Q301--DONOR-DERIVED CELL FREE DNA TESTING KITS

Solicitation / RFP / RFQ

This document is a combined synopsis/solicitation for commercial products and services, specifically for comprehensive, full-service Kidney Donor-Derived Cell-Free DNA (dd-cfDNA) Testing. The James J. Peters VAMC in Bronx, NY, requires these services to support its Renal Transplant Program, aiming to enhance post-transplant surveillance for kidney transplant recipients by enabling early detection of allograft injury or immune activation.

• Provision of specimen collection kits.

• Secure, trackable, and temperature-controlled transport of specimens from NYVA to the testing laboratory within 48 hours of collection.

• dd-cfDNA testing using CPT code 81479 in a CLIA-certified and CAP-accredited laboratory.

• Delivery of reliable and accurate test results within 72 hours of specimen receipt.

• Secure transmission of test results via fax or encrypted email, complying with HIPAA and PHI standards.

• Provision of training and clinical interpretation support to VA staff upon request.

• Maintenance of chain-of-custody documentation for all shipments.

• Development and adherence to a Quality Control Plan (QCP).

• Contract Type: Indefinite Delivery/Indefinite Quantity (IDIQ), Firm-Fixed-Price (FFP).

• IDIQ Minimum: $1,000.

• IDIQ Maximum: $600,000.

• Period of Performance: Five (5) years.

• Estimated annual testing volume: 30 to 45 dd-cfDNA tests per year.

• Submission Deadline: February 20, 2026, by 10:00 AM EST.

• Evaluation Factors: Technical Capability, Past Performance, and Price.

• Technical Capability will assess understanding of requirements, specimen handling, testing procedures, laboratory qualifications (CLIA/CAP), quality control, and training support.

• Past Performance will be evaluated based on relevance, recency (last 3 years), and quality of performance.

• Price will be evaluated for reasonableness and completeness.

• Offers must include a statement of agreement with terms and conditions or list exceptions.

• NAICS Code: 621511 Medical Laboratories.

• Small Business Size Standard: $41.5 Million.

• This is a Full and Open competition.

• Questions due by: February 12, 2026, by 10:00 AM EST.

• Point of Contact for questions: Mariangie Rivera at Mariangie.Rivera@va.gov.

• Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for comprehensive donor-derived cell-free DNA (dd-cfDNA) testing kits and laboratory services. The James J. Peters Bronx VA Medical Center (JJP VAMC) requires these services to support the Renal Transplant Program, specifically for post-transplant surveillance for kidney transplant recipients.

• Donor-derived cell-free DNA (dd-cfDNA) testing kits.

• Laboratory services to support dd-cfDNA testing.

• Services are for post-transplant surveillance for kidney transplant recipients.

• The document does not specify contract type, period of performance, or estimated value.

• Response Date/Time/Zone: 02-20-2026 10 AM EASTERN TIME, NEW YORK, USA.

• The document does not detail evaluation criteria or factors.

• The document does not specify any set-aside or eligibility requirements.

• Solicitation Number: 36C24226Q0287

• Contracting Office: NCO 2, Department of Veterans Affairs, Samuel S. Stratton VA Medical Center, Albany NY.

• Place of Performance: James J. Peters VA Medical Center, Bronx NY 10468.

• Point of Contact: Mariangie Rivera, Mariangie.Rivera@va.gov, 518-626-6246.

• Product Service Code: Q301

• NAICS Code: 621511