SOLICITATION NOTICE
Q -- Review diagnosis, microdissect and extract DNA from Mediterranean populations.
- Notice Date
- 8/6/2015
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- N02CO52679-78
- Archive Date
- 9/5/2015
- Point of Contact
- Francisco Mendoza, Phone: 2402765668
- E-Mail Address
-
francisco.mendoza@nih.gov
(francisco.mendoza@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Short Title: Review diagnosis, microdissect and extract DNA from Mediterranean populations. Document Type: Presolicitation Notice Solicitation Number: N02CO52679-78 Posted Date: 8/06/2015 Response Date: 8/21/2015 8:00 AM EDT Classification Code: Q301 NAICS Code: 541990 Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E140, Rockville, MD 20850, UNITED STATES Description National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Genetic Epidemiology Branch (GEB) plans to procure on a sole source basis, services to review diagnosis, microdissect and extract DNA from Mediterranean populations, from the Istituto Oncologico Veneto, Via Gattamelata, 64, Padova Italy 35128. 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 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. The period of performance is twelve (12) months from date of award for the Base Year, and one additional Option Year. It has been determined there are no opportunities to acquire green products or services for this procurement. Project Objectives: The purpose of this procurement is to fund a premier molecular oncology laboratory to macro/microdissect the tumor, nevi, metastases and normal adjacent areas previously identified by experienced pathologists, and extract, quantify, review the quality and ship the DNA extracted from the macro/microdissected sections together with an electronic database linking all lesions with the original melanoma diagnosis. This work will include 1500 samples from multiple lesions. If the works proves successful, NCI could continue the procurement to an additional option year to extend the same work for additional 1500 tissue specimens. 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 is now investigating 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. To conduct these studies, NCI is working with an experienced group of pathologists at the University of Florence, Italy who review all skin lesion diagnosis collected from each center and identify areas of tumor, adjacent normal tissue and the presence of nevus remnants, and prepare a correspondent database with clinical data and scanned images of the reviewed lesions. The dermatopathologists at the University of Florence works closely with the molecular oncology laboratory at the Istituto Oncologico Veneto, Padua, Italy and have developed combined protocols and approaches for reviewing the lesions to facilitate the correct dissection and DNA extraction. The two laboratories have been working in the Mela Nostrum Consortium coordinated by NCI and have provided NCI with a series of previous reports and pilot studies. NCI needs to conduct the future procedures in melanoma samples from Mediterranean populations following the same protocols, and using the same classification developed by the two collaborating laboratories. Consequently, NCI has identified the U.O.C. Immunologia e Diagnostica Molecolare Oncologica (Immunology and Molecular Oncology Unit), Istituto Oncologico Veneto as the source capable of providing all the deliverables requested. Any other laboratory would involve retesting all procedures, beginning a new collaboration with the pathology Department in Florence and conducting a series of new pilot investigations to define the best Standard Operating Procedures with considerable delay and cost for NCI. Thus, the laboratory of the Istituto Oncologivo Veneto of Padua is the NCI choice for this contract. Contractor Requirements: The Contractor shall: The Contractor shall, for all contract periods: Have a meeting between pathologists and molecular biologists to review the lesions and to identify the extraction area and the appropriate technique for the extraction. The meeting will be held in the University of Florence, to review approximately 100 samples each time (for a total of 15 meetings). Development of a protocol for the optimal sample processing and extraction, which will depend on the material used for tissue block fixation, the depth of the lesions, the presence of normal adjacent material and/or presence of nevus remnant, and database tracking of all lesions, extracted materials and shipments using pre-barcoded labels Conduct the acquisition of reagents, macro/microdissection, DNA extraction, DNA quality control, replication in case of need, DNA amplification and sample shipment for 1500 tissue specimens. It is expected that the laboratory will exercise the above listed requirements for 375 specimens every four months. The contractor shall provide a monthly report of study activities to the NCI Contracting Officer's Technical Representative (COR). Government Responsibilities At the time of the award for each contract period, NCI will coordinate delivery of the material to be evaluated, for dissection, DNA extraction and quality control procedures. NCI will define and report the procedures/kits for DNA extraction. Reporting Requirements and Deliverables For the Base Year and the Option Year (if applicable), every four months the contractor shall send the following material corresponding to 375 specimens to the NCI COR: An electronic manifest indicating amount of extracted DNA from tumor, normal adjacent tissue and nevus remnant; any depleted slides; successful/unsuccessful DNA extraction or other issues; Sample IDs of the DNA extracted per subject. Extract 2 vials of 4ug each of quality DNA from each subject. The first vial of DNA is to be sent to NCI at no additional cost to the Government to be added to the consortium inventory for molecular studies. The second vial, if obtained, is to be transferred to the University of L'Aquila for targeted sequencing. If the lesions are too small to obtain a second vial, the contractor should alert the NCI Project Officer, who will decide whether to split the first vial between NCI and the University of L'Aquila or send everything to NCI. Funding for the target sequencing will be conducted at no additional cost for the Government. Return to NCI remaining tissue material and stained slides from each lesion examined. The contractor shall communicate the study progress with a monthly written report via email to the COR. Inspection and Acceptance Requirements All data material, databases, and biospecimens will be reviewed and approved by the NCI COR within 15 days from receipt. Payment The contractor will be paid after acceptance of each deliverable. A submission of an invoice as per the Invoice and Payment Provisions is required. Clearances The study has received approvals from the NCI SSIRB (protocol number 02-C-N035). Contracting Officer's Representative (COR) To be determined before the award of the contract. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 7 AM EDT, on August 21, 2015. All responses and questions must be via email to Francisco Mendoza, Contracting Specialist at francisco.mendoza@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. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: N02CO52679-78 on all correspondence.
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