Q301--FY27 Oncotype DX Genomic Cancer Assay Testing Services

The Department of Veterans Affairs, Network Contracting Office 21, intends to award a sole source contract to Genomic Health, Inc. for Oncotype DX genomic testing services for breast, colon, and DCIS cancers, including all associated specimen kits, analysis, interpretation support, reporting, and consultation. This action is justified under FAR 6.302-1, citing that Genomic Health is the only responsible source capable of meeting the agency’s unique requirements for these specific genomic assays. The contract falls under NAICS code 621511 for Medical Laboratories with a $41.5 million SBA size standard and uses the Product and Service Code Q301. Performance is expected to support the Sierra Nevada Health Care System, with all specimen handling, analysis, and reporting conducted according to strict CLIA '88 standards. The contractor must provide all necessary supplies including specimen containers, carriers, preservatives, requisition forms, and current test reference materials. Personnel must hold current certifications, and laboratory directors must be board-certified pathologists or appropriately certified bio-analysts with documented clinical experience. All testing must adhere to stringent reporting timelines: routine results within 24 hours, STAT tests within two hours, and critical values immediately. Unsatisfactory specimens must be clearly flagged. The Government retains full ownership of all generated data, records, and electronic systems, and the contractor is prohibited from retaining, using, selling, or disseminating any patient or test information without explicit VA authorization. Patient lists and medical data are privileged and protected under the Privacy Act and Freedom of Information Act. Payments will be made monthly in arrears through the Department of Veterans Affairs Financial Services Center in Austin, Texas, with no advance payments permitted. Invoices must be submitted electronically via Tungsten/OB10 and must include the contract number, dates of service, number of slides processed, unit price, total cost, and contact information for invoice inquiries. Supporting documentation and invoices must be delivered no later than the 20th workday of the month, and all outstanding invoices must be submitted within 30 days after contract conclusion. The Contracting Officer’s Representative will verify invoice accuracy against daily logs of processed specimens. Professional liability insurance is mandatory, and the contractor must comply with all applicable OSHA, federal, and state safety regulations. No security accreditation is required. Responses to this notice of intent must provide clear, compelling, and convincing justification that competition would benefit the government; however, no awards will be made based on uns