SOLICITATION NOTICE
B -- Oncotype Dx Testing Services
- Notice Date
- 8/3/2009
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90146-MM
- Archive Date
- 8/27/2009
- Point of Contact
- Melissa P Marino, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
marinome@mail.nih.gov, cr214i@nih.gov
(marinome@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD), Cancer Diagnosis Program (CDP) plans to procure on a sole source basis Oncotype Dx Testing Service for TAILORx Trial in Breast Cancer with Genomic Health, Inc. (GHI), 301 Penobscot Drive, Redwood City, CA 94063 This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System Code is 325412 and the business size standard is 750 employees. Only one award will be made as a result of this solicitation. Period of Performance: Performance shall be for one base year with one (1) twelve month option period. The NCI DCTD provides support to the Clinical Cooperative Groups to conduct a large trial of patients with early stage breast cancer. The trials will test whether patients with a Recurrence Score between 11-25 as determined by the Oncotype Dx assay will benefit from addition of chemotherapy to hormonal therapy. The The Trial Assigning Individualized Options for Treatment (TAILORx) was initiated in late 2005 and has been rapidly accruing patients. The contractor shall provide Oncotype Dx assay on approximately 4000 patients required to complete enrollment in this important trial. The contractor shall perform the following: 1. OncotypeDx on all patients who are pre-registered to the TAILORx trial. The test will be ordered by the treating physician using standard GHI ordering procedure and forms. TAILORx is designed to use the OncotypeDx to select lymph node-negative, hormone receptor-positive breast cancer patients for treatment that will be tailored according to their risk of recurrence, as measured by the test. There is no other equivalent test. GHI is the only CLIA (Clinical Laboratory Improvement Act of 1988) certified laboratory performing the test.Genomic Health, Inc. has carried out the Oncotype Dx Assay on all patients enrolled in the TAILORx Trial to date. They are the only source for the performance of the Oncotype Dx Assay which they perform in a CLIA (Clinical Laboratory Improvement Act of 1988) certified laboratory. GHI's performance has been excellent. They have achieved assay results on greater than 99% of the patients specimens provided to them. They have also provided the data back to the physician enrolling the patient on the trial rapidly so that the patients can receive proper treatment in a timely fashion. The Oncotype Dx assay is a proprietary assay of GHI. They spent years developing and technically and clinically validating the assay. The have proprietary nucleic acid probes, reagents and analytical algorithms for determining the risk of node negative breast cancer patients of disease progression. This is not an off the self assay. Assays that are being used to make decisions about patient treatment must be technically and clinically validated and must be run in a CLIA certified laboratory. Only laboratories that have demonstrated proficiency with the assay can perform it in the context of patient management. Since this is a proprietary assay, no on else can perform the Oncotype Dx assay. Without support for the performance of the Oncotype Dx Assay by GHI the TAILORx trial with have to be terminated far short of its accrual goals. Termination of this high profile clinical trial would result in a failure to realize the benefit from the significant investment already made in the trial. Termination at this time would leave significant uncertainty about the appropriate clinical use of the Oncotype Dx Assay. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI contracting office on or before 11:00 AM EST on August 12, 2008. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Melissa Marino, Contract Specialist at marinome@mail.nih.gov. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference solicitation number NCI-90146-MM on all correspondences.
- Web Link
-
FBO.gov Permalink
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- Record
- SN01897383-W 20090805/090804000022-c7bf065871a04693e70d2ac9c3e07430 (fbodaily.com)
- Source
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