SSJ Cepheid GeneXpert Kits_Equipment_Redacted.pdf

Control Number: FY26-0523

Source Selection Information – See FAR 2.101 and 3.104

CUI//PROCURE

CUI//PROCURE

4. This acquisition is conducted under the authority of 10 U.S.C. 3204(a)(1) as implemented by FAR 6.103-1(b): One responsible source. Agencies may contract without providing for full and open competition when the supplies or services required by the agency are available from only one responsible source and no other type of supplies or services will satisfy agency requirements.

5. Proposed Contractor’s unique qualifications-justifying use of the regulatory authority cited:

Cepheid GeneXpert is the current instrumentation in place at the 96 MDG. The Cepheid GeneXpert Family v6.x AI serves as a rapid Molecular Diagnostics system which automates and integrates sample preparation, nucleic acid amplification, and detection of the target sequence in simple or complex samples using RT-PCR. The system is suited for in vitro diagnostic applications that require hands-off processing of patient samples (specimens) and provides both summarized and detailed test results data in tabular and graphic formats. The GeneXpert System is designed exclusively for the use of the Cepheid Xpert assay applications. Cepheid uses self-contained test kits preventing the need for additional PCR equipment for extraction, amplification, and detection of SARS-CoV-2, Methicillin-resistant Staphylococcus aureus, Streptococcus (Group A), Influenza type A, Influenza type B, Respiratory Syncytial Virus, Bacterial Vaginosis, Candida Group (including glabrata and krusei), and Trichomonas vaginalis. The GeneXpert does not require independent water or plumbing to system which allows for easier disaster recovery relief and ease of moving analyzers if/when necessary.

Cepheid’s GeneXpert systems have the capability to maintain 100% of Eglin’s master test list within the laboratory ensuring consistent and reliable results, directly impacting patient care by providing timely and accurate test results to providers. Real-time same day PCR molecular testing is utilized for rapid treatment of 12,000 tests annually for the surrounding 123,000 Eglin beneficiary population to aid within appropriate clinical treatment, return to duty readiness status, and public health reporting to the Florida Department of Health. Without molecular capabilities, notification and treatment are delayed upwards of 72 hours due to the requirement to resort to shipping to an approved military reference laboratory for testing, which ultimately adds to turnaround times and state reporting in addition to ineffective patient care. The GeneXpert systems are validated with the Military Health System (MHS) GENESIS Electronic Medical Record (EMR) which ensures no disruption in current operations and reduces the risk associated with extensive revalidation and implementation processes required by other systems. Acquiring any other reagents other than the Cepheid GeneXpert System kits would necessitate replacing the current, functional molecular RT-PCR instrumentation which would incur unnecessary costs. There are several real-time PCR analyzers on the market that produce similar results via different methodology. The reagents used in other analyzers vary quite differently to include the need for precisions pipetting and/or require batch testing. No other vendor offers 100% of the required testing menu currently offered by the GeneXpert System PCR amplification within one hour of testing on a molecular, walk away instrument utilizing closed cartridge technology. The use of different instrumentation would require rigorous validations as well as retraining in the proper use of the new instrument(s), reagents, specimen collection, and waste disposal for both laboratory personnel as well as all clinical staff.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as possible: A notice of intent to award a sole source action for a closed-system Real-Time Polymerase Chain Reaction (RT-PCR) molecular analyzer and reagents was posted to the Government Point of Entry on 30 January 2026 in accordance with FAR Part 5. The notice provided a 16-day response period, closing on 14 February 2026 for any responsible sources to submit a response inclusive of business identification (name, type, socio-economic status) and a capability statement narrative.

Control Number: FY26-0523

Source Selection Information – See FAR 2.101 and 3.104

CUI//PROCURE

CUI//PROCURE

7. Anticipated cost to the Government will be fair and reasonable: Contracting Officers are responsible for evaluating and documenting the reasonableness of the awarded price in accordance with FAR 15.4. Agencies must purchase supplies and services from responsible sources at fair and reasonable prices. The Contracting Officer will analyze various price elements that are presented in the quote/proposal, as well as review actual costs from previous and comparable procurements from other Governmental Agencies as well as open market prices to form a fair and reasonable price determination for the supplies/services covered by this justification.

8. Description of the market research conducted among schedule holders and the results, or statement of the reason market research was not conducted: Searches were performed on GSA Advantage, SAM.gov, and the open market for GeneXpert closed-system RT-PCR analyzers/reagents and similar terms between 11 December 2025 and 22 January 2026. A thorough analysis was conducted through market research and mandatory and non-mandatory sources.

The results from market research confirm Cepheid is the original equipment manufacturer and sole provider of the proprietary GeneXpert system and reagents. Additionally, Cepheid provided a sole source letter dated 20 January 2026 corroborating that they are the sole source for the GeneXpert system and reagents in the United States.

9. Other Facts supporting other than full and open competition:

a. Procurement History:

(1) Is this a new requirement? Yes, this is a new DHA requirement.

(2) If 9.a.(1) is No, was the action just prior to this one competed? Not applicable.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not Applicable

b. Additional Information: Not Applicable

10. Listing of any sources that expressed interest in this acquisition: Responses to the market research conducted indicate that other potential sources do not have a molecular analyzer that can meet the Government’s needs at this time and/or directed the Contracting Officer to contact Cepheid Inc. to satisfy the requirement.

11. Efforts to Obtain Competition: The 96th MDG will continue to evaluate product capabilities of other vendors and manufacturers through continuing market research and meeting with vendors for demonstrations of their products.