WRAIRFusionSSJ_SP_Redacted.pdf

Control No:

Contractor: Gen-Probe

Program/Equipment: Panther Fusion

Version – March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS – SOLE

SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment Diagnostics and Countermeasures Branch (DCB) to acquire Panther Fusion open access platform for the purpose of Performance Assessment, Enhancement and Transition to High Throughput 2019-Novel Coronavirus (COVID-19) Real-Time RT-PCR Assay on the Gen Probe Panther.

Authority Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1903 for Special Emergency Procurement as implemented by FAR Subpart 13.5.

Amount:

Prepared by: DSN:

Date: 02/25/2020

Contracting Officer: DSN:

Date: 02/25/2020

Technical Phone:

& Requirements : Date: 02/27/2020

Reviews I have reviewed this justification and find it adequate to support sole source.

WRAIR

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity The Contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Description of Action The requiring activity for this action is Walter Reed Army Institute of Research (WRAIR). WRAIR requests a firm-fixed-price contract with Gen Probe. The Government projects award for February/March 2020 using Fiscal Year 2020 .

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3. Description of Supplies/Services Diagnostics and Countermeasures Branch (DCB) to acquire the Panther Fusion open access platform for the clinical Panther system currently deployed within DCB and implement Gen Probe pan-coronavirus (OC43, HKU1, NC63, 229E) and Gen Probe SARS-CoV-2 EUA assays.

Gen-Probe is the only vendor that can provide proprietary services and consumables for the Panther System, due to the fact that its parent company, Hologic, has not licensed the right to sell or maintain its products to any other vendors. USAMRAA currently has a Blanket Purchase Agreement (BPA) with Gen-Probe Incorporated. BPA # with a period of performance 10 APR 2019 to 09 APR 2024 for reagents and supplies.

Delivery of this equipment is expected within the next two weeks.

4. Authority Cited Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1903 as implemented by FAR Subpart 13.5:

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other:

5. Reason for Authority Cited SARS-CoV-2 – the causative agent of coronavirus disease 2019 (COVID-19) - was detected in Wuhan, China in December 2019 and has infected more than 80,000 individuals globally and caused over 3000 deaths including two U.S citizens. The COVID-19 outbreak has been declared a Global Health Emergency by the World Health Organization. Diagnostic test capability for detection of SARS-CoV-2 is seriously limited; the deployment of the U.S. CDC Emergency Use Authorization assay has been plagued by problems with reagents, thus delaying implementation of testing in U.S. civilian and DOD laboratories. The current SARS-CoV-2 diagnostic assays available within the U.S are executed on low throughput systems within both civilian and U.S. Military laboratory systems (30-60 patient tests per 8 hour period); thus limiting the ability to scale up to high-volume testing required in the dynamically changing epidemic situation. This is of great concern to U.S. Army senior leaders; specifically, with regard to the lack of high throughput available to detect this infection in U.S. Military Operational and Deployed Forces. The identification of 77 SARS-CoV-2 infected U.S. citizens and two U.S. Service Members (1 in South Korea, 1in Italy) has critically underscored the mission essential requirement for robust, expanded test capability within the U.S. Military.

The Panther Fusion open access platform is a high-throughput platform technology that can be implemented for rapid coronavirus detection, Gen Probe pan-coronavirus (OC43, HKU1, NC63, 229E) and Gen Probe SARS-CoV-2 EUA assays. The capability includes:

a. Multi-genic primer sets for pan-coronavirus and SARS-CoV-2-specific qualitative RT-PCR test on primary respiratory specimens implemented in a CAP accredited environment.

b. Commercially available technology specifically designed for high-throughput (225-500 specimens per 8 hour) execution of laboratory developed tests compared to current lower throughput (39- 54 specimens per 8-10 hour) technology.

c. Ability to interface with MHS clinical diagnostic systems.

Hologic, Inc is the sole manufacturer and distributor of the Panther System, and that it owns the Intellectual Property for this system. It further certifies that the use of any third-party products on its proprietary system would render the warranty void for the system. Hologic has not licensed or granted to any third party the right to provide maintenance and support services for the system. Only Hologic trained service personnel are authorized to service the DTS and Panther System.

6. Efforts to Obtain Competition Effective competition is not expected.

7. Actions to Increase Competition Gen-Probe is a subsidiary of Hologic, Inc. To date, Hologic has not granted any other third parties with a license to sell or service any of its products. It is anticipated that further efforts to generate competition will not be effective prior to award

8. Market Research Market research revealed that Gen-Probe is the only vendor that can provide proprietary services and consumables for the Panther System, due to the fact that its parent company, Hologic, has not licensed the right to sell or maintain its products to any other contractors.

No other vendors in the industry can provide the Panther System as they have no authorized third parties.

9. Interested Sources To date no other source has expressed an interest in the acquisition.

10. Other Facts

a. Procurement History

(1) Contract numbers and dates of the last several contracts for these same requirements.

• Period of performance 10 APR 2019 to 09 APR 2024

(2) The competitive status of these actions.

• A Request for Information (RFI) was posted to FedBizOpps (FBO) for and no other vendor was considered technically acceptable.

(3) Authority previously cited if less than full and open competition was used.

• N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

• N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

• N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

• N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

• N/A

11. Technical and Requirements Certification I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

WRAIR

12. Fair and Reasonable Cost Determination I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following:

Price analysis Cost analysis

IGE

Audit:

Other:

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

USAMRAA

13. Contracting Officer Certification I certify that this justification is accurate and complete to the best of my knowledge and belief.

USAMRAA