SOLICITATION NOTICE
Q -- Procurement of Biosamples for collection of primary tumors, metastatic lesions and normal tissue and residential history from Greek subjects for genome-wide methylation analysis
- Notice Date
- 8/14/2017
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP72651-76
- Archive Date
- 8/25/2017
- Point of Contact
- Catherine Muir, Phone: (240) 276-5434
- E-Mail Address
-
muirca@mail.nih.gov
(muirca@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, UNITED STATES. Description: National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Integrative Tumor Epidemiology Branch (ITEB), plans to procure on a sole source basis biosample collection services from the National and Kapodistrian University of Athens; 6 Christou Lada; Athens, Greece, 10561. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 621511 and the business size standard is $32.5M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The Period of Performance is estimated to be twelve (12) months from the date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The mission of the DCEG is to conduct broad-based, high quality, high impact research to uncover the causes of cancer and the means of its prevention. The DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies, and other appropriate bodies. The Division develops research resources and strategic partnerships in molecular epidemiology across NCI, NIH, and the global research community. The Division holds as its top priority the training and development of the next generation of scientists in cancer epidemiology and related fields. The mission of ITEB is to advance understanding of cancer etiology and progression through integrative analyses of environmental and germline risk factors with comprehensive data on histological and molecular profiling of tumors and their precursors, including somatic genomic analyses. The branch also develops methods to support this cutting-edge research. The purpose of this procurement is to fund the collection of tissue specimens including melanoma tumors, normal tissue from resection and metastatic lesions ("TRIOS") from the same Mediterranean subjects that have GWAS data analyzed at NCI. This work will include the identification of TRIOS from subjects with GWAS data, fill-in a pathology manifest prepared by NCI to collect all pathological features of the melanoma tumors identified, and sectioning of 7 slides from each tissue block (3 blocks per person). The original pathology report should accompany the material. Moreover, the personal history of residence from the subjects who were enrolled in the genome-wide association study should be provided for the analysis. Aberrant DNA methylation is an epigenetic hallmark of melanoma, and many studies suggest it plays an important role in both melanoma formation and progression. Recent advances in genome-wide methylation methods have provided the means to rapidly identify differentially methylated genes, methylation signatures, and potential biomarkers in melanoma. In particular, several studies have suggested that distinct methylation subgroups exist within melanoma and are associated with distinct biologic behavior and survival outcomes, particularly in susceptible individuals. Sun exposure may change the methylation levels and modify the clinical outcomes. The NCI has conducted a series of genome-wide association studies (GWAS) to identify genetic loci that increase susceptibility to melanoma in Mediterranean countries, including Italy, Spain and Greece. From the subjects with GWAS data, NCI needs to collect tissue specimens including melanoma tumors, normal tissue from resection and metastatic lesions ("TRIOS") from the same subjects. The DNA extracted from the tissue specimens will undergo methylation analysis to study the role of methylation in melanoma progression from primary tumor to metastatic lesions. Moreover, NCI needs to collect information on personal history of residence for the case-control subjects that were included in the genome-wide association study to link their residence to ambient UV exposure. Contractor shall perform the following: The Contractor, as an independent agent and not as an agent of the Government, shall furnish all necessary qualified personnel, materials, equipment, supplies, and facilities not otherwise provided by the Government as needed to perform the technical requirements below. 1. Identify the tissue blocks from subjects with GWAS data, and tissue specimens from primary tumor, metastatic lesions and normal tissue. It is estimated that the National and Kapodistrian University of Athens School of Medicine will identify twenty-eight (28) subjects with corresponding (84) tissue blocks (TRIOS) 2. Fill in an excel file manifest provided by the NCI to collect pathology information from each tissue blocks 3. Section seven (7) slides from each tissue block following the order outline below: a. One (1) stained slide of five (5) micron thickness from top of block for diagnostic review, followed by b. Three (3) unstained slides of ten (10) micron thickness for DNA extraction, followed by c. One (1) stained slide of five (5) micron thickness for additional diagnostic review of material, followed by d. Two (2) unstained slides of