WE-REACH•RADx Opportunity Information
A special WE-REACH•RADx funding opportunity under the NIH’s RADx-Rad Covid-19 initiative: “Novel Biosensing Technologies for Screening, Diagnosis, and Monitoring of COVID-19 from Skin and the Oral Cavity”.
OVERVIEW
The Washington Entrepreneurial Research Evaluation & Commercialization Hub (WE-REACH) provides training and project funding for life-science innovators and entrepreneurs. Newly announced awards will be made as a part of the NIH’s Rapid Acceleration of Diagnostics-Radical (RADx-Rad) funding opportunity specifically allocated for the five REACH hubs in the US, including the Pacific Northwest’s WE-REACH. Successful projects will be supported with activity-based and milestone-driven funding and project support to accelerate the development of innovative and impactful COVID-19 diagnostic products.
WE-REACH•RADx funding is a one-time opportunity for institutional researchers to advance product concept development (R&D) of novel, safe, and effective biosensing technologies that target skin or the oral cavity as sampling sites. This funding is not for discovery research or for identification of new biomarkers. Skin biosensing designs must target detection of volatile organic compounds (VOCs, i.e. scents or odors) emanating from skin in passive and noninvasive manner for use at point of care. In addition to VOCs, oral biosensing technologies may target a wealth of biological, chemical and physical biosignatures representative of SARS-CoV-2 virus and/or COVID-19 disease sampled from exhaled breath/droplets, saliva, and tissues in the oral cavity using a variety of detection schemes.
A total of 5-10 projects will be selected from all of the five national REACH Hubs, including WE-REACH. Each RADx-Rad project funded through WE-REACH may request up to $434,000 for a 2-year plan. It is expected that projects funded through REACH will clearly demonstrate early feasibility of proposed R&D to position the projects for competitive and direct-to-phase II SBIR/STTR funding or other sustainable support for product development in the future.
PURPOSE
The NIH has issued Rapid Acceleration of Diagnostics (RADx) in response to the declared public health emergency issued by the Secretary of the Department of Health and Human Services (DHHS) for the 2019 Novel Coronavirus (COVID-19). The Rapid Acceleration of Diagnostics-Radical (RADx-Rad) is one of four RADx emergency initiatives providing an expedited funding mechanism. The goal of RADx-Rad is to solicit proposals for the development of novel, nontraditional approaches to identify the current SARS-CoV-2 virus (or other markers of the COVID-19 disease) that can be used in future outbreaks of COVID-19 or for other, as yet unknown, viruses. In early August, seven RADx-Rad Funding Opportunity Announcements (FOAs) were published. Three of the FOAs in the RADx-rad initiative aim to support the development of “Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 from Skin and the Oral Cavity”**. These FOAs issued as RFAs in Grants.gov from the PHS/NIH solicit applications for the development of novel biosensing technologies that leverage the accessibility of human skin and the oral cavity for detection of biological, chemical, and other biometric signatures of COVID-19.
NIH requires that all projects funded under this opportunity will actively coordinate, collaborate, and share data with the RADx-Rad Data Coordinating Center, as allowed, and with considerations under tribal IRB processes, as appropriate. Researchers applying to this funding opportunity are strongly encouraged to review the Data Coordinating Center (DCC) funding opportunity (RFA-OD-20-019). Projects that do not have an infrastructure to rapidly report study findings and impact to the DCC will not be reviewed.
The current WE-REACH•RADx biosensing initiative is an extension of the above mentioned NIH RFA in that WE-REACH intends to support early stage R&D (as opposed to the NIH RFAs’s focus on product development or D) projects on an accelerated path toward proving concepts that merit further development as products. Thus, as a part of the National REACH Network, the objective of WE-REACH is to advance early technological Feasibility to the Proof-of-Product Concept stage.
(**RADx-RAD FOA— https://www.nih.gov/research-training/medical-research-initiatives/radx/funding#radx-rad)
SPECIFIC OBJECTIVES
Biosensing and detection technologies submitted to this initiative should provide reliable associations between biomarkers emanating from skin or the oral cavity to patients with symptomatic and asymptomatic COVID-19. Leveraging the accessibility of human skin and the oral cavity, the NIH seeks (1) to advance novel biosensing technologies that are innovative, safe, and effective, and (2) to implement such technologies into devices with integrated artificial intelligent (AI) systems for the detection, diagnosis, prediction, prognosis and monitoring of COVID-19 in clinical, community and everyday settings.
To this end, dedicated engineering and artificial intelligence systems may be required. For skin monitoring, the device can include Electronic-nose (E-nose) technology or Gas Chromatography (GC). Thus, biosensing technologies targeting VOCs emanating from skin or the oral cavity will be referred to as SCENT (Screening for COVID-19 by E-Nose Technology). Oral biosensing devices may consist of technologies that are thoroughly characterized as safe and effective in preclinical studies to conform to and perform in the oral cavity. Non-invasive, real-time, continuous or periodic measurements of VOCs and other biomarkers in breath, droplets, tissues and other samples emanating from the oral cavity as signatures of onset, progression, and resolution of COVID-19 are desirable.
Multidisciplinary collaborations are expected to ensure project success. Disciplines may include: Biomedical engineers, material scientists, biosensing experts, software engineers, chemists, dentists, clinicians, virologists, clinical scientists, biostatisticians, data analysts and other relevant experts in academia and industry.
APPLICATION TIMELINE
| Activities | Key Dates |
| Submit WE-REACH•RADx Pre-Application | Wednesday, September 9, 2020 (5:00pm) |
| Invitations Sent to Selected Teams to Submit a Full Application | Tuesday, September 15, 2020 |
| Invited Full Applications Due | Monday, October 19, 2020 (5:00pm) |
| Award Funding Decision | December, 2020 |
| Milestone and Activity-Based Budget Development, Review, and Approval | December 2020/January 2021 |
| WE-REACH•RADx Awardees Announced with Earliest Start Date | January 2021 |
For more information, please contact the WE-REACH Administrator at wereach@uw.edu.
Or visit our website: https://www.washington.edu/we-reach/funding_resources/