Collection of DNA extracted from metastatic tissue specimens from melanoma patients from a Mediterranean population

Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room1E144, Bethesda, MD 20892 USA Description: The National Cancer Institute (NCI), Division of Cancer and Epidemiology (DCEG) plans to procure on a sole source basis to Instituto Valenciano de Oncologia at 46009 Valencia Spain for the collection of DNA extracted from metastatic tissue specimens from melanoma patients from a Mediterranean population. This acquisition will be processed in accordance with the simplified acquisition procedures as authorized by 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 541990 and the business size standard is $15 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Period of performance: A (1) year base period from the time of award and (1) twelve month option period. NCI has conducted a series of studies to investigate melanoma susceptibility and progression in melanoma-prone families and sporadic cases, as well as studies of the transition from common melanocytic nevi to dysplastic nevi to melanoma in Mediterranean populations. Epidemiological and clinical data have been collected as well as blood samples and photographs of the skin lesions of interest. NCI needs now to expand these studies to include the examination of melanoma metastases from the same patients from whom it has already collected and analyzed blood specimens, primary tissue blocks or slides, and clinical and epidemiological data, and possibly collect melanoma specimens from primary and metastatic tumors from additional melanoma patients in the future. The purpose of this contract is to obtain the collection of DNA extracted from metastatic tissue specimens from the same melanoma patients previously examined at NCI. The contractor shall: 1. Within the first three months from date of award, the contractor shall provide the list of available metastatic samples and their location and related subject IDs to allow NCI to verify the appropriateness of the specimens selected. 2. In the following three months the contractor shall send an electronic detailed database with the tissue sections and clinical information related to the selected patients. 3. In the following three months the contractor shall ship the DNA extracted from the three tissue section/metastatic block from 150 metastatic melanoma patients by express courier in shipping containers designed for transporting. 4. In the final three months the contractor shall ship the DNA extracted from the three tissue section/metastatic block from 150 metastatic melanoma patients by express courier in shipping containers designed for transporting. The contractor shall continue to enroll melanoma patients with metastases and collect primary tumor tissue blocks and correspondent metastatic tissue blocks from approximately 150 patients and extract DNA from both the primary tissue (150) and the metastatic tissue blocks (150) and send DNA from the blocks, plus clinical and epidemiological data from these subjects to the NCI COR. The contractor shall communicate the study progress with a monthly written report via email to the COR. Government Responsibilities: At the time of the award, NCI will provide the contractor with a study protocol specifying the necessary study design and procedures for the collection of biospecimens and DNA extraction. NCI has successfully conducted a study of familial melanoma and a study of sporadic melanoma in the Mediterranean populations of Italy and Spain and have identified a susceptibility gene for melanoma (POT1) and additional exposures and gene interactions in the etiology of melanoma. NCI now needs to expand the study to investigate the progression of the tumors from the subjects that have already been studied to shed light on the interaction between exposure, genetic susceptibility and somatic alterations. NCI needs to conduct the study in a center where many melanoma cases have already been diagnosed and related epidemiological and clinical data as well as blood and tissue specimens have already been collected and studied at NCI. The Instituto Valenciano de Oncologia has constituted a melanoma group in the Comunidad Valenciana that includes physicians from the nine largest hospitals of the area, which are served by a large Biobank which aims to collect biospecimens and data from population-based controls for genetic epidemiology studies. The Biobank has estimated that could recruit approximately 500 specimens per year and has already collected over one thousand specimens. The staff at The Instituto Valenciano de Oncologia has been trained in the recognition of dysplastic nevi and melanoma and can ensure continuity and comparability with the research that NCI began years ago in Italy. In addition, the proposed staff has acquired expertise in the practical aspects involved in the management of data, photographs, clinical forms, informed consents, and biospecimens, according to NCI standards and needs, since he has previously collaborated with NCI for a study of sporadic melanoma. The only know contractor to NCI to perform the required tasks is The Instituto Valenciano de Oncolog'a, in Valencia, Spain. This is not a solicitation for competitive quotations. However, if any interested party, especially a small business, believes they can meet the above requirement, they may submit a statement of capabilities and or quote. 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. A copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on September 5, 2014. Electronic capability statements will be accepted (i.e. email or fax). All questions must be in writing and can be faxed to (240) -276-5401 or emailed to Tiffany Kittrell, Contract Specialist, at Tiffany.kittrell@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 System for Award Management (SAM) www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP42621-62 on all correspondence.