Hologic Panther JA for IDIQ Final Sign_Redacted.pdf

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Control Number: FY26-0525

Hologic Panther Plus Analyzer Systems Justification and Approval (J&A) Federal Acquisition Regulation (FAR) 6.103-1 Only one responsible source and no other supplies or services will satisfy agency requirements

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division (HCD) - South

2. Nature and/or Description of Action being Approved: HCD-S intends to award a Single Award, Finn-Fixed-Price (FFP), Indefinite-Delive1y/Indefinite-Quantity (IDIQ) contract to Hologic, Inc for all consumables, reagents, assays, and associated lease of two (2) Hologic Panther Plus Analyzer systems in accordance with FAR 6.103-1.

3. Description of Supplies/Services: This supply requirement is for Hologic consumables, reagents, assays, and associated lease of two (2) Ho logic Panther Plus Analyzer systems (Pali No. PRD-06067) in suppo1i of the 59th Medical Wing (MDW) Microbiology and Immunology Laborato1y at the Wilford Hall Ambulato1y Surgical Center (WHASC), Joint Base San Antonio (JBSA) Lackland, TX.

This agreement shall include ongoing maintenance of the analyzers, as well as all associated equipment, reagents, controls, consumables, training, and technical support. The Panther Plus systems are required to perfonn time-critical, in-house nucleic acid testing for Chlamydia trachomatis (CT), Neisseria gononhoeae (GC), Bacterial Vaginosis (BV), Candida species, and Trichomonas vaginalis.

Period ase Period tion Period 1 tion Period 2

Period of Performance e ofFundin

10 Feb 2026- 9 Feb 2027 O&M 10 Feb 2027 - 9 Feb 2028 O&M 10 Feb 2028- 9 Feb 2029 O&M

Total

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4. Statutory Authority Permitting the Sole Source Acquisition: 10 United States Code 3204(a)(1) as implemented by FAR 6.103-1: Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Authority Cited:

Hologic Inc. is the only company that supplies the necessary analyzers, consumables, reagents, and assays that meet the salient requirement specifications as required by the 59th MDW. As such, Hologic, Inc. is the only company capable of fulfilling the Government’s needs. See below as follows:

59th MDW Throughput Requirement: The laboratory requires the capacity to process up to 500 tests in an 8-hour period to meet mission and patient care demands. Due to the unique mission of Basic Military Training (BMT), two (2) Hologic Panther units are required to ensure that there is no downtime in testing protocols. Other systems, as discussed in section 8 market research, lack the required throughput, which would lead to testing backlogs and delays in patient care.

Physical Footprint: The laboratory has a limited maximum space of 57" (W) x 39" (D) x 69" (H) to fit any type of analyzer. The laboratory cannot change these size limitations without moving walls or other permanent fixtures and equipment. Making any of those changes will affect the lab and other clinics to the level of mission failure. Wilford Hall Ambulatory Surgical Center is a new facility specifically designed for organizational flow and is unable to accommodate renovation and construction changes without mission failure. Two Hologic Panther Plus Systems will fit within the existing limited space allowing and operate side-by-side for necessary redundancy. Competing systems such as the Roche Cobas 6800/8800 and Abbott Alinity significantly exceed these dimensional limitations.

Required Test Menu: The analyzer must be capable of performing the full panel of tests currently utilized, including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Bacterial Vaginosis (BV), and Candida species. While the Cepheid GeneXpert system was considered, available information did not show that it offered this complete panel of required assays.

Mission Impact: Failure to secure the Hologic Panther Plus systems poses a direct and significant threat to patient care at the 59th Medical Wing. Without this specific technology, the laboratory's ability to perform time-critical, in-house nucleic acid testing would cease, forcing all samples to be outsourced. This would introduce critical delays preventing physicians from initiating timely treatment, increasing the risk of unchecked disease transmission within the military community and exposing patients to severe, long-term health complications. The absence of this capability would directly compromise the standard of care and endanger the health of service members and their families. From an operational standpoint, this failure would cripple the medical readiness mission of the Military Treatment Facility (MTF). A service member awaiting a diagnosis is not medically ready for deployment or duty, directly impacting unit effectiveness. As such. by ensuring the health of all recruits in Basic Military Training, the 59th Medical Wing will continue to provide the foundational medical readiness essential to the entire U.S. Air Force mission.

