36C24920Q0001-001.docx

Statement of Work Specialized Cancer Testing 626-20-1-097- COR: Shannon Skillern, 615-873-7589 Shannon.skillern@va.gov Requirements:

1. Requirements

TVHS needs a vendor to perform the following special cancer tests: Brand Named or Equal to Oncotype DX Breast Cancer Assay and the Oncotype DX Prostate Cancer Assay, which are trademarked tests by Genomic Health. The required testing will analyze the activity of a group of genes that can affect how a cancer is likely to behave and respond to treatment. Testing results need to show how complex genes are expressed in cells (what their level of activity is), and the role they play in specific cancers including breast, colon, and prostate.

TVHS will only accept tests of equivalent or higher performance to the Oncotype DX test. Equivalent tests must show clinical evidence and at least three years on the market in labs (outside of research purposes). The VA TVHS requires testing that has been reliable for years and will not risk experimenting with newer specialized cancer tests unless evidence guarantees greater benefits to Veterans.

The requested tests have been proven to predict the likelihood of cancer recurrence, the likelihood of patient survival and the likelihood of chemotherapy benefit. These unique diagnostic tests can help patients and their doctors make informed, individualized treatment decisions. Results will also help clinicians determine if the patient needs to undergo chemotherapy treatment or not, saving the VA thousands of dollars in treatment costs.

2. Scope.

Indefinite delivery, indefinite quantity (IDIQ) of cancer testing, with the required tests listed in the chart under “Specific Tasks.” If possible, a base plus four contract would be ideal.

List Price*

Quantity Contract Rate

Total

Oncotype DX Breast billing code S3854

Oncotype DX Prostate billing code 84999

3. Specific Tasks (Evaluation Factors).

The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient testing to aid in the treatment of cancer. Estimated quantities of tests will depend upon patient specifics.

Vendor must offer all tests listed in the test menu below.

TEST MENU:

Following brand name or equal tests must be available from vendor

Oncotype DX Breast Cancer Assay

Oncotype DX Prostate Cancer Assay

4. Performance Monitoring Performance monitoring will be done by a third party, the organization that the reference lab has accreditation through. The reference lab will maintain on file their current accreditation and make it available for review upon request.

5. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

None

6. Other Pertinent Information or Special Considerations.

1. Identification of Possible Follow-on Work. NA

1. Identification of Potential Conflicts of Interest (COI). All parties involved with the review and establishment of this request should not have any conflicts of interest with the chosen vendor.

1. Identification of Non-Disclosure Requirements. NA

1. Packaging, Packing and Shipping Instructions. As indicated on requisition form, or on posted test preparation guidelines.

1. Inspection and Acceptance Criteria. See performance monitoring

7. Risk Control

NA

8. Place of Performance.

Reference Laboratory.