Advanced Wearable Alcohol Real-time Ethanol Sensor (AWARES)

Overview

The Rapid Acceleration of Diagnostics (RADx®) Coordination Center at Cimit, on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Minority Health and Health Disparities (NIMHD), and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH), announces the Advanced Wearable Alcohol Real-time Ethanol Sensor (AWARES) Funnel. This initiative aims to accelerate the development of non-invasive, inconspicuous, wearable alcohol biosensors capable of continuously detecting blood alcohol concentration (BAC) with high accuracy and high resolution in real time, and with personal attribution and calibration. These next-generation alcohol biosensors may also include multiplexed or multimodal measurement of additional analytes and physiological signals. The wearable must leverage cutting-edge biosensing technologies, such as advanced near-infrared biosensing, or innovatively adapt or optimize existing technologies to transform non-invasive biosensing of BAC. Technologies that detect alcohol in breath or sweat are outside the scope of this initiative.

The AWARES Funnel consists of three phases offering total awards of $1,700,000, along with technical, clinical, and commercialization support to maximally accelerate progress. Only eligible proposals that include all submission elements outlined in the solicitation will be reviewed. A limited number of top performers will receive awards and advance to further phases of the program. Based on performance of the AWARES program, NIH will consider committing future resources for the next stage of AWARES supporting human testing and market readiness.

Potential applicants are highly encouraged to fully read the solicitation and associated FAQs for additional information.

Background

Non-invasive wearable alcohol biosensors that allow passive tracking of BAC in real time in naturalistic environments provide an opportunity to accurately monitor alcohol consumption and drinking patterns for public health and consumer wellness applications, including early detection and prevention of alcohol misuse, treatment monitoring, relapse prevention, and management of alcohol-related chronic conditions. Current wearable alcohol biosensors are limited by insufficient sensitivity and accuracy, delayed measurement, inadequate accounting for interindividual variability, obtrusive designs, limited tamper resistance, and lack of personalized calibration. These limitations and challenges call for technology innovation to develop noninvasive wearable alcohol biosensors that detect BAC in real time with high accuracy. Recent breakthroughs in non-invasive biosensing technologies, combined with Super Intelligence (SI) analytics, offer an opportunity to overcome critical challenges and accelerate the development of wearable non-invasive alcohol biosensors capable of accurately monitoring BAC in real time, supporting user authentication, and enabling other critical features.  

The overall goal of the Advanced Wearable Alcohol Real-time Ethanol Sensor (AWARES) Funnel is to accelerate the development of innovative, non-invasive, wearable alcohol biosensing technologies that accurately track BAC in real time, with greater sensitivity and accuracy than current technologies, possibly with potential extension to multiplexing capabilities to monitor additional analytes and/or physiological signals.

Program Description

AWARES Funnel activities will accelerate the development of innovative, non-invasive wearable real-time alcohol biosensors, with the goal of achieving design lock. The wearable technology must leverage cutting-edge biosensing technologies, such as advanced near-infrared biosensing, or innovatively adapt or optimize existing sensors to address current limitations and transform non-invasive biosensing of BAC in real time. The wearable biosensor should integrate advanced SI analytics with secure, privacy-protected data access. Technologies that detect alcohol in breath or sweat are outside the scope of this initiative and will be considered non-responsive. The final wearable technology can be a smartwatch-like or other unobtrusive wearable with the required features and analytical parameters.

The AWARES Funnel outcome is intended to accelerate towards commercialization, broad adoption, and real-world deployment of advanced non-invasive alcohol biosensing technologies. The resulting devices will enable a wide range of applications requiring alcohol-consumption monitoring, while advancing personalized care and strengthening tools for monitoring treatment response, recovery, relapse, and prevention.

Solicitation Requirements

AWARES will only consider non-invasive monitoring technologies that enable direct or indirect measurement of BAC. Technologies that require invasive sample collection, or those that detect alcohol in breath or sweat, will be considered non-responsive. Multiplexed or multimodal measurement of other analytes and/or physiologic parameters, in addition to alcohol, is encouraged but not required. A working prototype/breadboard or, at minimum, proof-of-concept data supported by bench and/or in vivo testing that demonstrates the technology can measure BAC non-invasively with high accuracy and specificity is required for submission.

