SSJ_Roche_6.16.17_(3).Desposito_Chris_-_Redacted.pdf

Control No: JA17138

"For Official Use Only”

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity

(USAMRAA).

2. Requiring Activity: Walter Reed Army Institute of Research (WRAIR).

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price:

**Time & Materials:

* Cost:

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds:

Fiscal Year of Funds:

Estimated Total Dollar Value including Options: $ 1,950,000.00 BPA Ceiling

4. Contractor Name:

Name of Proposed Contractor(s): Roche Diagnostics Corporation Street Address: 9115 Hague Rd City, State, Zip: Indianapolis, IN, 46256-1025 Phone: (317)521-7996/ (317)521-5320

DUNS: 001824663

Cage Code: 51169

5. Description of Supplies/Services:

This requirement is for the lease of one Roche TaqMan 48 Analyzer (SN 2415) and preventive maintenance of the COBAS AmpliPrep Instrument (SN 392095), COBAS TaqMan 48 Analyzer (SN 1905), and TaqMan 48 Analyzer (SN 2415 rental) and corresponding supplies that include test kits/reagents/consumables. The resultant BPA will have an ordering period of 5 years with a $1,950,000.00 ceiling.

The required kits, reagents, and consumables are necessary to provide HIV-1 Viral RNA testing services to Military Treatment Facilities (MTFs) to monitor the HIV Viral Load (VL) in plasma specimens received from HIV-1 infected Service members and beneficiaries, HIV VL values are used by clinicians to establish HIV-1 drug treatment regimens for the Department of Army and DoD as part of standard-of-care for HIV-1 infected Soldiers and their beneficiaries. In addition, the HIV Diagnostics and Reference Laboratory (HDRL) performs HCV Viral Load testing upon request and to assist in Diagnosis as HIV infected individuals can also be co-infected with HCV. The tests that will be performed are FDA cleared for performance on the Roche COBAS AmpliPrep/COBAS TaqMan 48 platform system. The HIV-1 VL test is the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0. The HCV VL test is the Roche COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0.

Essential requirements are:

a. The Roche COBAS AmpliPrep instrument (robotic nucleic acid extraction) and the Roche COBAS TaqMan 48 analyzers and are either owned by the laboratory or included in the reagent/rental/service agreement as noted above. Test Kits, reagents and consumables must be qualified for performance on this system and have FDA clearance.

b. The HIV-1 and HCV Viral Load tests must utilize a dual probe/ primer target design that provides for redundancy against current and potential future polymorphisms that can interfere with amplification of the target region in the assay.

c. The COBAS AmpliPrep/COBAS TaqMan 48 Analyzer System is a closed platform where reagents, samples and reaction tubes are capped and are not open to the environment. A closed system is preferred to one that is open.

d. The lower limit of detection and quantification must be 20 HIV-1 RNA copies/ml with a maximum at 10 million copies/ml. The lower limit of detection/ quantification for the HCV Viral Load test must be 15 IU/mL with a maximum of 100 million IU/ml.

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited:

Only Roche Diagnostics Corporation can meet the Government requirements. There are no equivalent product on the market that is compatible with the Roche COBAS AmpliPrep/COBAS TaqMan platform currently used in WRAIR HIV Diagnostics and Reference Laboratory.

HDRL requires the Roche Molecular Diagnosis kits, reagents, consumables and instruments to conduct HIV VL testing to provide critical clinical test results to clinicians for use in drug treatment decisions. Failure to do so will impact the ability of clinicians to treat HIV-1 infected service members and beneficiaries according to recommendations of the Health and Human Services (HHS), Center for Disease Control (CDC) and the Army Public Health Command. HIV is a lentivirus that causes the acquired immunodeficiency syndrome (AIDS). The Army Surgeon General has responsibility for the health and welfare of each HIV-1 infected Service member and beneficiary. Failure to decrease HIV-1 VL to undetectable in HIV-1 infected soldiers and beneficiaries can lead to a diagnosis of AIDS, transmission of virus and impact the preparedness of the US Armed Forces.

The Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 and HCV assays are validated in HDRL for use in clinical testing operations according to the College of American Pathology (CAP) and Clinical Laboratory Information Act (CLIA) regulations. No other assay is available for that purpose.

The HRDL currently uses the Roche COBAS AmpliPrep/COBAS TaqMan platform to perform HIV-1 Viral Load and HCV Viral Load testing to monitor viral RNA levels in HIV- 1 infected Soldiers and beneficiaries and in HCV infected individuals (special request).

Specimens are received from the Walter Reed National Military Medical Center which includes both Department of Army and Navy samples and Army MTFs Monday thru Friday for HIV-1 Viral Load testing. Turnaround time for the HIV-1 VL test result is 5 business days. The Medical Command (MEDCOM) requires the use of FDA cleared reagents and instruments for HIV-1 and HCV VL measurement; Roche Molecular Diagnostics reagents and instruments fulfill that requirement.

The Roche COBAS Ampliprep/ COBAS TaqMan test kits, reagents and consumables are the only reagents and supplies that can be used on the COBAS AmpliPrep/COBAS TaqMan 48 Analyzer System. Roche Diagnostics Corporation, Inc. is the only company that can sell and provide the kits, reagents, consumable and instruments. The reagent, rental and service agreement is critical for HDRL to perform HIV-1 VL testing to provide information critical to physicians for use in monitoring antiretroviral therapy treatment of HIV-1/HCV infected Service members and beneficiaries.

