SOLICITATION NOTICE
B -- Specimen Preparation for the BCR-ABL Assay Standardization Project
- Notice Date
- 6/16/2008
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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-80094-MM
- Archive Date
- 7/15/2008
- 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
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), National Cancer Institute (NCI), Cancer Diagnosis Program (DCP) intends to procure on a sole-source basis with Fred Hutchinson Cancer Research Center (FHCRC), 1124 Columbia St., C2-023, Seattle, WA 98104 for services regarding specimen preparation for the BCR-ABL Assay Standardization Project. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System Code is 541690 and the business size standard is $6.5M Period of performance: Performance shall be from date of award through September 30, 2008. The Cancer Diagnosis Program (CDP) supports the development and evaluation of molecular diagnostics for clinical practice. Acceptance by clinicians of the BCR-ABL assay for Chronic Myelogenous Leukemia (CML) is limited by the lack of standardization among the American laboratories that perform the assay. The assay uses quantitative RT-PCR, and despite being performed in CLIA-certified laboratories, one laboratory's results cannot be directly compared to another's. Currently many American laboratories perform this assay using different protocols and different control genes. There are no commonly used calibrators to standardize the assay. This contract will support preparation of specimens and calibrators to be used by other laboratories to assess whether use of a uniform RNA calibrator improves standardization of this assay. The contractor must have access to a large collection of clinical samples and have created a unique RNA calibrator for the BCR-ABL assay for CML. The calibrator must be stable in Trizol when mixed with normal reference RNA and be able to quantify the number of BCR-ABL transcripts per µg of RNA extracted from peripheral blood of patients with CML. The contractor must be able to perform the BCR-ABL assay on peripheral blood in a CLIA-certified laboratory with CLIA-certified procedures and protocols. The contractor must also be able to provide the number of samples and calibrators specified by the NCI in Trizol solution, code them according to the NCI-supplied study design and distribute them with the appropriate protocols and procedures for storing and handling the specimens to the testing laboratories as specified by the NCI and. The contractor must measure the BCR-ABL levels in the specimens prior to distribution and as the testing laboratories are finishing their second batch of assays in their CLIA-certified laboratory as directed by the NCI. The FHCRC is internationally recognized as a sole resource for this study because of the laboratory's expertise on the BCR-ABL assay for CML in America. The FHCRC has access to a large collection of clinical samples and one of the few CLIA-certified laboratories that has access to the numbers of specimens required for this study. The FHCRC has strong support for the standardization of the BCR-ABL assay and creation of a unique RNA calibrator that will be assessed as an external standard for this assay. Thus, the FHCRC is the pre-eminent American institution for standardizing this assay. The FHCRC and the CLIA-certified laboratory of Dr. Radich are uniquely qualified to perform the tasks required to support this initial phase of standardizing the BCR-ABL assay. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the above requirement, they may submit a statement of capabilities. All information furnished shall 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 by 1:00 PM EDT on June 30, 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. It is the vendor's responsibility to call (301) 402-4509 to verify questions have been received. 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/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 NCI-80094-MM on all correspondence.
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- Record
- SN01594630-W 20080618/080616220720-7780812fba2353cf3ace4c14b2dc888d (fbodaily.com)
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