Q301--CAREDX Post heart transplant rejection surveillance tests
Closed Special Notice Posted
- Solicitation number
- 36C26127Q0083
- Agency
-
Veterans Integrated Service Network 21
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 621511 Medical Laboratories
- PSC
- Q301 Reference Laboratory Testing
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21 issued a notice of intent to sole-source a five-year IDIQ contract to CareDx for post-heart transplant rejection surveillance testing, with a capability statement deadline of October 12, 2026, at 10:00 AM PST; interested parties may challenge the sole-source rationale by that date.
The VA determines that CareDx is the only responsible source capable of providing the proprietary AlloMap gene expression profiling and AlloSure donor-derived cell-free DNA assays required to monitor veteran heart transplant patients for rejection without invasive biopsy. VA Palo Alto anticipates ordering approximately 100 AlloMap tests and 65 AlloSure tests annually. The contractor must maintain CLIA accreditation, employ qualified personnel including a licensed pathologist or certified bio-analyst as laboratory director, and conduct testing Monday through Friday, 8:00 AM to 4:30 PM, at the Brisbane, California laboratory location. All testing supplies and services, including mobile phlebotomy, specimen containers, and chain-of-custody forms, must be provided by the contractor. Results must be reported in duplicate with specified data elements. The contract runs from March 1, 2027, through February 29, 2032. The contractor must comply with VA information security, privacy, and data protection requirements including FIPS 140-2 encryption, incident reporting within one hour, annual security assessments, and Rules of Behavior training. Electronic invoicing must be submitted via VA's OB10 system or X12 EDI format no later than the 20th workday of the following month. Respondents must be registered in SAM; verbal, facsimile, and telephone responses are not acceptable. If no viable capability statements are received by the deadline, the VA will negotiate directly with CareDx.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| CareDX AlloMap Allosure PWS.doc | DOC document | |
| 36C26127Q0083.docx | DOCX document |
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