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MTEC -- Wearable Diagnostic for Detection of COVID-19 Infection
The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) to develop a wearable diagnostic capability for the pre-/very early-symptomatic detection of COVID-19 infection.
Offerors should only propose technology solutions that meet the following two criteria as the following specifications define the minimum prototype requirements that all proposals must demonstrate:
- Currently be at a Technology Readiness Level (TRL) of 3/4 or above [definition of TRL – https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf], and
- Currently be in development or commercially available.
An ideal solution would meet the following capabilities or specifications (not listed in order of importance).
- Platform must be designed for pre-detection (e.g., physiological monitoring of readiness) and early detection of infection and pathogenic response that can be utilized pre-clinically leading to use at Point-of-Need role of care (ROC) 1/2, local doctor’s office, emergency departments, urgent care centers and immediate care clinics.
- The capability should be “wearable”, non- or minimally-invasive and be able to assess physiological markers to monitor the health state of the user. A single device is preferred, but a combination of technologies is acceptable.
- Device(s) should be designed to be worn for continuous physiological monitoring in a non-obtrusive manner and should not affect the daily activity of the wearer. Physiological markers indicative of health state that are of interest to this RPP include, but are not limited to, physiological markers of early COVID symptomology (elevated temperature / fever, respiratory difficulty / cough, etc.), antibodies against COVID 19, and molecular biomarkers indicative of COVID 19 exposure (not all markers are necessary but sufficient markers to provide evidence of COVID exposure are required). Sampling of physiological markers/antibodies/biomarkers can occur “on demand” to conserve power. Device should be worn until exposure has been verified or until a medical professional has deemed the device is no longer needed.
- Results should be easy to interpret by non-laboratory personnel and results should be collected and able to be saved and shared in a standard and secure (maintain HIPPA) format.
- The device must be able to be stored and operated between 4°C to 45°C.
- Physiologic surveillance for COVID-19 positive individuals that do not yet show clear medical symptoms is an ultimate goal. Physiological signatures therefore must produce predictive algorithms that can be tied into validated and relevant antibody/molecular measurements.
- Offeror must have an established manufacturing capability for the platform and assay kits on a large-scale.
Enhanced White Papers are due no later than May 13 at 12:00pm Eastern Time. Due to the critical and urgent nature of the technical topic area, MTEC membership is NOT required for the submission of an Enhanced White Paper in response to this MTEC RPP. However, membership will be required for Offerors recommended for award. For information on how to join MTEC, please visit http://mtec-sc.org/how-to-join/