Analytical performance and design features of the non-invasive wearable alcohol biosensor include:

• Consistent performance with high sensitivity and specificity, with a dynamic range of detection spanning 0.02% – 0.3% BAC.
• Ability to analyze alcohol and, where applicable, other analyte concentrations in real time, continuously for 24 hours or longer, and with a minimum 5-minute sampling rate.
• Device baseline calibration and individualized SI-based calibration by integrating personalized biometrics measurements for user identification.
• Reliable operation suitable for all skin tones and body types.
• Water-resistance, tamper resistance, and malfunction detection and notification.
• A rechargeable power source that operates for more than 24 hours, preferably lasting 2 -3 days on a single charge, and provides sufficient power for both biosensor operation and analytical performance.
• Remote data access with data security and privacy protection strategies, as well as, flexible data connectivity to support clinical research or digital health platform integration.

Program Structure

AWARES is a three-phase RADx® Innovation Funnel designed to accelerate non-invasive alcohol biosensing technologies with milestone-based funding and a Deep Dive assessment to rapidly de-risk technologies toward design lock. In addition to financial incentives, developers receive support from subject matter experts to help address scientific/technical, clinical, and commercialization requirements.

Phase 1 – Submission: Project proposals will be accepted and reviewed via Cimit’s online system. Innovators can access the online portal here.

Innovators must submit proposals describing a non-invasive alcohol biosensing prototype technology, or at minimum, proof-of-concept data, along with development plans, milestones, deliverables, and clear go/no-go criteria. Only eligible proposals that include all required submission elements will be reviewed. Up to five projects may be selected to receive an award in Phase 1.

Phase 2 – Deep Dive: Innovators selected in Phase 1 will participate in a Deep Dive process. A RADx® team with healthcare and commercialization expertise will directly engage with each innovator to assess the proposed technology, identify key development risks, establish mitigation strategies, and prepare a development plan for Phase 3. Depending on the technology’s maturity level, this process could take from a few days to a few weeks. Up to three projects may be selected to receive an award and advance to Phase 3.

Phase 3 – Technology Development: Phase 3 will support innovators in rapidly advancing their technology toward design lock over 8 -10 months. The RADx® team and subject matter experts will continue working with each innovator to mitigate the risks and execute the development plan in Phase 2. At the end of Phase 3, up to two final winners, possibly designated first and second place, may receive an award.

Judging and Criteria

Phase 1: Submission

Submissions from innovators received in advance of the submission deadline will first undergo an administrative triage step to review innovator eligibility as well as submission completeness and applicability of scope. Eligible submissions will then be evaluated by an Evaluation Panel composed of scientific/technological, clinical, and commercialization experts using the Evaluation Criteria listed below. The Evaluation Panel will provide go/no-go recommendations to the NIH Judging Panel regarding which submissions should be selected as advancing from Phase 1 to Phase 2.

The NIH Judging Panel, composed of federal employees, will review these recommendations and select the award winners. Only innovators selected as Phase 1 winners will advance to Phase 2 of the Funnel. NIH does not intend to provide innovators with individual reviews or summaries of reviewer feedback in this or any subsequent phases of the Funnel.

Phase 1: Evaluation Criteria
Scientific/Technological

• Does the submission sufficiently describe the biological, chemical, and/or physical principles of the non-invasive biosensing technology, as well as its mechanisms of detection, data collection, personalized biometrics, tamper detection, analysis, and reporting of results?
• To what extent has the technology demonstrated high accuracy relative to a reference standard, along with a strong limit of detection and resolution, for tracking BAC in real time?
• Does the submission provide sufficient feasibility data and other evidence to demonstrate proof of concept for the technology?
• To what degree can the proposed biosensing technology be effectively integrated with a digital health platform to facilitate clinical research and health care programs?
• Are the proposed milestones and deliverables feasible within the proposed timeframe of Phase 3 – Technology Development and closely aligned with the goals of this Funnel?

