on translational technologies that meet a need in contemporary cancer care. Proposals can focus on needs in the areas of diagnosis or treatment. Diagnosis includes screening and staging of both new and recurrent disease. Treatment can include improved treatment mechanisms (e.g. drug delivery methods), treatment monitoring methods, and/or quality of life interventions for patients in treatment. Applications that address a need in underserved populations will be prioritized.
The POC can be a home, primary care office, clinic, or other location, provided that the technology enables a task to shift from a more to a less sophisticated setting. Cost reduction is one metric on which technologies will be judged, but an increase in positive patient outcomes and/or quality of life should be paramount.
Technologies that are in the basic research stage will not be considered responsive. While clinical data is not required to be competitive, a clear plan toward generating pre-clinical data is required. Projects should be milestone driven, and a statement of how the grant funds would be used to advance the project over the 12 month project period must be given.
We are particularly interested in technologies that address the following needs:
- Tools to monitor treatment toxicities more closely and adjust drug dosing to minimize side effects.
- New materials or drug delivery methods that could reduce or eliminate the need for infusion therapies.
- Tumor “aggressiveness” is currently assessed by histologic grading, staging, and invasiveness based on pathology, scans, molecular testing, etc. We seek POC imaging and/or diagnostic tools to assess these features.
- Tools that address social and behavioral barriers against scheduling, obtaining and discussing results from screening tests.