Administration of Programs FY 24-25: MidSouth Hub: Concentration, Extraction, and Identification Device (CEID) for Detection of Pathogens in Environmental Samples

Grants and Contracts Details

Description

Technical Development activities: Technical Activity 1: Finalize cartridge prototype. The current prototype of the extraction cartridge is operational for detecting SARS-CoV-2 in wastewater samples. However, we need to lock the product design for optimized small-scale (100-200 units) manufacturing processes that can facilitate further pilot testing of 10 units per week. - Milestone 1: Develop a quality control protocol to ensure consistent fabrication tolerances and cartridge performance output. We aim to achieve <5% manufacturing tolerances using laser cutting the cartridges, and <10% for pathogen capture and identification using standard controls. - Milestone 2: Test cartridge prototype with various wastewater samples. Initial testing of the prototype has been successful for two wastewater sample locations. We are aiming to validate the performance of the device with a variety of wastewater samples from different WWTPs. We compare the cartridge performance with our standard extraction and amplification method (qPCR) and we aim to achieve a minimum of 75% sensitivity and specificity. Technical Activity 2: Expand the assay menu. While testing for SARS-CoV-2 is going to be our leading assay, we are going to expand our assay to other respiratory infectious diseases (e.g., Flu A/B, RSV). - Milestone 1: Develop an assay menu for the cartridge. While the system is designed to incorporate assays for any given pathogen, we initially aim to expand to Flu A/B and RSV assays which are among the top priorities according to our initial market research. We are going to develop and characterize RT-LAMP assays for those pathogens with a minimum limit of detection of 50 cp/rxn. - Milestone 2: Demonstrate the proof of concept for a “multi-target” cartridge. The cartridge can accommodate multiple separate RT-LAMP reactions, so we will test spiked samples for SARS-CoV-2, Flu A/B, and RSV on the same cartridge. We will compare the on-chip LAMP result for each pathogen with the corresponding RT-PCR assay. The aim is to achieve >0.9 R-squared value for the correlation of each pathogen LAMP assay with the corresponding RT-PCR results. Technical Activity 3: Develop the “breadboard” for the automated device to run the cartridges. We have the preliminary design for the automated system which contains the linear actuator, power source, heat pad, thermocouple, microcontroller, cartridge stage, and light source. The goal is to develop a prototype that can automatically run single cartridges. - Milestone 1: Assemble the linear actuator unit. The magnet collects beads in the sample well and moves them through the oil barriers and wash buffers. In the automated system, this is facilitated by a linear actuator that is controlled by an Arduino. The goal is to collect and move >90% of the total bead mass to the last well of the cartridge. - Milestone 2: Incorporate the temperature control unit. For the elution step and the LAMP reaction, the system needs a 65C heat source, and corresponding thermometer, and a cooling system. We aim to achieve the desired temperature (+/-1%) and integrate the temperature control unit with the remainder of the instrument. Pivot points: 1- The technical milestones go/no-go criteria might need to be adjusted based on the customer needs identified in the customer discovery. 2- The assay menu may change based on the clinical importance and burden of a specific pathogen identified in the voice of customer analysis. 3- LAMP assays are easy to use and do not need complex equipment to run. However, there are some other competing alternatives such as recombinase polymerase amplification (RPA) and CRISPR-Cas techniques. We might need to transition to other amplification methods if that is determined to be a preferable option by the customers. Commercialization activities: Commercialization Activity 1: Develop IP strategy. - Milestone 1: Apply for (provisional/full) patents. We have submitted two related IP disclosures (see intellectual property section for more details) to UKY’s Office of Technology Commercialization (OTC). We aim to pursue patenting those technologies. - Milestone 2: Finalize sub-licensing agreement. As described in the “intellectual property” section, we need to achieve a sub-licensing agreement with Salus Discovery LLC to use the IFAST technology for environmental monitoring. While we already have an agreement to negotiate in good faith (see Letter of Support from Salus Discovery, LLC), we need to specify the details for a legal agreement, and we seek further assistance from UK’s OTC and legal team. Commercialization Activity 2: Voice of customer analysis. While we have done preliminary market research on WBE technologies, we need to iterate the voice of customer analysis and conduct interviews with end users and customers (actual payers) to refine our propositions. - Milestone 1: Conduct interviews with different stakeholders. We aim to conduct as many interviews (minimum of 4/month) as possible with the appropriate personnel in the following entities to gauge their interest and pain points in using the proposed technology. Examples: CDC, local Department of Public Health, WWTPs, EMS, citizen scientists, and competitors (e.g., Biobot, LuminUltra). - Milestone 2: Complete UK UAccel/ICORPS Fall 2024. We like to maximize our efforts to know more about our market and customer segments and we plan to apply and participate in those programs offered in Fall 2024. Commercialization Activity 3: Prepare for a FastTrack SBIR (Phases 1 and 2 together). We anticipate that the Midsouth REACH funding will enable us to prepare a competitive SBIR FastTrack application by the end of the Midsouth REACH funding cycle(s). - Milestone 1: Refine the business model. We aim to have a draft of a viable business model that serves the customers’ needs identified in our customer discovery and provides a sustainable revenue stream. - Milestone 2: Identify further R&D activities. - Milestone 3: Company formation.
StatusActive
Effective start/end date10/15/244/30/25

Funding

  • University of Louisville: $16,734.00

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