postable JA 36C10G22D0036 P4 Redacted.pdf
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- Solicitation number
- 36C10G22D0036
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This document is a Justification and Approval (J&A) for Other Than Full and Open Competition for a six-month contract extension with Natera Inc. for Minimal Residual Disease (MRD) Testing Services for the Department of Veterans Affairs (VA) National Precision Oncology Program. The extension covers MRD next generation sequencing based tests (somatic and germline), immunohistochemistry, microarray, FISH, and other cancer testing methodologies across 130 VA Medical Centers, with the period running from March 15, 2025 through September 14, 2025.
The justification indicates the contract was originally awarded as a competitive Indefinite Delivery Indefinite Quantity (IDIQ) contract, and this extension is needed to allow the VA time to finalize performance requirements and complete market research for a recompete effort. The National Precision Oncology Program determined the testing service is advantageous for early cancer cell detection and wants to continue the current services while preparing a new contract. The extension will utilize existing products and pricing previously determined to be fair and reasonable, with no new products or tests to be added during this period.
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| 36C10G22D0036 P00004_1.docx | DOCX document |
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JUSTIFICATION AND APPROVAL
FOR OTHER THAN FULL AND OPEN COMPETITION
1. Contracting Activity: Department of Veterans Affairs (VA)
Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center 10300 Spotsylvania Ave, Suite 400 Fredericksburg, VA 22408
2. Description of Action: Issuance of a modification to extend the Period of Performance (POP) to contract 36C10G22D0036 for Minimal Residual Disease (MRD) Testing Services with Natera Inc., 13011 McCallan Pass, Bldg. A STE 100, Austin TX 78753. This modification will put in place a 6-month extension period to continue providing MRD next generation sequencing based tests (somatic and germline), immunohistochemistry, microarray, FISH and other standard and emerging test types and methodologies performed with patients with cancer across the 130 VA Medical Centers for Veterans.
This contract was awarded under a competitive effort Indefinite Delivery Indefinite Quantity (IDIQ) wherein individual VA Medical Center facilities have the authority to place delivery orders against the IDIQ. There is a bonafide need for this testing. When the contract was award, there was no testing conducted for the first two quarters of the period of performance and an extension to the period of performance was awarded to allow for further observation into the validity of another contract for these services. The acquisition of a follow-on contract is currently on going.
Currently, the National Precision Oncology Program (NPOP) office has gathered enough information to decide that the continuation of this type of testing service is in the best interest of Veteran’s care. The process of finalizing the performance requirements for the recompete effort for this type of testing requires additional time to finalize these documents as well as complete market research. NPOP is requesting a six (6) month extension to fully complete this effort.
3. A description of the supplies or services including the estimated value:
The Department of Veterans Affairs (VA) National Oncology Program requires the extension of the Minimal Residual testing services. This testing is being used for patients after surgical resection across tumor types to detect tumor
36C10G22D0036 P00004 Justification for Other Than Full and Open Competition recurrence or for tumor monitoring for therapy response and effectiveness in both the adjuvant and metastatic setting.
The specific types of testing are as follows.
ITEM ISSUE AMOUNT TOTAL
2001 MRD TESTING
2001AA MRD Baseline Tumor Test
The estimated dollar value increase is . The estimated dollar value is based on an analysis of the spend for 4th Quarter FY24 and the 1st Quarter FY25 obtained from the Quarterly Sales Report (QSR). The average monthly sales is approximately . This estimated value is most representative of the projected surgical implant market environment during the extension period.
The current period of performance will expire on March 14, 2025. The requested extension will be from March 15, 2025, through September 14, 2025.
4. Statutory Authority: The statutory authority permitting other than full and open competition is Title 41 United States Code (U.S.C.) § 3304(a)(5), Federal Acquisition Regulation (FAR) subpart 6.302-1 entitled, “Only one responsible source and no other supplies or services will satisfy agency requirements.
5. Rationale Supporting Use of Authority Cited Above:
The MRDT testing service was utilized as a pilot testing service to see the effectiveness to detect tumor recurrence or for tumor monitoring for therapy response and effectiveness in both the adjuvant and metastatic setting. NPOP has determined that the effectiveness of this type of testing service is advantageous for early detection of cancer cells and would like to continue with the current services while the recompete effort is underway.
6. Efforts Made to Solicit Offers from as many potential sources as practical:
Utilizing the authority in Title 41 United States Code (U.S.C.) § 3304(a)(5), Federal Acquisition Regulation (FAR) subpart 6.302-1, it is appropriate to award this acquisition to Natera Inc. without regard to any other provisions of law, to include full and open competition.
7. Determination of Fair and Reasonable Cost: Price reasonableness will be conducted in accordance with 41 U.S.C. 3501 and FAR 15.403-1(c)(3)(ii)(B), “Commercial Items”, which states that in order to make this determination, the
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