ten (10) micron thickness for DNA extraction 4. Collect residential history for every melanoma case and control from Greece included in the genome-wide association study ((800) melanoma cases and (800) controls) 5. Provide a monthly report (contents of report to be coordinated with the NCI Technical Point of Contact) on the progress of the activities to the NCI Technical Point of Contact via email It is expected that the center will exercise the above listed requirements for twenty-one (21) tissue blocks from seven (7) patients and residential history data for (400) subjects (cases and controls) every four (4) months for a total of (84) tissue blocks from twenty-eight (28) subjects and residential history data for (1,600) subjects Government Responsibilities: At the time of the award, the NCI technical point of contact will coordinate delivery of the material to be evaluated for DNA extraction and quality control procedures. The NCI Technical Point of Contact will send the manifest to collect pathology features from the selected tissue blocks. Reporting Requirements and Deliverables: 1. Every four (4) months the Contractor shall provide the following material via email corresponding to twenty-one (21) specimens to the NCI Technical Point of Contact: a. An electronic manifest indicating amount of tissue blocks and slides from primary tumors, normal tissue and metastatic tissue from the same subjects and a copy of the corresponding pathology reports from the same subjects. b. An excel file documenting all residential history (where the subjects lived for more than six (6) months during their lifetime) for (400) subjects (cases and/or controls) 2. The Contractor shall communicate the study progress in a monthly written report via email to the NCI Technical Point of Contact. Inspection and Acceptance Requirements: The quarterly reports, containing relevant data items, per above, defined above will be scrutinized and subsequently accepted within fifteen (15) business days of receipt. If no comments or request for revisions are provided within fifteen (15) business days, the deliverables shall be considered acceptable. Payment: Payment shall be made in arrears after receipt and acceptance of each deliverable. Payment authorization requires submission of an invoice per the Invoice & Payment Provision included in the order. Clearances: The study has received approvals from the NCI SSIRB (protocol number 02-C-N035). Contract Type: This will be awarded as a Firm-Fixed Price type contract. Award: Award will be made in the aggregate. These support services are provided by the National and Kapodistrian University of Athens. The NCI has successfully conducted a genome-wide association study (GWAS) of melanoma patients and healthy controls from the Mediterranean countries, including Italy, Spain, Greece and Cyprus. The NCI is now investigating the progression of the tumors from the subjects that have already been studied to shed light on the interaction between genetic susceptibility and genome-wide methylation intensity in patients with metastatic melanoma. To conduct this study, The NCI needs to collect tissue blocks from primary tumors, adjacent normal tissue and metastatic lesions from the same Mediterranean patients who also have GWAS data. To extract sufficient DNA from each tissue block, The NCI needs seven (7) sections from each block. Moreover, The NCI needs detailed description of pathology features from each block and a copy of the original pathology report from each subject. The NCI needs residential history for all melanoma cases and controls who were included in the genome-wide association study to link residential history with ambient UVV exposure to conduct a combined analysis of genetics, methylation and UV exposure. The National and Kapodistrian University of Athens, under the direction of Dr. Alex Stratigos, has examined Greek melanoma patients included in the NCI-led GWAS of melanoma in Mediterranean countries. The National and Kapodistrian University of Athens has access to the archived tissue material from these patients with melanoma. No other laboratory has access to these biospecimens. The proposed source has unique access to the melanoma tissue blocks from the Greek melanoma patients who were genotyped at NCI for the GWAS study. Moreover, the National and Kapodistrian University of Athens has access to the IDs of the subjects included in the genome-wide association study and can contact the subjects to collect their residential history. The ITEB's scientific investigation is ongoing, and the performance characteristics and quality of the needed services are required for maintaining the integrity of the stated investigation. A change would be disruptive to the ability to analyze ITEB's cumulative results. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:00PM EDT, on Aug. 24, 2017. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.nih.gov. 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. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02CP72651-76 on all correspondence.
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- SN04627237-W 20170816/170814231811-37006ee4a9193ecff77186b7fa923654 (fbodaily.com)
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