Review diagnosis, microdissect and extract DNA from melanoma and other skin lesions collected at NCI from Mediterranean populations

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 Universita Degli Studi Di Firenze at Largo Brambilla, 3 50134 Florence, Italy for the review diagnosis, microdissect and extract DNA from melanoma and other skin lesions collected at NCI from Mediterranean populations. 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, photographs of the skin lesions and tissue blocks and tissue slides from melanoma lesions, nevi and metastases. 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. NCI needs to verify the diagnosis of the lesions, microdissect the tumor area and the adjacent - normal area and DNA from the microdissected sections of ~ 3,000 tissue specimens. Specimens include tissue materials collected at different phases of development, e.g., nevi, dysplastic nevi, in situ melanoma, RDP melanoma, VGP melanoma, and metastases in lymph nodes, skin and distant organs. The purpose of this procurement is to collaborate with a dermatopathology laboratory to confirm diagnoses of melanoma, nevi, and metastases from 1500 tissue specimens, microdissect the tumor, nevi, metastases and normal adjacent areas, and extract, quantify and ship the DNA extracted from the microdissected sections together with an electronic database with clinical data and scanned imaging of the reviewed lesions. The contractor shall: 1. Review of histological diagnosis of nevi, dysplastic nevi, other nevi types, melanoma lesions with specific subtypes and metastases from tissue specimens collected at NCI from different studies of Mediterranean populations 2. Microdissect tumor and adjacent - normal tissue areas from 1 to 20 tissue blocks and tissue slides/patient. If the size of the lesions allows, three 20-micron sections from each tissue blocks is expected. 3. Return to the NCI COR the remaining specimens and the stained slides used for the diagnosis using an appropriate express courier 4. Extract DNA from the microdissected lesions, quantify it and aliquot it in a single vial for each material type (tumor, nevi, metastasis, normal adjacent tissue, etc.) and ship the correspondent samples to the NCI COR in dry ice with a dedicated courier. 5. Prepare an electronic database reporting the diagnosis, the histological characteristics, the number of specimens returned to NCI and the quality and quantity of the extracted DNA. 6. Scan in jp2 format all reviewed lesions and put them online for web access using a telepathology service. These requirements are for 1500 tissue specimens. It is expected that the laboratory will exercise the above listed requirements for 500 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, NCI will provide the contractor with all the specimens that require diagnosis, microdissection and DNA extraction from melanoma patients. The Dermatopathology Unit at the Department of Surgery and Translational Medicine (DCMT), University of Florence, Florence, Italy, is a renowned center for the diagnosis of melanoma and non-melanoma skin cancer. This center has a long-lasting specific experience in the pathology of melanoma, provides second opinions and subspecialty consultations that are the basis for an effective patient care. The breadth of activity within the Division of Pathology encompasses adjunctive techniques including immunohistochemistry, in situ hybridization (ISH), fluorescence in situ hybridization (FISH) and molecular analyses. The Unit annual work flow includes 40,200 cyto-histopathological analyses, 45,000 immunohistochemical analyses, 520 ISH, 1500 FISH analyses, and 800 molecular analyses for personalized therapies. The proposed staff at University of Florence is well acquainted with the practical aspects involved in the management of data, photographs, clinical forms, informed consents, and biospecimens, according to NCI standards and needs. At the same time, being located in Italy, staff within the University of Florence is also experienced with the materials collected, fixed in paraffin and stored according to the Italian standards, and therefore, qualified to work with the specimens collected by NCI in Mediterranean populations. The University of Florence, Italy is the only known contractor to NCI that can perform the required tasks. 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 N02CP42620-62 on all correspondence.