SOLICITATION NOTICE
B -- Review diagnosis, microdissect and extract DNA from Mediterranean populations.
- Notice Date
- 3/7/2017
- 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
- N02CP72514-61
- Archive Date
- 3/22/2017
- Point of Contact
- KATHY D. ELLIOTT, Phone: 240-276-5570, Lee J. Oliver, Phone: 2402766527
- E-Mail Address
-
ELLIOTTK@MAIL.NIH.GOV, lee.oliver@nih.gov
(ELLIOTTK@MAIL.NIH.GOV, lee.oliver@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E224, Rockville, MD 20850, UNITED STATES Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) plans to procure on a sole source basis services to Review diagnosis, microdissect and extract DNA from Mediterranean populations from Instituto Oncologico Veneto - IRCCS, U.O.C. Immunologia e Diagnostica, Molecolare Oncologica, Care of Dr. Chiara Menin, via Gattamelata, 64 35128 Padova, Italy. 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)(2), 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 $15.0M. 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 shall be twelve (12) months from its award date. It has been determined there are no opportunities to acquire green products or services for this procurement. The Division of Cancer Epidemiology and Genetics (DCEG) is an intramural research program of the National Institutes of Health (NIH), National Cancer Institute (NCI), that conducts population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The purpose of this procurement is to review areas of tumor, adjacent normal and nevus remnant for macro/microdissection and extract DNA from melanoma and other skin lesions collected at The NCI from Mediterranean populations within a one-year period. The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to discover the genetic and environmental determinants of cancer etiology and progression. The tumor microenvironment plays a crucial role in cancer development and thus it is a very important DCEG research objective, particularly within epidemiological investigations. DCEG has invested large resources to characterize the genomic landscape of kidney tumors and needs to examine the relationship between tumor mutation profile and immune infiltrate in the tumor microenvironment. for lung cancer and to provide additional evidence that diesel exhaust causes bladder cancer. Melanoma is one of the most common cancers in Western countries, representing an increasingly important public health problem. Early diagnosis and surgical resection of early-stage primary cutaneous melanoma is usually curative for patients with localized disease, but the prognosis is less favorable for patients with regional or distant metastases. Hot-spot mutations in the V600 codon of BRAF (35-50% of melanomas) and Q61 codons (less frequently, the G12 or G13 codon) of NRAS (10-25%) led to the development of highly selective kinase inhibitors that target the MAPK pathway. Although antitumor responses to those compounds given as single agents and, more recently, in combination have been dramatic, they have rarely been durable. Novel immunotherapies, including monoclonal antibodies directed against inhibitory immune checkpoint proteins such as CTLA-4, PD-1, and PD-L1, have recently shown clinical efficacy for patients with unresectable disease and/or distant metastases. Despite such exciting developments, however, biomarkers for prediction of response to melanoma immunotherapy remain elusive. Clearly additional targets and/or combinatorial treatment strategies are needed and a more precise classification of melanoma tumors could be crucial for the success of these treatment strategies. The 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, photographs of the skin lesions and tissue blocks and tissue slides from melanoma lesions, nevi and metastases. The NCI plans to conduct molecular analyses, including also next generation sequencing, of the collected lesions to provide a more accurate classification of melanoma lesions and the molecular signatures associated with progression. The NCI now needs a molecular oncology laboratory, working closely with the pathologists at the University of Florence, to macro/microdissect the areas identified by the pathologists and extract DNA from tumor, normal and nevus components. The extracted material has to undergo rigorous quality control according to the NCI standard and requires amplification testing to verify the adequacy of the DNA for next generation sequencing analysis. The Contractor shall perform the following tasks: 1. Meet with 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 (15 meetings). The meeting will last 2-3 hours and will involve only Dr. Chiara Menin and Dr. Daniela Massi. 2. Develop 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. 3. Acquire reagents, macro/microdissection, DNA extraction, DNA quality control, replication in case of need, DNA amplification and sample shipment for 1500 tissue specimens to NCI Frederick. 4. Provide a monthly report on the progress of the activities to the NCI Technical Point of Contact via email on NCI prepared excel sheet. 5. The expectation/goal is to extract 2 vials of 4ug each of quality DNA from each subject. The first vial of DNA is to be sent to NCI 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. 6. Return remaining tissue material and stained slides from each lesion examined to the NCI Frederick. It is expected that the laboratory will exercise the above listed requirements for 375 specimens every four months for a total of 1500 samples. Government Responsibilities: At the time of the award, The NCI technical point of contact will coordinate delivery of the material to be evaluated, for dissection, DNA extraction and quality control procedures. The NCI will send the protocol to be followed for the DNA extraction. Reporting Requirements and Deliverables: 1. Every four months the contractor shall provide the following material via email corresponding to 375 specimens to the NCI Technical Point of Contact: a. 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. 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 in section F 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. Clearances: The study has received approvals from the NCI SSIRB (protocol number 02-C-N035). This notice is not a request for competitive quotation. However, if any responsible source, especially small business 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 NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 5:00 PM EST, on March 22, 2017. All responses and questions must be submitted via email to Kathy Elliott, Contracting Specialist at Elliottk@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: N02CP72514-61 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP72514-61/listing.html)
- Place of Performance
- Address: 9609 Medical Center Drive, Rockville, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04426010-W 20170309/170307234918-a7da54031f404a221f4b252208e15d86 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |