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

B -- SPECIAL STUIDES AND ANALYSIS-NOT R&D SOL RFQ-NCI-00028 DUE 122799 POC Cynthia Brown, Purchasing Agent, 301-402-4509, Todd Cole, Contracting Officer  The National Cancer Institute, Clinical Genetics Branch (CGB), Division of Cancer Epidemiology and Genetics is engaged in an ongoing clinical genetics study of hereditary breast/ovarian cancer. CGB has a need to obtain complete sequencing of the two breast/ovarian cancer susceptibility genes known as BRCA1 and BRCA2 as part of this project. This requirement will be done in accordance with the simplified acquisition procedures authorized in FAR Part 13. This announcement constitutes a combined synopsis/solicitation, and a separate written solicitation will not be issued. The solicitation includes all applicable provisions and clauses in effect through FAR FAC 97-14. The Standard Industrial Classification Code is 8071 and the business size standard is $5.0 million. However, this requirement is set-aside for small businesses. BACKGROUND: Samples were derived from individuals who are members of families in which these two cancers have occurred with unusual frequency. This study is part of a comprehensive, multidisciplinary, intramural research program within DCEG's Human Genetics Program which is focused upon elucidation of the entire spectrum of scientific and clinical issues related to familial and hereditary forms of cancer. The objective is to gain further insight into the mechanisms and clinical consequences of identifying BRCA1 and BRCA2 mutations in members of families prone to breast and ovarian cancer. The specific objective is to obtain full genetic sequencing of the BRCA1 and BRCA2 genes from DNA samples provided by 80 high-risk family members. REQUIREMENTS: 1) Receive coded DNA samples from CGB investigators for genetic analysis. The Contractor will be blinded to any identifying information pertaining to the individual from whom these specimens were derived and will be prohibited from seeking any such information. The samples will be anonymous. 2) Aliquots of patient DNA shall be subjected to polymerase chain reaction (PCR) amplification (35 reactions for BRCA1; 47 reactions for BRCA2). 3) The amplified products shall each be sequenced in forward and reverse directions using fluorescent dye-labeled sequencing primers. 4)Chromatographic tracings of each amplicon shall be analyzed by means of automated, computer-based review followed by manual/visual inspection and confirmation. 5) Genetic variants shall be detected by comparison with a consensus wild-type sequence constructed for each gene (i.e., BRCA1 and BRCA2). 6. Potential genetic variants shall be independently confirmed by a single replication of the PCR amplification of the indicated gene region(s) and sequence determination as indicated. 7.The CGB Investigators shall be provided with a formal written report in which the complete spectrum of sequence changes identified in each sample is specifically described and the relationship of each variant to cancer susceptibility is specified (i.e., disease-related; neutral polymorphism; variant of uncertain significance) . 8. A written report shall be returned to the CGB Investigator within thirty(30) days of specimen receipt, except in the case of unusual problems requiring additional investigation. These exceptions must be negotiated directly via telephone discussion with the CGB Investigator. In addition, each report shall document the exceptions with a status report. The reports will be subject to acceptance by the NCI Project Officer (CGB Investigator) responsible for this project. The reports shall be evaluated within seven (7) working days of receipt, and any noted deficiencies shall be corrected by the Contractor. A final report shall be submitted within 10 working days if deficiencies were noted; otherwise, the initial report shall be considered final. The Government will arrange for the Contractor to receive the DNA samples which are to be appropriately stored and tested. It is anticipated that the samples will be sent in batches, with the first set to consist of approximately 35 specimens. The size of subsequent batches will be determined by ongoing study results. EXPERIENCE: Offers must demonstrate experience conducting BRCA1/BRCA2 Gene Sequencing. PROVISIONS and CLAUSES: This solicitation incorporates the NCI Representations, Certifications, and Other Statements of Offerors or Quoters (Simplified Acquisitions). The award document will incorporate the requirements of the clause at FAR 52.213-4, Terms and Conditions-Simplified Acquisitions. Full text copies of these documents may be obtained from Cynthia Brown on (301) 402-4509 or online NCI website http://amb.nci.nih.gov/SAP/sap.htm. EVALUATION CRITERIA: The technical portion of quotations will received paramount consideration in selecting a vendor. However, price will also be a significant factor in the event that two or more vendors are determined to be essentially equal following the evaluation of technical factors. In any event, the government reserves the right to make award to the vendor whose offer provides the greatest overall value to the Government. Offers will be evaluated based on the following technical criteria: 1) APPROACH:(35%) The Offeror shall describe the methods used to perform this requirement. The proposed methods and approach shall demonstrate an understanding and awareness of the tasks required in performing full sequencing of the BRCA1 and BRCA2 genes, specimen processing, tracking and data analysis techniques which are practical, sound, and proven. In addition, the approach shall contain aspects that demonstrate an awareness of potential methodological problems. 2)EXPERIENCE AND CAPABILITY OF THE OFFEROR: (35%) The Offeror shall provide evidence of having successfully performed full sequencing of the BRCA1 and BRCA2 genes of similar magnitude. The staff shall have education, knowledge and experience in the areas of BRCA1 and 2 gene structure and nucleic acid sequencing. 3) QUALITY CONTROLS: (20%). The Offeror shall possess Clinical Laboratory Improvement Act (CLIA) certification and demonstrate elements of quality control, including programmatic and administrative safeguards.4) FACILITIES AND EQUIPMENT: (10%) The Offeror shall demonstrate that its facilities and equipment are capable of effectively and efficiently meeting the sequencing, specimen processing, tracking and data analysis needs herein, as well as the throughput requirements. As noted above, the evaluation criterial are assigned the following relative weights: (1) 35%; (2)35%; (3) 20%; and (4) 10%. TECHNICAL INFORMATION FOR THE OFFER: In addition to other required information and items that the offeror believes are relevant in demonstrating capability, responsibility and responsiveness, the Offeror shall ensure its offer/technical quotation includes the following information: 1) The Offeror shall document all previous projects involving BRCA1/BRCA2 Gene Sequencing and summarize the associated work performed; 2) The Offeror shall include a thorough discussion of its approach to completing the requirement, including the framework (including administrative) for maintaining quality control; 3) The offer shall include curriculum vitae or resumes of all technical persons proposed with their education, experience and other qualifications; 4) the Offeror shall describe its facilities and equipment that will be used in performing the requirement. OFFERS: Quotations must be submitted on an SF-18 that is signed by an authorized representative of the vendor and includes a complete "Schedule of Offered Supplies/Services." Offers must be accompanied by a completed and signed REPRESENTATIONS and CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR QUOTERS(SIMPLIFIED ACQUISITIONS). Offers must also be accompanied by a technical proposal that includes materials demonstrating that the Offeror has the capability and experience specified in this announcement. Offers and related material must be received in this office by 2:00 pm EST on 12/27/99. Please cite the solicitation number, RFQ-NCI-00028, on your offer. Posted 12/09/99 (W-SN407277). (0343)

Loren Data Corp. http://www.ld.com (SYN# 0013 19991213\B-0006.SOL)