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RECOVERY - ST10-1078 for an initiative called "Basic Ordering Agreement (BOA) in Support of the Clinical Assay Development Network (CADN) to Facilitate Development and Validation of Clinical Assays"

This opportunity is a Recovery and Reinvestment Act action
Solicitation Number: ST10-1078
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Cancer Institute
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ST10-1078
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Combined Synopsis/Solicitation
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Added: Jun 11, 2010 2:55 pm
SAIC-Frederick, Inc. (SAIC-F) in support of the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD) intends to solicit proposals under Solicitation Number RECOVERY - ST10-1078 for an initiative called "Basic Ordering Agreement (BOA) in Support of the Clinical Assay Development Network (CADN) to Facilitate Development and Validation of Clinical Assays".

ALL OFFERS MUST BE RECEIVED BY 2 PM (EDT) ON JULY 23, 2010, AND ALL QUESTIONS OR REQUESTS FOR CLARIFICATIONS MUST BE EMAILED TO THE POINT OF CONTACT NO LATER THAN 12 PM (EDT) ON JUNE 25, 2010.  NO TELEPHONE CALLS WILL BE ACCEPTED.

The Clinical Assay Development Network (CADN) is a new program being initiated by the NCI's Division of Cancer Treatment and Diagnosis (DCTD) to facilitate development and validation of clinical assays. Comprehensive characterization of individual tumors promises to change the practice of medicine. This effort is being spurred by advances in our understanding of the biology of cancer and in the tremendously enabling technologies derived from the Human Genome Project. The timely translation of molecular findings to effective clinical tools will depend on the ability to rapidly evaluate the clinical relevance of molecular alterations observed in tumor specimens and to develop and technically validate assays to detect these alterations that can be used in the clinical setting.

Significant amounts of data will be generated by the Patient Characterization Center, as well as in the cancer research community, that will be evaluated to determine which alterations found in human tumors are associated with clinical parameters of interest such as subclass of disease, risk of progression or likelihood of response to therapy. These data are expected to lead to development of new assays with the potential to guide clinical decision-making. The assays will be evaluated in both retrospective and prospective settings.

Assays that will be used for clinical decision-making must meet criteria of performance such as those set out in guidance documents of the FDA and/or those recently published by the Strategy Group of the Program for the Assessment of Clinical Cancer Tests (PACCT) for integral assays in clinical trials http://www.cancerdiagnosis.nci.nih.gov/scientificPrograms/pacct/PACCT_Assay_Standards_Document.pdf . Participants in the CADN will partner with various programs in DCTD and other components of the NCI and their extramural partners to optimize and technically validate assays that are proposed for inclusion as integral components of phase III and large phase II clinical trials; to optimize and technically validate assays proposed as integrated assays in trials; and potentially to collaborate with investigators with research grade assays to assist in early stage clinical assay development. A Clinical Assay Development Center (CADC) is being established at NCI. Together the CADC and the CADN will create a process to efficiently develop diagnostic tools that will address clinical needs, including (but not limited to) markers of prognosis, patient selection for co-development with targeted agents and prediction of response. Initially, the emphasis will be on evaluating the performance characteristics of assays proposed for use in clinical trials. The CADC and CADN will provide the resources to carry out the necessary assay, optimization and technical validation. Project teams including pathologists, statisticians and experts in assay development will be formed to identify services required, to design the assay specific studies.


To meet the needs of planned clinical assay development activities, SAIC-F is seeking the services of clinical laboratories with demonstrated expertise, infrastructure and resources necessary to validate clinical assays. This shall include experience in assay development, optimization, technical validation, demonstration of assay clinical performance, and preparation of detailed datasets and SOP's. . The contracted laboratories will have to be CLIA-certified. The laboratories shall have to have expertise in one or more of the following technologies: immunohistochemistry, ELISA, in situ hybridization, quantitative Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR), quantitative PCR, and DNA sequencing. Additional technologies may be required in the future and they would be included in subsequent solicitations.


The objective of this statement of work (SOW) is to describe the requirements for the CADN which will be established through the BOA under which future task orders will be issued to acquire services targeted for specific CADN supported projects.


Task orders issued under this BOA shall request the subcontractor to provide specific services to meet the needs of separate studies requested and/or directed by specific customers to be conducted by the CADN over the life of the task order.


SAIC-F will engage with Offerors that have demonstrated clinical laboratory expertise, infrastructure and resources necessary to validate clinical assays including experience in assay development, optimization, technical validation, demonstration of assay clinical performance, and preparation of detailed datasets and SOP's. Specifically, Offerors laboratories must be CLIA certified and the laboratories must have expertise in one or more of the following technologies:


Immunohistochemistry
ELISA
In situ hybridization
Quantitative ReverseTranscriptasePolymeraseChain Reaction (RT-PCR)
Quantitative PCR
DNA sequencing


Additional technologies may be required in the future and would be requested in subsequent task order solicitations.

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RFP ST10-1078

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
RFP ST10-1078
Posted Date:
June 11, 2010
Description: RFP ST10-1078

Amendment 1

Type:
Mod/Amendment
Posted Date:
July 2, 2010
Description: Amendment No. 01 Questions and Answers to RFP ST10-1078 CADN BOA
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Bldg 427, Room 12
Frederick, Maryland 21702
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Work will be performed at Subcontractor facilities.

United States
:
Kimberly A Iman,
Sr. Subcontracts Specialist
Phone: (301) 228-4033
Fax: (301) 228-4037
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Jennifer Thomas,
Sr. Subcontract Specialist
Phone: 301/228-4004
Fax: 301/228-4037