Title: Use of cytology material from FNAC smears and cell blocks to validate ER/PR/HER2 and p53 status of breast cancers in Kenya Document Type: Pre-solicitation notice Solicitation Number: N02CP42526-62 Proposed Posted Date: May 9, 2014 Proposed Response Date: May 23 11:00AM EST Classification Code: B529 NAICS Code: 541380 Small Business Size Standard: 500 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), Center for Cancer Research plans to procure on a sole source basis to Aga Khan University at 3rd Parklands Avenue Nairobi, 00100, Kenya for Use of cytology material from FNAC smears and cell blocks to validate ER/PR/HER2 and p53 status of breast cancers in Kenya. 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 will be 12 months from award. The Center for Global Health supports NCI's goal to advance global cancer research, build expertise, and leverage resources across nations to address the challenges of cancer and reduce cancer deaths worldwide. One of the primary functions of the Center is to develop and validate new methods for cancer prevention, screening, diagnosis, and treatment appropriate for use in the developing world. Breast cancer is the most common cancer in Kenya. Primary diagnosis is usually made by fine needle aspiration (FNA) cytology, but this precludes hormone receptor analysis by current methodology, which requires tissue sections with adequate tumor for receptor analysis by immunohistochemistry (IHC). Core biopsy technique, which would provide ample tissue for IHC and determination of tumor markers, is available in only 3-4 centers in the entire country. As a result, most women in Kenya receive empiric, sub-optimal treatment for their breast cancer, based only on clinical features such as age, menopausal status, and extent of local disease, without appropriate hormonal therapy based on their tumor's ER, PR and Her2 status. One option for improving breast cancer care in Kenya (and other countries in Africa) would be to introduce the core biopsy technique at the local hospital level, but this is currently not possible due to the expense of the equipment (core biopsy guns and single use core biopsy needles) and the lack of training in the use of the biopsy gun technique. Another option would be to develop new methodology that would allow accurate hormone receptor analysis on FNAC material. Successful development of such methodology would represent a huge step in providing adequate breast cancer care in Kenya and elsewhere in the developing world. This acquisition requires the contractor to perform both FNA and core biopsy sampling of malignant breast masses from 50 patients in Nairobi, Kenya. In addition to routine diagnostic smears, additional air-dried smears and a cell block sample must be prepared from the FNA sample. For each case, the additional air-dried smears, sections of the cell block sample, and sections of the core biopsy must be stained by IHC for estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (Her2), and p53 protein. The IHC-stained smears and sections must then be scored as positive or negative for each stain by experienced pathologists according to standard criteria. Aga Khan University Hospital Nairobi (AKUHN) is the only known tertiary level hospital in Nairobi, Kenya with a dedicated Breast Clinic, abundant experience performing both FNA and core biopsy procedures on palpable breast masses. They have well-established histology and cytology diagnostic pathology capabilities, and a functional and validated IHC platform for breast hormone receptor testing. Thus, AKUHN is the only source that can provide the data required for this procurement. 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. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on May 23, 2014. Electronic capability statements will be accepted (i.e. email or fax). An original and one copy must be sent to the NCI Office of Acquisitions at the address stated above. All questions must be in writing and can be faxed to (240) -276-5401 or emailed to Tiffany Kittrell, Contract Specialist, at
contact@example.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 N02CP42526-62 on all correspondence.
