SAM #36C26127Q0083

VA sole-source heart-transplant rejection surveillance testing from CareDx

VA NCO 21 plans to sole-source heart-transplant rejection surveillance testing to CareDx for VA Palo Alto patients. - Procurement approach: The Department of Veterans Affairs intends to award CareDx a sole-source, firm-fixed-price IDIQ contract. This is an intent-to-sole-source notice, not a request for quotations. - Services: Testing uses CareDx’s proprietary AlloMap gene expression profiling assay and AlloSure donor-derived cell-free DNA (dd-cfDNA) assay. - Estimated annual volume: Approximately 100 AlloMap tests and 65 AlloSure tests. CareDx must provide testing supplies and specimen support; mobile phlebotomy is required as needed, with no quantity specified. - Laboratory and reporting requirements: The laboratory must meet CLIA accreditation and licensing requirements and provide specified test-result reporting and consultation contacts. The assays are described as FDA-approved genetic blood tests. - Sensitive information: VA sensitive PII/PHI is involved. The PWS states that a business associate agreement (BAA) is not required under the health-care-operations exception. - Period: March 1, 2027 through February 29, 2032; the anticipated five-year IDIQ includes five one-year task order periods. - Vendor submissions: Interested parties may submit capability statements and requested company, experience, socioeconomic-status, teaming, contract, and pricing information by October 12, 2026, at 10:00 AM Pacific Time. - Value: No contract value is stated. The range below is an estimate, not a Government-provided amount.

Description

This is an INTENT TO SOLE SOURCE NOTICE only. This is an intent to sole source notice for commercial items prepared in accordance with FAR RFO Subpart 5.1, Presolicitation. This announcement constitutes the only notice of intent to sole source and synopsis of proposed action. The Department of Veteran Affairs, Network Contracting Office (NCO) 21, intends to issue a sole-source contract under the authority of this non-competitive acquisition as implemented by 41 U.S.C 253(c) (1) FAR RFO 6.103-1 (only one responsible source and no other supplies or services will satisfy agency requirements), to CareDx. We believe there are no authorized third-parties that can provide the proprietary AlloMap® gene expression profiling and AlloSure® donor-derived cell-free DNA (dd-cfDNA) assays to satisfy this requirement. Services will include a five (5) year IDIQ ordering period contract.

This notice of intent is not a request for quotations; interested parties may express their interest by providing a capability statement and returning it to Cynthia.Diezel@va.gov no later than 10:00 AM PST on 10/12/26. When responding to this announcement, respondents should refer to number 36C26127Q0083, Notice of Intent in the subject line. A determination not to compete this proposed contract upon responses to this notice is solely within the discretion of the Government. Verbal and facsimile responses are not acceptable and will not be considered. All interested parties are reminded to be registered with System for Award Management (SAM) at https://sam.gov/SAM/ in order to be eligible for award of Government contracts. No telephone calls will be accepted. If after 10/12/26 at 10:00 AM PST, no viable responses have been received in response to this announcement, NCO 21 shall negotiate solely with CareDx. The applicable NAICS Code is 621511 and the size standard is $41.5M. Vendors must show they can provide services as described in the attached Description of Services. Failure to complete the questions below will be considered non-responsive and will not be considered a viable source. The Government anticipates the award of a firm-fixed-price contract. A determination by the Government whether to compete the proposed requirement shall be based upon responses received and is solely within the discretion of the government. Information received shall be considered solely for the purpose of determining whether to conduct a competition. Estimated Period of Performance (POP): 03/01/2027 2/29/2032. Contract will be inclusive of five (5) one-year task order periods. Must answer the following questions if your company decides to respond: What is your company s Socioeconomic Status? (ex: small business, large business, SDVOSB, etc.) a. If SDVOSB or VOSB, are you registered in Vendor Information Pages (VIP)?
https://www.vip.vetbiz.va.gov/ Provide Company s legal name along with SAM UEI.

Capabilities Statement

List of Projects (Government and Commercial) that are similar in scope and size.

Anticipated Teaming Arrangements (if any). If plan on subcontracting, demonstrate that you will meet the limitations on subcontracting per FAR 52.219-14 for Small Businesses; VAAR 852.219-74 for SDVOSB/VOSB.

GSA Contract Number, if applicable.

Provide an estimate price for base year plus four option years.

RFI number 36C26127Q0083 has been assigned and should be referenced on all correspondence regarding this announcement.

See attached document: Description of Services.

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