8. Efforts to obtain Competition:

Market research has indicated that Roche Diagnostics Corporation is the only manufacturer and distributer of the COBAS kits, reagents, consumables, and instruments.

a. Effective competition: N/A. No competition is anticipated for this acquisition as

Roche is the only manufacturer and distributer of the required assays.

b. Subcontracting competition: N/A. No subcontracting opportunities exist for this requirement.

9. Actions to remove or overcome barriers Competition: Until such a time that Roche Diagnostics Corporation allows other distributers to sell their equipment, the requirement to obtain Roche’s products by means of other than full and open competition will continue to exist.

10. Market Survey The majority of clinical testing laboratories in the United States use one of two FDA cleared HIV-1 Viral Load tests. The Roche COBASAmpliPrep/COBAS TaqMan HIV-1 Test v2.0 is performed by the largest number of laboratories in the United States. The Roche HIV-1 VL load tests have been performed since 1997 in HDRL to provide HIV-1 VL results to military clinicians. HIV-1 VL test results have been shown to be consistent among kit versions and changes in instrumentation.

The Abbott RealTime HIV-1 Test performed on the m2000sp/rt system is the second largest test used in the United States. This system is not preferred for the following reasons: The Abbott m2000 sp/rt RealTime PCR tests are not compatible with current instrumentation, is an open platform, single target region and targets the region to which HIV-1 drugs are targeted. Differences in HIV-1 VL results are observed between the two assays and as such may affect drug treatment decisions by physicians.

The Roche COBASAmpliPrep/ COBAS TaqMan system is the only fully closed nucleic acid amplification platform approved by the FDA. As contamination with previously amplified PCR product or with specimens having over 10 million RNA copies per ml is an issue when using open platforms, the Roche COBAS AmpliPrep/ COBAS TaqMan system is superior to other systems, mitigating risks that can result in a contaminated environment that can compromise PCR test results.

Additionally, COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 test is FDA cleared for use in the monitoring of HIV-1 viral RNA in plasma from HIV-1 infected individuals.

The Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 is approved for use in the monitoring of HCV viral RNA in HCV infected individuals.

Both assays are quantitative RT-PCRs assays based upon TaqMan chemistry with dual target amplification, which mitigates performance issues associated with nucleotide base changes in the viral RNAs due to evolution. In addition, the COBASTaqMan HIV-1 test v2.0 targets regions that are not targeted by antiretroviral drugs.

There is no laboratory space within the clinical testing building to accommodate another FDA cleared PCR robotic platform. Any change in instrumentation and test kits/reagents will result in a complete shutdown of operations for two or more months.

The cost to verify/validate each assay and to train technologists on another FDA cleared assay platform is estimated at greater than $40,000 per assay.

11. Interested Sources:

To date, as there are no other approved supplier of the Roche kits, reagents, consumables and preventative maintenance service for their equipment.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: Cooperative agreement W81XWH-

11-2-0174 and contract W81XWH-15-A-0016.

Previously competed? No

Previous authority for less than Full & Open Competition: 10 U.S.C. 2304(c)(1) as implemented in the Federal Acquisition Regulation 6.302-1(a), Only one responsible source and no other supplies or services will satisfy agency requirement.

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Submitted by Signature:

DAVIS.MALINDA.LASALLE.1263191311

Digitally signed by DAVIS.MALINDA.LASALLE.1263191311 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=DAVIS.MALINDA.LASALLE.1263191311 Date: 2017.06.12 11:22:33 -04'00'

Printed name: CPT Malinda Davis Agency/Position/Title: WRAIR-HDRL/Assistant Lab Manager/COR E-Mail Address: il Date: 12 June 2017 mailto:Malinda.l.davis2.mil@mail.mil

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Digitally signed by

PIAR.COURTNEY.A.1362116348

Contracting Officer Signature:

Printed name: Courtney Piar 1362116348

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=PIAR.COURTNEY.A.1362116348 Date: 2017.06.13 13:03:05 -04'00'

Agency/Position/Title: USAMRAA/Contracting Officer E-Mail Address: courtney.a.piar.civ@mail.mil Date: 13 June 2017

PIAR.COURTNEY.A.

mailto:courtney.a.piar.civ@mail.mil

15. I hereby determine this SSJ to be Legally Sufficient.

Typed Name: Date:

Title: Signature:

ESPOSITO.DIANA.JO

AN.1517024593

Digitally signed by

ESPOSITO.DIANA.JOAN.1517024593

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=ESPOSITO.DIANA.JOAN.1517024593 Date: 2017.06.14 14:46:28 -04'00' cn=SHERMAN.CHRISTOPHER.E.1230688741

Approval

Based on the foregoing justification, I hereby approve the procurement of ease of one Roche TaqMan 48 Analyzer (SN 2415) and preventive maintenance of the COBAS AmpliPrep Instrument (SN 392095), COBAS TaqMan 48 Analyzer (SN 1905), and TaqMan 48 Analyzer (SN 2415 rental) and corresponding supplies that include test kits/reagents/consumables on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 or 41 U.S.C. 1903, as implemented by FAR 13.501(a)(1)(ii), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Digitally signed by

SHERMAN.CHRISTOPHER.E.1230688741

DN: c=US, o=U.S. Government, ou=DoD, PHER.E.1230688741 ou=PKI, ou=USA, Date: 06/16/2017 Signature: Date: 2017.06.16 12:10:25 -04'00'

Christopher E. Sherman Special Advocate for Competition