Clinical and Non-Clinical Applications

• What is the likelihood that the technology, if successful, will improve quantification and real-time tracking alcohol consumption over retrospective data collection and inform individual drinking behavior in alcohol research and treatment?
• Can the technology be efficiently integrated into the intended clinical and healthcare environments and processes (i.e., easily used by researchers or healthcare professionals), or can it provide novel approaches to enhance current translational research or trials?
• How does the technology advance personalized care and strengthen tools for naturalistic monitoring of drinking patterns, recovery, relapse, prevention, and intervention?

Commercialization

• Does the proposed technology have a realistic pathway to commercialization, and what are the key risk factors that must be mitigated to make this a viable product?
• Are the plans to conduct human testing and validation feasible and appropriate?
• Does the submission propose realistic milestones/activities to achieve the stated goals?

Innovation

• Does the technology represent a scientific or technical approach that is novel, unique, and/or a significant advancement over the current non-invasive alcohol sensing technologies?
• If applicable, does it represent the innovative adaptation of existing biosensing technologies that non-invasively measure other analytes in vivo? Can it support interoperability or be extended to multiplex additional analyte(s) and/or physiological signals? Does it use multiplex or multimodal approach to determine BAC with high accuracy? 
• How are aspects of SI advantageous to the full solution?
• How effective is biometric authentication at accurately identifying the authorized user? How tamper-resistant is the device against removal and transfer between users, and what mechanisms ensure continuous verification that it remains on the original, authorized user?

Team

• Do the team members have sufficient scientific and technological expertise, including expertise in biosensing technology and alcohol biochemistry and physiology in humans? 
• To what extent does the team possess the necessary expertise, experience (i.e., successful product launches), and resources to advance the proposed non-invasive alcohol biosensing technology and attract additional investments from industry partners, investors, and/or the government? 

Phase 2: Deep Dive

Phase 1 winners will work closely with a RADx® team with healthcare and commercialization expertise who will further assess each proposal against the evaluation criteria above, identify key development risks and mitigation strategies, and refine the development plan for Phase 3. The results of this Deep Dive will be presented by the RADx® mentor to an Evaluation Panel composed of scientific/technical, clinical, and commercialization experts.

The Evaluation Panel will assess:

• the merits of science and technology
• alignment of solicitation requirements
• level of innovation
• commercialization potential
• innovator team expertise
• risk profile and adequacy of risk mitigation
• appropriateness of the development plan

The Evaluation Panel will provide go/no-go recommendations to the NIH Judging Panel regarding which submissions should be selected as Phase 2 winners and should advance to Phase 3. The NIH Judging Panel will review these recommendations and select the winners. Up to three innovators selected as winners of Phase 2 will receive an award and advance to Phase 3 of the Funnel.

Phase 3: Technology Development

The primary goal of Phase 3 is to accelerate and support innovators as they advance their non-invasive wearable alcohol biosensors toward design lock. The specific timing, requirements, and evaluation criteria for Phase 3 awards will be announced before this Phase and will be determined based on the portfolio of technologies that have received Phase 2 awards, their stage of development, and the work required to successfully de-risk those projects. However, innovators can anticipate being assessed on the extent to which they have provided objective evidence of risk mitigation, advancement in technology maturation, and further refinement of human testing, and commercialization strategies, among other criteria.

To achieve the objectives of the AWARES Funnel, it is critical that each innovator actively engages with their RADx® team and participates in relevant programmatic activities in an open and transparent manner. Therefore, innovators will also be evaluated based on their level of communication and cooperation with their RADx® mentor, AWARES Program Managers, and NIH staff, as well as their provision of pertinent information necessary to assess progress. 

Awards

The total award pool for this Funnel is $1,700,000. Awards will be disbursed after the successful completion of each phase in the following amounts:

• Phase 1: $10,000 per winner; up to 5 winners could be selected to advance to Phase 2
• Phase 2: $300,000 per winner; up to 3 winners could be selected to advance to Phase 3
• Phase 3: 1st place = $500,000, 2nd place = $250,000

Unawarded funds remaining after the selection of award recipients for a given phase may be rolled over into a subsequent phase and added to the awards for that phase; however, NIH has sole discretion to increase any individual award above the amount outlined above.

