Lateral Flow Assay (LFA) validation and manufacturing
ID: HCKBG-2025-00447Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFCENTERS FOR DISEASE CONTROL AND PREVENTIONCDC OFFICE OF ACQUISITION SERVICESATLANTA, GA, 30333, USA

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

Original Source

https://sam.gov/opp/05082b6f019b4c09a94d31c66d42b7ca/view
Timeline
  1. 1
    Posted Jan 21, 2025, 12:00 AM UTC
  2. 2
    Updated Jan 21, 2025, 12:00 AM UTC
  3. 3
    Due Jan 31, 2025, 5:00 PM UTC
Description

The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking qualified sources for the validation and manufacturing of lateral flow assays (LFA) aimed at diagnosing HIV antiretroviral usage in point-of-care settings. The CDC requires an established medical device company capable of producing 25,000 lateral flow devices, which will be utilized in pre-clinical and clinical studies, with the contractor responsible for adapting the provided technical design to their production pipeline and optimizing test performance. This initiative is part of the broader effort to enhance HIV prevention and treatment strategies, emphasizing the need for rapid and cost-effective assays to monitor drug levels. Interested parties must submit their responses, including organizational details and relevant project experience, to Mark Wirtz at mag8@cdc.gov by January 31, 2025, at 12:00 p.m. EST, as this notice is for market research purposes only and does not constitute a solicitation for proposals.