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Furthermore, market research confirms that no alternative system can meet the required testing throughput within the laboratory's physical constraints, meaning a switch in platforms would create immediate and unmanageable testing backlogs, overwhelming staff and resources. As no other vendor can meet the Government’s minimum needs, not fulfilling this requirement would result in a critical loss of diagnostic capability, fundamentally degrading the 59th MDW’s ability to support the warfighter and execute its core mission.

Additionally, the absence of Hologic consumables, reagents, assays, and the associated lease of two Hologic Panther Plus Analyzer systems would prevent the rapid diagnosis and treatment of these common conditions, leading to untreated infections. This would also compromise the BMT Pipeline. Without the Hologic capabilities, tests would be sent to external facilities, increasing turnaround times for test results from 24 hours to five to seven business days for most tests and from two hours to 24 hours for other tests. This, in turn, affects service members’ ability to promptly return to training. Failure to screen and treat BMT trainees in a timely manner will lead to an increased risk of outbreaks within the training environment, causing medical holdovers and delaying the graduation of personnel to their first duty stations. This would have a significant negative impact on Member Health. The loss of this core diagnostic capability represents a failure in the ability to provide comprehensive and timely medical care to service members, negatively affecting morale and trust in the military medical system.

Proprietary System and Consumables: The laboratory currently requires the throughput capabilities that only the Hologic Panther analyzers can provide. Only one other system can provide this throughput but cannot do so within the footprint of the laboratory. Reagents, consumables, and controls required to operate these analyzers are proprietary to Hologic, Inc.

The company is the sole manufacturer and distributor of these products in the United States and, as stated in their correspondence, does not utilize third-party vendors or resellers for diagnostic products. Therefore, to acquire the necessary supplies while maintaining the necessary throughput for testing and comply with size constraints, the Government must contract directly with Hologic Inc.

Failure of Alternatives to Meet Salient Characteristics: Market research, in paragraph 8 below identified and evaluated the potential alternatives. These alternatives all failed to meet one or more of the Government's minimum requirements.

6. Efforts to Obtain Competition:

In accordance with Federal Acquisition Regulation (FAR) 5.201, a notice of intent to award a sole source action for the supply of consumables, reagents, assays, and the associated lease of two (2) Hologic Panther Plus Analyzer systems was published on the System for Award Management (SAM.gov) on January 8, 2026. The notice provided a 15-day response period, closing on January 23, 2026, for any responsible sources to submit a capability statement. The Government’s notice of intent to sole-source yielded zero interested parties aside from Hologic Inc.

In parallel, direct inquiry was made with the Original Equipment Manufacturer (OEM), Hologic, Inc. On December 3, 2025, a company representative (Olivier Girard) confirmed that Hologic, Inc is the sole provider of its Panther instrumentation. The representative further stated that Hologic, Inc does not utilize third-party vendors or resellers for its diagnostic products in order to maintain strict adherence to medical testing regulatory compliance. As a result of these findings, the Government has determined that no other source is capable of providing the required proprietary equipment and supplies.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

The Hologic Panther Plus systems are proprietary, and the necessary reagents, consumables, and maintenance services are available only from the OEM, Hologic, Inc. The company has confirmed it does not use third-party distributors for its diagnostic products, making them the only source capable of preventing a disruption to the 59th Medical Wing's mission.

However, in order to increase competition for any subsequent acquisitions, the Government will continue to conduct market surveillance to identify new technologies and vendors in the automated nucleic acid testing marketplace. We will actively monitor competitors such as Roche, Abbott, BD, and Cepheid for advancements in their platforms that may meet the Government’s technical and physical requirements in the future.

