J and A Redacted.pdf

This document is a Sole Source Justification and Approval (J&A) for a non-competitive contract procurement by the Medical Readiness Contracting Office-West. The Brooke Army Medical Center (BAMC) Department of Pathology is seeking a highly specialized laboratory testing service from a single FDA-cleared in vitro diagnostic (IVD) provider to detect minimal residual disease (MRD) in bone marrow samples from patients with multiple myeloma and leukemia. The contract will be a Firm Fixed Price (FFP) using Defense Health Program (DHP) funds, with a base period plus four option years.

A sources sought notice was posted from 15 January 2025 to 07 February 2025, which received two responses. After technical review, only one vendor was determined to be technically capable of meeting the specific requirements. The selected vendor offers the first and only FDA-cleared assay for MRD monitoring in lymphoid cancers, with the ability to detect minute levels of cancer cells (as low as one cancer cell in a million normal cells). BAMC domain experts will continue to conduct market research and solicit input from the laboratory community on emerging testing capabilities in the coming option years.