In addition to the awards listed above, innovators receive comprehensive support from a RADx® team and SMEs throughout their participation in the Funnel. Support may include:

• Access to subject matter experts for feedback on technology development, scientific rigor, and feasibility.
• Mentoring on manufacturing and supply chain considerations
• Mentoring on business strategy, market entry, and sustainability.
• Regulatory guidance to understand and/or plan for regulatory submission.
• Reimbursement guidance on understanding reimbursement implications.

Award Payment: Awards under this Funnel will be paid through the RADx® Award Management Center under contract to NIH. Awards will be issued by electronic funds transfer and in compliance with an agreement negotiated with the Award Management Center prior to beginning work.

NIH reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Funnel, or any part of it, for any reason, and/or (b) not make an award if no submissions are deemed worthy.

Timeline

• Funnel Launch: November 12, 2026
• Submission Deadline: January 20, 2027
• Phase 1:
  • Judging Period: February 2027
  • Winners Announced: February 15, 2027 (anticipated)
• Phase 2:
  • Deep Dive Engagement: February/March 2027
  • Judging Period: March 2027
  • Winners Announced: April 5, 2027 (anticipated)
• Phase 3:
  • Technology Development Begins: April 2027
  • Final Judging Period: January 2028
  • Final Winners Announced: February 1, 2028 (anticipated)

Eligibility Rules

To be eligible for an award under this Funnel, an applicant (whether a Team or Entity) must be US-based. Eligible applicants include individual innovators, teams, small or mid-size businesses, large industry enterprises, non-profit organizations, and research institutions, across all sectors. The applicant must:

1. Comply with all requirements set forth in this announcement.
2. Applicants must have a place of business located in the United States, which operates primarily within the United States, or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor. Organizations should be more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States.
3. Only a Team Captain who is a U.S. citizen or permanent resident, or a U.S.-based Entity, can receive an award.
4. Not be a federal entity or federal employee acting within the scope of their employment.
5. Not be an employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity.
6. Not be debarred, suspended, or otherwise excluded from participating in or receiving awards from NIH. Eligibility will be verified through SAM.gov, and NIH reserves the right to rescind any award made to an excluded party.

How to Submit

The official announcement for the RADx® AWARES Funnel can be found on cimit.org/awares. The registration and submission portal is administered by the RADx® Coordination Center operating under a contract with the National Institutes of Health (NIH). Any questions should be sent to CimitCommunications@partners.org.

Innovators will respond to a series of prompts across several topic areas, including technology design and performance, overview of the innovator and environment, anticipated impact of the technology, and plans for continued development. In brief, innovators will be asked to provide:

• Proof-of-concept data demonstrates the feasibility of the innovative technology, or adaptation of existing technology, for non-invasive detection of blood alcohol levels directly or indirectly in real-time.
• A description of the current level of technology maturity and available evidence from prototype devices or benchtop data.
• Details on how the technology will meet the requirements for analytical performance and design features of the desired non-invasive wearable alcohol biosensor.
• Preliminary data demonstrating alcohol detection, supporting the validity of the proposed alcohol measurement approach.
• Plans for continued technology development, including proposed Phase 3 milestones and deliverables, a strategy for human testing, and strategies to advance the technology towards the market.

All submission content must be provided in English and must adhere to any length requirements specified in the submission portal.

Do not include proprietary or confidential information in the title, abstract, or summary sections, as they may be publicly shared if the innovator is selected to receive an award across in any phase of this Funnel.

Innovators must complete their submission and provide all of the requested information in the portal no later than January 20, 2027. Innovators who do not submit their complete submission to the portal by this deadline will not have their submission considered.

Additional Information

All interested parties are encouraged to thoroughly review this solicitation and the information provided on the Frequently Asked Questions page.

For other programmatic or technical questions please contact RADxNIBIB@mail.nih.gov. For all emails, in the subject line include: Inquiry about AWARES Funnel.