HHS SBIR RFA-HL-14-011

Purpose/Research Objectives

The purpose of this Funding Opportunity Announcement (FOA) is to support research using advanced technologies (e.g., bio-chips, microfluidics, and mobile technologies) to develop novel point-of-care (POC) devices and implement existing technologies in clinical settings with a goal to guide diagnostic and therapeutic efforts for the heart, lung, blood and sleep disorders.  Applicants are encouraged to form a multidisciplinary team/network (i.e., from technical to clinical expertise) to develop devices that will significantly empower patients, physicians, and clinical researchers to better manage or treat HLB and sleep disorders.  

Applicants should describe technical approaches, methodologies, and plan to develop and implement their POC devices that will significantly improve disease management and/or treatment.  Applications should have all relevant details including quality control and assurance, standards for samples, handling, and testing.  Related previous experience and qualifications of the team members should be well described.  Once the POC tool/technology/test has been developed and validated, applicants will be expected to test the feasibility of the product in ongoing (or otherwise) heart, lung, blood and sleep clinical studies.  Applications may also need to describe how to interpret the testing results as well as relevant bioinformatics and/or wireless technological component to link the POC test data with other relevant patient data (e.g., data in Electronic Health Records). This will enable the rapid sharing and synchronization of data for treatment at the POC.  It is expected that commercial products or tools will be developed for use in the clinical setting at the POC as a result of this program. 

POC technologies are becoming increasingly valuable tools in improving or enhancing the diagnosis of several conditions including congestive heart failure, acute coronary syndrome, coagulopathy and asthma.  Major benefits such as faster time to intervention have been demonstrated when the results of POC testing are utilized in conjunction with Electronic Health Records or mobile technology, and when combined with goal directed therapy.   Utilization of POC technology allows for:

• Greater accessibility to novel technologies for disease diagnosis.
• Real-time detection of clinical laboratory measures/biomarkers.
• Standardization of phenotype measurements.
• Rapid, standardized, and cost-effective diagnosis.
• Improved assay/test throughput, decreased assay turn-around times.
• Decreased delays in initiation of therapy.
• Enhanced communication of test results with multiple parties.

Based on the benefits listed above, these technologies have the potential to play a pivotal role in personalizing medicine, improving healthcare delivery, and, ultimately, reducing healthcare costs.  While many of these tools are being developed for clinical application, it is also possible that some of the existing technology could enhance the research enterprise by being used “onsite” for clinical research and trials. Additional benefits of POC-related tools and technologies in clinical research include: easier recruitment, baseline, and follow-up measurements, expedited patient ascertainment and analysis, more rapid dispensation of interventions, better quality control and monitoring of study compliance.  Utilization of POC technology could also allow for research participants to be enrolled in less sophisticated research environments and remote, low-resource locations. 

Specific Areas of Research Interest:

Projects that address a specific and well-characterized clinical need will be considered of high potential impact.  The technologies developed with funding through this FOA are expected to be integrated systems or, if they are novel components, be easily integrated into existing systems.  Proposed tools or technologies should interoperate and communicate with existing health information technology systems as appropriate.  Some other technical features that are expected are the following: reliability, robustness, safety, simplicity, reliance on the appropriate baseline information, contextual awareness, inclusion of software to support decision-making, and consideration of power consumption.  Ideally, systems will integrate information from multiple sensors, appropriate clinical information, and ambient data such as temperature or global position.  Proposed tools and technologies should incorporate existing standards and consider regulatory requirements where appropriate.  In addition, global health concerns, improved access to underserved areas, and cost-effectiveness should be highlighted.

Research examples include, but are not limited to:

• A nano-sensor or bio-chip device to determine nutritional indices from blood and urine samples at the POC.
• POC device to monitor complicated and vulnerable patients after heart or lung transplant.
• A portable bio-chip device for DNA extraction and high-throughput genomic analyses, for genotype-guided clinical heart, lung or blood treatment studies.
• POC ultrasound device to detect aortic aneurysms.
• Improved microfluidics assays and POC EKGs to detect myocardial infarction.
• Implementation of simple, robust, and cost effective methods to measure and transmit blood pressure and/or cardiovascular function information from remote locations, e.g., test reliability/clinical utility of an existing blood pressure measuring smart phone application.
• POC instruments to detect stage of bleeding in trauma patients; determine responsiveness to antiplatelet therapies; assess need for platelet or plasma transfusion.
• Evaluation of sensor devices capable of detecting hemoglobin levels to inform therapeutic decisions in clinical trials evaluating populations suffering acute blood loss or hemolysis (trauma, postpartum hemorrhage, anemias of any type).
• POC devices to measure and transmit information about the quality of patients’ environment, e.g., air quality/pollution.
• Mobile apps to alert and monitor asthma treatment that can be used by both patients and doctors.
• Portable and cost-effective POC device(s) to alert/monitor sleepiness of drivers while driving and/or the sleep quality during night; assess samples for biomarkers that will facilitate the characterization of an individual’s chronotype, variations in chronotype, and the effect of medical interventions on circadian rhythm.
• Affordable in home monitoring devices to assess trans-dermal oxygen saturation via mobile apps that could also capture heart rate, respiratory rate, and temperature.
• Inexpensive implantable (injectable) nanochips for POC or in home monitoring of drug levels e.g. antibiotics, TB drugs, anti-retroviral drugs, Coumadin, corticosteroids.
• Portable, manually powered nebulizer device that is cost effective and easy to use by patients.
• Breath Test device to monitor or diagnose heart, lung, or blood disorders.
• Novel sputum test device to monitor or diagnose lung diseases.

Applicants are encouraged to collaborate with federally funded programs such as the NCATS Clinical and Translational Science Awards (CTSAs), the NIBIB Point-of-Care Technologies Network (POCTRN), the NICHD Medical Rehabilitation Research Infrastructure Network, the NIH Basic and Behavioral & Social Science Opportunity Network (OppNet), the NIH National Centers for Biomedical Computing (NCBC), the Agency for Healthcare Research and Quality (AHRQ) Practice Based Research Networks (PBRNs), the AHRQ Patient Safety Network (PSNet), the AHRQ Evidence-based Practice Centers (EPC), and the AHRQ Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network. If collaborating with such a program, applicants should describe how the collaboration would enhance performance and productivity to explore, develop, and integrate tools and technologies for supporting clinical trials.  Applicants are advised to provide a letter of agreement that identifies the level of support from the Principal Investigator or Program Director of those centers.