National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

A -- DNA SEQUENCING AND GERMLINE TESTING SOL RFQ-NCI-90175-NR DUE 090799 POC Marsha Gorham, Purchasing Agent, & Todd Cole, Contracting Officer The National Cancer Institute (NCI), Division of Clinical Sciences (DCS), Medicine Branch plans on procuring services for DNA sequencing and germline testing from Myriad Genetics Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108 BACKGROUND: Over 180,000 new cases of breast cancer occur in the United States each year, and approximately 45,000 women will die of this disease annually. Although adjuvant chemotherapy has given us both increases in disease free and overall survival, the prognosis for patients with advance disease is still poor. Although there have been some recent advances in treatment for advanced disease, we realize that the best treatment is still prevention and/or early detection. Individuals with germline mutations in either the BRCA-1 or BRCA-2 (Breast cancer associated genes 1 and 2) are at substantially increased risks of both breast and ovarian cancer. Estimates range from a life time risk of 50-85% for breast and 15-40% for ovarian cancer. It is not yet clearly established if cancers from these individuals should be treated by other than standard treatments, or if somehow these tumors can be prevented in a targeted fashion. Traditionally, education and counseling have been offered on a one to one basis prior to germline testing. Often, hours are spent with an individual. At some centers, multiple visits are standard. Since there is often a shortage of health care workers, this approach is not applicable to most health care delivery systems. NCI began offering education in small groups approximately 18 months ago, using the same informational content commonly used in one-to- one sessions. Based on preliminary, nonrandomized results, there appears to be no difference in learning and general patient satisfaction based on the results of the education pre and post-tests. It is our contention that group education is equivalent, and in some situations better than individual education. Therefore, NCI is conducting a randomized trial designed to test equivalence between individual and group education in individuals that are deciding whether or not to undergo germline testing. The overall purpose of this project is to attempt to establish that group education is as equivalent, if not better than individual education prior to germline testing, and to begin to establish a database which will include clinical information, germline status, demographics, in addition to collection of tissue samples, serum samples, nipple aspirate fluid and genotyping for differences in single allele polymorphisms. Since it has been clearly established that patients, when asked in a hypothetical situation, whether or not they would proceed with testing (after education) do not always respond the same way in a hypothetical setting as they do in a true setting, it is imperative that we actually make available to our patients germline testing once they have been randomized to either group or individual education. BASIC REQUIREMENT: The Contractor shall peform full sequence DNA analysis of BRCA1 and BRCA2 genes for subjects who are enrolled in the NCI protocol. (except for individuals with previously identified mutations in their family, who only require specific or (spot) sequencing.) We require that the turn around time for processing of each designated test (whether BRCA1, BRCA2, or both together, or single mutation testing) be approximately 3-4 weeks. The Contractor shall provide specimen transportation kits and specimen transport. The NCI will utilize the provided kits to provide the Contractor with all specimens to be analyzed. In testing, if a mutation is identified, the precise mutation will be noted with reference to exact sequence and location within the gene. Each report shall include a written clinical summary of the test result. The summary shall state whether a specific genetic variant is identified within each of the two genes, and provide a clinical interpretation and include an assessment of the likely effect of the mutation on the protein encoded by the gene. In total, the Contractor shall performthe following tests (estimated quantities in parentheses): 1) BRCA2 (2 Samples), 2) Sequencing BRCA1 & BRCA 2 (30 Samples), and 3) Sequencing for single spots (18 Samples). Myriad is the only source known to the NCI Researcher that can perform the above gene testing. Myriad Genetics Laboratories is the only CLIA approved institution allowed to perform the necessary BRCA1 and BRCA 2 germline sequencing . Furthermore, Myriad holds a patent on these genes and the required testing for mutations. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement and it is CLIA approved for the above testing, it may submit a statement of capabilities. 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 this requirement. Capability statements must be received in the contracting office by 3:00 p.m. EST, on September 7, 1999. If you have any questions, please contact Marsha Gorham, Purchasing Agent on (301) 402-4509. 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. Posted 08/18/99 (W-SN369436). (0230)

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