Q301--Multiple Sclerosis Disease Activity Testing John D. Dingell VA Medical Center

The Department of Veterans Affairs, through the Network 10 Contracting Office, has awarded a sole-source contract to Octave Bioscience, Inc. for proprietary Multiple Sclerosis Disease Activity (MSDA) blood biomarker testing services under solicitation 36C25026Q0548. This procurement, conducted under FAR 13.106-1(b)(2) as a simplified acquisition, relies exclusively on the unique, patented 18-biomarker assay developed by Octave Bioscience, which provides a serum-based disease activity score and pathway-specific sub-scores to guide clinical decisions on Disease Modifying Therapy for Veterans at the John D. Dingell VA Medical Center in Detroit, MI. The contract includes a 12-month base period with an estimated value of $70,000 at a unit price of $1,349 per test, with no guaranteed minimum volume, and option periods to be determined. Testing is performed at Octave’s CLIA-certified laboratory in Menlo Park, CA, while specimens are collected at the VA facility, with results securely delivered to VA clinicians. Contract performance is governed by strict compliance with HIPAA and CLIA regulations, with the contractor responsible for specimen handling, assay accuracy, timely reporting, and continuous regulatory credentialing. The VA retains responsibility for specimen collection, labeling via Test Requisition Forms, and clinical use of results. Invoicing requires detailed elements including Veteran identifier, date of service, quantity, unit price, and total cost, to be submitted through VA’s authorized payment system. No competitive evaluation process was applied due to the proprietary nature of the technology, which precludes alternative sources. The contractor must adhere to VA quality review processes, submit corrective actions for discrepancies, and notify the agency of any methodological or regulatory changes. There are no specific packaging, marking, barcoding, or MIL-STD requirements outlined; instead, the contractor provides specimen handling and preservation protocols. Point of contact for contract administration is Contracting Officer Cierra S. Joshua, and no separate COR, COTR, or security clearance requirements exist beyond mandatory privacy compliance. The contract falls under NAICS 541380 and PSC 6640, with no Recovery Act funds utilized.