Additionally, prior to the next acquisition cycle, the requiring activity will re-evaluate the salient characteristics, including throughput, physical footprint, and the required test menu. This review will ensure the requirements are not overly restrictive and accurately reflect the Government's minimum needs, thereby maximizing the potential for competition. At this time, there is no expectation of being able to overcome competition barriers due to the unique attributes and test production of the Hologic Panther unless new state of the art technology is produced.

8. Market Research:

HCD-S Bravo Branch conducted market research the week of 15 December 2025 and did a follow-up search more recently to confirm the information below has not changed.

The contract specialist used the salient characteristics required by the customer to research comparable analyzers. The analyzers cannot exceed the following dimensions, 57 in (W) x 39 in

(D) x 69 in (H) based on the available workspace and inability for the clinics to be physically changed without affecting MTF ability to meet the mission. The analyzers will be used to provide support for testing for Gardnerella vaginalis, Candida species, Candida glabrata, and Trichomonas vaginalis, which can cause vaginal infections. Each analyzer must be able to process up to 500 tests of any combination of test in an 8-hour period to ensure no downtime in testing.

The contract specialist discovered in the commercial marketplace that only the Hologic Panther System met the above requirements. Close competitor analyzers that only partially met the requirements above are listed below followed by reason for not meeting requirement:

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a) Roche Cobas 6800/8800 Systems

These systems exceed the dimensional requirements of 57" (W) x 39" (D) x 69" (H). The Cobas 6800 is 115" wide and the Cobas 8800 is 169" wide.

Source: https://www.blockscientific.com/roche-cobas-6800

b) Roche Cobas 5800 System

While this system has a smaller footprint, its throughput is a maximum of 144 results in an 8-hour shift, which is below the required 500 tests.

Source:

https://safe.menlosecurity.com/doc/docview/viewer/docN824CE0AF705A53f946604111c04a56 50f77a01bbfbc50df21bd67701460ce7ba512efa5193db

c) Abbott Alinity

This analyzer is 98 inches wide, which exceeds the size limitations. It also has a lower throughput of approximately 300 results in 8 hours.

Source: https://www.molecular.abbott/int/en/products/infectious-disease/alinity-m-product-overview

d) BD MAX™ System

The BD MAX™ System has a much lower throughput, estimated at around 96 samples in an 8-hour period, which is well below the 500-test requirement.

Source:

https://safe.menlosecurity.com/doc/docview/viewer/docN824CE0AF705Aa22ef5c233ab88eed5f 3400234124877326df61f5ec23bb174aa182a36da2ab7

e) Cepheid GeneXpert Systems

While the high-end GeneXpert Infinity-80 system can meet the throughput and size requirements, it is unclear from the available information if it offers the complete panel of required assays for Gardnerella vaginalis and Candida species. The lower-throughput GeneXpert models do not meet the testing volume requirement.

Source: https://www.imperialbiotek.com/Cepheid.php

No other commercially available system meets the minimum physical and technical requirements for throughput and size. Purchasing proprietary reagents and supplies is therefore necessary for the function of the system, making Hologic, Inc. the only source capable of satisfying the

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agency's needs. An award to any other source would result in decreased throughput of tests, significantly disrupting Basic Military Training (BMT) candidate in-processing and progress towards graduation – a key to the Air Force’s future readiness.

Therefore, a sole-source acquisition is not only justified but necessary to ensure the continuity of medical services at the 59th Medical Wing.

9. Other Facts:

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. Interested Sources: Hologic Inc. was the only company to respond to the Government’s notice of intent to sole-source.

11. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Sherry Trevino GS-12, MT (ASCP), SM, MPH Supervisor, Microbiology-Immunology

12. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Jessica Mae Pilapil, SSgt, USAF

NCOIC, MEDLOG

Lackland Medical Logistics & Readiness Squadron Wilford Hall Ambulatory Surgical Center