Point(s) of Contact
Mark Wirtz
mag8@cdc.gov
Files
No associated files provided.
Lifecycle
Title
Type
Lateral Flow Assay (LFA) validation and manufacturing
Currently viewing
Sources Sought
Similar Opportunities
CDC DFWED NARST Sensititre Supplies
Buyer not available
The Centers for Disease Control and Prevention (CDC) is seeking to award a sole source contract for antimicrobial resistance testing supplies, specifically Sensititre™ broth microdilution testing products, from ThermoFisher Scientific. This procurement is essential for the National Antimicrobial Resistance Monitoring System (NARMS), which has utilized these proprietary materials since 1996 to ensure a standardized approach to monitoring enteric bacteria resistance. The unique nature of these supplies necessitates this sole source approach, as alternatives would require significant investments in new equipment and validation processes, potentially disrupting critical surveillance efforts. Interested parties may respond within 15 days to express their interest, with proposals directed to contract specialist Ashley Williams at dal3@cdc.gov.
6550--Lab Testing Services - (HIV/HCV/HPV/On)
Buyer not available
The Department of Veterans Affairs is seeking to negotiate a sole-source contract with Roche Diagnostics Corporation for lab testing services related to HIV, HCV, and HPV at the Corporal Michael J. Crescenz VA Medical Center. The contractor will be responsible for providing FDA-approved laboratory systems, instruments, maintenance, and consumables necessary for clinical testing, including a fully automated PCR testing platform with advanced features for real-time detection and minimal maintenance. This procurement is crucial for ensuring the delivery of quality healthcare services to veterans through efficient laboratory solutions. Interested parties must express their interest or submit capabilities by February 13, 2025, and can contact Contract Specialist Yazmin Alvarez at yazmin.alvarez@va.gov or 302-944-2511 x5202 for further information.
Custom Labels Requirement
Buyer not available
The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking to procure custom labeling materials through a sole-source contract with Multisystems Inc. This procurement involves specialized RM 66171 Clear PolyPro labels and Thermal Transfer Ribbon Wax/Resin, which are essential for labeling specimen tubes that must endure extremely low temperatures. The labels are critical for the CDC's dengue research specimen handling and must meet specific requirements, including compatibility with the ZT 230 Printer and compliance with CLIA regulations. Interested parties are encouraged to express their capability to fulfill these requirements by April 4, 2025, and should contact Ashley Williams at dal3@cdc.gov or Sheena Delaine at kpz5@cdc.gov for further information.
NULISAseq CNS Disease Panel 120 Kit or Equivalent
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking information from qualified sources regarding the availability of the Alamar NULISAseq CNS Disease Panel 120 Kit or equivalent products. The objective is to procure three kits to aid in the investigation of biomarkers for neurodegenerative diseases, which are critical for early diagnosis and potential preventive measures. This procurement is essential for the NIH's Laboratory of Clinical Investigation, which focuses on isolating and measuring biomarkers from patient plasma to improve disease detection and management. Interested companies must submit their capability statements by April 11, 2025, to Eric McKay at eric.mckay@nih.gov, ensuring they include relevant details such as their business type and manufacturing information.
Plasma assays of Alzheimer’s disease biomarkers (abeta42, abeta40, ptau217 ) using the Lumipulse assays on the Fujirebio G1200 in the Baltimore Longitudinal Study of Aging (BLSA)
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking a contractor to perform plasma assays of Alzheimer’s disease biomarkers (abeta42, abeta40, ptau217) using Lumipulse assays on the Fujirebio G1200 for the Baltimore Longitudinal Study of Aging (BLSA). The contractor will analyze approximately 4,000 serum/plasma samples, employing senior research specialists to ensure continuity and consistency with prior assays, ultimately contributing to the understanding of cognitive decline and Alzheimer’s disease. This procurement is critical for advancing research on early identification and treatment of Alzheimer’s and related dementias, with a contract period anticipated from May 1, 2025, to April 30, 2026. Interested parties must submit their proposals by 9:00 a.m. EDT on April 11, 2025, to Emily Palombo at emily.palombo@nih.gov.
Notice of Intent to Sole Source - University of Michigan - Vaccine Cost-Effectiveness Models
Buyer not available
The Centers for Disease Control and Prevention (CDC) intends to award a sole source firm fixed price contract to the University of Michigan for access to proprietary models that assess the cost-effectiveness of vaccines. This procurement aims to secure detailed reports based on these models, which are deemed essential for the CDC's vaccine evaluation efforts, as no other models are known to provide the required level of detail. The contract will cover a base year with four additional option years, and interested parties may express their interest or capability to respond within fifteen days of this notice. Responses should be directed to contract specialists William O’Bryan at rvq0@cdc.gov and Ruben Reyes-Colon at qmz3@cdc.gov by 3:00 PM EDT on April 11, 2025.
Acoma Canoncito Laguna Service Unit Cepheid Test Kits
Buyer not available
The Department of Health and Human Services, specifically the Indian Health Service, is seeking qualified vendors to provide Cepheid Test Kits for the Acoma Canoncito Laguna Service Unit Laboratory Department in New Mexico. The procurement includes 300 annual kits of the Xpert Xpress CoV-2/Flu/RSV plus and 120 kits of the Xpert CT/NG for Chlamydia and Gonorrhea testing, with orders placed on an as-needed basis under a firm fixed-price contract lasting one year, with the option for four additional years. These test kits are crucial for the laboratory's diagnostic capabilities, ensuring timely and accurate testing for various health conditions. Interested parties must submit their capabilities and relevant information to Eric Wright at eric.wright@ihs.gov by April 4, 2025, at 12:00 PM (Mountain Daylight Savings Time), and must be registered in the System for Award Management (SAM).
Solicitation W81K00-25-Q-A019 for a Cost-Per-Test (CPT) Agreement to conduct testing for four (4) pathogen panels: Respiratory Virus, Gastrointestinal, Meningitis, and Blood Culture Identification at BAMC.
Buyer not available
The Department of Defense, specifically the Department of the Army, is soliciting proposals for a Cost-Per-Test (CPT) Agreement to conduct testing for four pathogen panels: Respiratory Virus, Gastrointestinal, Meningitis, and Blood Culture Identification at Brooke Army Medical Center (BAMC) in Fort Cavazos, Texas. Offerors are required to provide equipment, reagents, consumables, maintenance services, and telephonic support, ensuring compliance with cybersecurity and Risk Management Framework (RMF) requirements as outlined by the Defense Health Agency (DHA). This procurement is crucial for enhancing diagnostic capabilities and public health initiatives within military healthcare settings. Proposals are due by April 17, 2025, at 1:00 PM Central Standard Time, and interested parties should direct inquiries to Medina L. Woodson or Salameya Paulouskaya via the provided email addresses.
CSS: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease
Buyer not available
The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals for the development of bioanalytical assay methods to evaluate the safety and efficacy of an AAV-based gene therapy candidate for treating Methyl Malonic Acidemia (MMA). The primary objective is to establish qualified assays for measuring T-cell responses and viral shedding in clinical samples, which are critical for assessing the therapy's performance in clinical trials. This procurement is vital for advancing medical research in gene therapy, particularly for rare diseases, and is expected to enhance the understanding of therapeutic impacts on patient health. Interested parties must submit their proposals by April 7, 2025, and can direct inquiries to Kaitlyn Landi at kaitlyn.landi@nih.gov or Khurram Shaikh at kj.shaikh@nih.gov.
Shared Space and Support Services, San Diego
Buyer not available
The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), intends to award a sole source firm fixed price contract to the County of San Diego for shared use of a facility and support services for the US/Mexico Unit and San Diego Quarantine Station. The contract will cover essential services such as installation and maintenance of communication systems, computer support, and building services, which are crucial for facilitating in-person collaboration between CDC staff and the County's Public Health Department. This collaboration is vital to the CDC's mission, with the contract period set from September 1, 2025, to August 31, 2026, and options for two additional one-year extensions. Interested parties should submit their responses to the contract specialist, Taylor Wellman, at xur0@cdc.gov by 5:00 PM (ET) on April 4, 2025.