Q301--FY27 Oncotype DX Genomic Cancer Assay Testing Services

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide laboratory services for the VA Northern California Health Care System (VANCS), specifically for Oncotype DX testing, a cancer assay used to predict patient benefit from chemotherapy for breast and colon cancers, and for DCIS breast cancer risk assessment.

• The contractor shall provide laboratory services including pre-analytic processing, analysis, reporting of analytic results, and consultation regarding test selection, collection, transportation, and result interpretation.

• The contractor must supply all necessary supplies, including requisition forms, specimen containers, special instructions, test lists with reference ranges, specimen carriers, and all other required forms.

• Special preservatives for specimen preservation must be supplied by the contractor.

• Analysis of samples will be performed by the contractor.

• Routine test results must be reported within 24 hours of testing; STAT test results within 2 hours; and Critical Value test results immediately.

• The contractor shall provide a means of communication for immediate inquiry regarding the status of pending tests.

• Billing and test report summaries are required monthly.

• Routine test results: within 24 hours of testing.

• STAT test results: within 2 hours or less of testing.

• Critical Value test results: reported immediately.

• Reports must be in duplicate and received by remote terminal where applicable.

Not explicitly stated in the provided text, but implied to be for the VA Northern California Health Care System.

• Licensing and Accreditation: Contractor must possess all legally required licenses, permits, accreditations, and certificates. Accreditation by CDC under CLIA is required if engaged in interstate commerce. The Laboratory Director must be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.
• Personnel Qualifications: Employees must have current and valid professional certifications. Technologists, medical technicians, and cytotechnologists must meet CLIA '88 Guidelines. Pathologists must meet specific educational, residency, and licensing requirements, with minimum experience in pathology and consultation services.
• Records Management: Contractor must comply with Federal and Agency records management policies, including safeguarding records covered by the Privacy Act and Freedom of Information Act. All deliverables are property of the U.S. Government. No disposition of documents without Contracting Officer approval.
• Patient Confidentiality: Patient lists and medical information are privileged and shall not be disclosed outside the VA without prior written authorization.
• Professional Liability Insurance: Contractor must maintain professional liability insurance.
• Billing/Invoices: Invoices must be submitted monthly in arrears, electronically via Tungsten/OB10 e-Invoice, no later than thirty (30) days after the contract period end. Invoices must include specific details such as dates of service, number of slides processed, unit price, total cost, contract number, and remittance address. Supporting documentation is due by the 20th workday of the month.
• Safety: Compliance with all applicable OSHA, Federal, and State laws and regulations is required.
• Security: C&A requirements do not apply; a Security Accreditation Package is not required.

Solicitation / RFP / RFQ

This is a Notice of Intent (NOI) to award a sole source contract for Oncotype DX genomic cancer assay testing services. The Department of Veterans Affairs (VA) Sierra Nevada Health Care System (VASNHCS) intends to award this contract to Genomic Health, Inc. The services include genomic testing for breast, colon, and DCIS cancers, encompassing specimen kits, analysis, interpretation support, reporting, and consultation services.

• Oncotype DX Breast genomic testing

• Oncotype DX Colon genomic testing

• Oncotype DX DCIS genomic testing

• Specimen kits

• Analysis, interpretation support, reporting, and consultation services

• The contract will be a sole source award.

• Authority cited: Federal Acquisition Regulation (FAR) Part 6.302-1, "Only one responsible source and no other supplies or services will satisfy agency requirements."

• This notice is NOT a formal solicitation or request for competitive proposals.

• No solicitation document is available.

• Unsolicited quotations or offers received in response to this notice will not result in an award.

• Any responses must provide clear, compelling, and convincing evidence that competition would be advantageous to the Government.

• The government's determination to compete this action is at its sole discretion.

• NAICS Code: 621511 – Medical Laboratories

• SBA Size Standard: $41.5 Million

• Product and Service Code: Q301 – Medical, Reference Laboratory

• The intended contractor is Genomic Health, Inc., located at 301 Penobscot Dr., Redwood City, CA, 94063.

• All inquiries must be submitted in writing via email to Wayne Geschwindt (wayne.geschwindt@va.gov) with "36C26126Q0838 Oncotype DX Genomic Cancer Assay Testing Services" in the subject line.

• Response Date/Time/Zone: 06-25-2026 10:00 PACIFIC TIME, LOS ANGELES, USA.