SOLICITATION NOTICE
H -- OncotypeDx Testing Services
- Notice Date
- 7/26/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-50100-NV
- Response Due
- 8/5/2005
- Archive Date
- 8/20/2005
- Description
- The National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD) plans to procure on a sole source basis OncotypeDx Testing Services for TAILORx Breast Cancer Trial from Genomic Health, Inc. 301 Penobscot Drive, Redwood, CA 94063. For a one year base period with two one year options. The supplies and services herein are commercial as defined in FAR Part 2, and this acquisition is being made in accordance with the test program for using simplified procedures for certain commercial items as authorized in FAR Part 13. The North American Industry Classification Code is 541380 and the business size standard is $10million. The DCTD is supporting the Clinical Cooperative Groups to conduct a large trial involving patients with early stage breast cancer. The trial will test whether patients whose Recurrence Score (RS), as measured by the OncotypeDx assay, falls in the range from 11-25 benefit from the addition of chemotherapy to hormonal therapy. The OncotypeDx assay (Genomic Health, Inc.), an RT-PCR expression profile, has been shown to reliably predict the risk of recurrence in patients with node negative, hormone receptor positive breast cancer (N Engl J Med. 351:2817-26, 2004). The Trial Assigning IndividuaLized Options for Treatment (TAILORx) is designed to use a molecular analysis tool the OncotypeDx to select lymph node-negative, hormone receptor-positive breast cancers for treatment that will be tailored according to their risk of recurrence, as measured by the test. Approximately 1200 patients will have to be tested to identify 4800 with an intermediate RS. The TAILORx trial is specifically designed to use the OncotypeDx test because this is the only test that has been standardized and evaluated in appropriate specimens from randomized clinical trials. There is no other equivalent test. This test is performed in only one place, the CLIA (Clinical Laboratory Improvement Act of 1988) certified laboratory of Genomic Health, Inc. (GHI). The OncotypeDx test is not a kit that can be purchased to be performed in any clinical laboratory. Therefore, GHI is the only source for the performance of the OncotypeDx test. This is not a request for competitive quotation. However, if any interested party believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform this requirement. An original and one copy of the capability statements must be received in the contracting office by 1:00 PM EDT, August 5, 2005. Faxed and emailed capability statements are NOT authorized. If you have any questions they must be submitted in writing to Deborah Moore, Contract Specialist, at dm170b@nih.gov or by fax 301-402-4513. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Reference number NCI- 50100-NV must be stated on all correspondence. No collect calls will be accepted.
- Record
- SN00854640-W 20050728/050726211901 (fbodaily.com)
- Source
-
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