The National Cancer Institute (NCI) Clinical Genetics Branch (CGB) Community Oncology and Prevention Trials Research Group (COPTRG) plans to procure on a sole source basis, Clinical BRCA1 and BRCA2 Germline Mutation Testing with Myriad Genetics Laboratories, Inc., 320 Wakara Way, Salt Lake City, UT 84108-9930. The supplies and services herein are commercial as defined in FAR Part 12, and this acquisition is being made in accordance with the test program for using simplified procedures for certain commercial items as authorized in FAR Part 13.5. The North American Industry Classification System Code is 541720 the business size standard is $7.0M employees. The contractor shall provide CLIA-certified germline mutation testing for the BRCA1 and BRCA2 breast/ovarian cancer susceptibility genes. This clinical testing will be provided to a subset of women who have previously enrolled in the National Ovarian Cancer Prevention and Early Detection Study, also known as Gynecologic Oncology Group protocol 199 (“GOG-199”). This study is now closed to new patient enrollment; 5 years’ prospective follow-up is underway, and will be complete in November 2011. The contractor will provide clinically-based germline mutation testing of BRCA1 and BRCA2 in a manner that is consistent with current clinical practice standards for a maximum of 1,405 participants: The period of performance is for one year with two one-year options and one 5-month option. This contract will be awarded as an indefinite delivery indefinite quantity (IDIQ) contract with established minimum and maximum quantities. Myriad Genetics owns the patents on both the BRCA1 and the BRCA2 genes, and is the only known source to the NCI available to perform the required work. The assay procedure employed to identify germline mutations in the BRCA1/2 genes is difficult and complex. It is essential to the ongoing scientific integrity and validity of the research studies being supported to obtain future data in a manner which will permit reliable comparison with assay results already obtained from GOG-199 subjects who have been tested clinically prior to enrollment in the study. Failure to do so could invalidate the cornerstone of these important research projects, i.e., the accurate, timely and reliable classification of study participants with regard to their BRCA1/2 germline mutation status. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, 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 the researcher to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11:00 a.m. ET on January 14, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Malinda Holdcraft: [email protected]. It is the vendor’s responsibility to ensure questions have been received. 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, contractor must have valid, updated registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference NCI-80164-NG-01 on all correspondence.

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