Lateral Flow Assay (LFA) validation and manufacturing

The following is a Sources Sought Notice. The Government is seeking to identify qualified sources under North American Industry Classification System (NAICS) 334516 - Analytical Laboratory Instrument Manufacturing. This Sources Sought Notice is for market research information only and is to be used for preliminary planning purposes. No proposals are being requested and none will be accepted in response to this notice. THIS IS NOT A SOLICITATION FOR PROPOSALS, AND NO CONTRACT WILL BE AWARDED FROM THIS NOTICE, nor does it restrict the Government as to the ultimate acquisition approach. The Centers for Disease Control and Prevention's (CDC) Laboratory Branch seeks an established medical device company with the proven capabilities and expertise required to manufacture and validate the performance of lateral flow devices. Commercial medical device companies are sought with demonstrated success in producing large-scale lateral flow kits under good manufacturing practices to produce kits containing lateral flow assays with associated buffers, lancets, and instructions. A Contractor will manufacture 25,000 lateral flow devices to be used in pre-clinical and clinical studies evaluating their performance and utility in rapidly diagnosing HIV antiretroviral usage in point-of-care facilities. The Government will provide the technical design and the Contractor will need to adapt the design to its production pipeline to produce tests that meet the optimal test design specifications. The Contractor will optimize the test performance in their production system and provide the Government with 100 prototype tests for validation prior to selection of the final design for large-scale production. The Contractor may need to perform multiple rounds of optimization to achieve required test performance. The Contractor will perform an assessment of shelf-life for the finalized lateral flow kit. After Government's validation and acceptance, the Contractor will produce kits containing 25,000 lateral flow assays with associated buffers, lancets, and instructions. The Contractor will consult with the Government during the contract period. Optimization and production will occur at the Contractor's facility. Background: The second and third pillars of Ending the HIV Epidemic in the US (EHE) initiative is to increase the number of persons prescribed pre-exposure prophylaxis (PrEP) who are at increased risk for HIV, and, if living with HIV, initiate and maintain therapy. However, achieving and maintaining specific levels of antiretroviral drugs (ARVs) is necessary for both prevention of infection and suppression of HIV, if already infected. Rapid and inexpensive assays to measure drug levels are a crucial tool that can inform decisions by patients and providers on treatment and behavior. The potential benefit of simple, rapid assays that can detect ARV levels at the engagement visit and with self-use on encouraging adherence to ARVs requires evaluation. Such tests can furthermore have a diagnostic benefit when evaluating clinical outcomes and elucidating the cause of confounding test results. The in-house development of antibodies that are highly specific for ARVs has allowed the development of lateral flow devices that provide accurate and rapid determination of drug levels in people on PrEP and HIV patients. The purpose of this Sources Sought Notice is to obtain insight into the interest, capabilities, and qualifications of small business firms; as well as assist the Government in preparing market research and establishing an acquisition strategy in support of this effort. As part of our market research efforts associated with this acquisition and is considering various acquisition strategies to deliver this project and requests input from industry. The following information is requested in this Sources Sought Notice with a limit of eight (8) pages for your response: 1. Organization name, address, email address, website address, point of contact, telephone number, and business size (e.g. small business, 8(a), HUBZone, SDVOSB, WOSB, VOSB, other) and type of ownership for the organization; include Unique Entity ID number and CAGE code. 2. Provide a description of your firm's interest in providing a proposal for the work described above. Please provide at least two (2) recent relevant/comparable manufacturing projects performed within the past three (3) years (no more than two pages per project). For each project provided it is recommended to include: a brief description of the project and how it is comparable to the work required for this project, customer name and contact information, customer satisfaction, contract type (e.g., Firm Fixed Price, Fixed Price Incentive, Cost Plus Fixed Fee, etc.), and dollar value of each project. 3. Provide your firm's capabilities/availabilities in performing the design, optimization, and validation of lateral flow assays (LFA) to detect HIV integrase inhibitors in blood. The contractor will provide (1) records of all experiments performed to adapt the LFA design to their equipment, (2) slide decks of technical presentations, (3) a design history file with all materials associated with the adaptation, validation, and stability testing of the LFAs, (4) pilot lots of lateral flow devices for validation, and (5) 25,000 lateral flow devices with necessary buffers, lancets, and instructions in kits. Please send your responses via email to mag8@cdc.gov no later than 1/31/2025 at 12:00 p.m. EST. This Sources Sought Notice is for market research purposes only and IS NOT A REQUEST FOR PROPOSAL nor does it restrict the Government as to the ultimate acquisition approach. The Government will not reimburse respondents for any costs incurred in preparation of a response to this notice.