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

A -- MEASUREMENT OF TA REPEATS AND V89L POLYMORPHISMS IN THE 5-A REDUCTAGE GENE BY PCR METHOD SOL RFQ-NCI-80227-NV DUE 092498 POC Debbie Moore, Purchasing Agent, 301-402-4509, Todd Cole, Contracting Officer 301-402-4509 COMBINED SYNOPSIS/SOLICITATION FOR SERVICES INVOLVING THE MEASUREMENT OF TA REPEATS AND V89L POLYMORPHISMS IN THE 5-A REDUCTAGE GENE BY PCR METHOD The National Cancer Institute (NCI) plans to procure the subject assay services from the Frederick Hutchinson Cancer Research Center, Seattle, Washington, 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 97-05. The Standard Industrial Classification Code is 8999. However, the proposed contractor is a non-profit organization and this requirement is not set-aside for small businesses. A. Background The NCI Division of Cancer Epidemiology and Genetics plans to procure the subject assay tests as part of a study to investigate reasons for the extremely low risk of prostate cancer in China. 5-a reductase is the enzymethat converts testosterone to dihydrotestosterone in the prostrate gland. Since the activity of 5-a reductase cannot be measured directly, the study will investigate the polymorphism of 5-a reductase in relation to prostate cancer risk. The assays will be performed on samples from 728 male Chinese study subjects. The samples are currently being stored in vials, at -70 degrees C, in a repository at Frederick, Maryland. NCI will ship the samples to the contractor in two shipments following contract award. B. Requirements The purpose of this procurement is to measure the dinucleotide thymine adenine (TA) repeats and V89L polymorphisms in the gene SRD5A2, encoding for enzyme 5-a reductase by the polymerase chain reaction (PCR) method. 1. The contractor shall be responsible for (1) preparing the 728 DNA samples furnished by NCI for assay, (2) amplifying the DNA using the SRD5A2 forward and reverse primers published by Davis and Russel in 44 PCR cycles, (3) using internal standard sequenced clones that containeither TA (0) or TA (9) SRD5A2 polymerase chain reaction products to determine the size of TA repeats in the study, (4) counting TA repeats on the gel for each individual, (5) ensuring that the gel provides resolution to visualize 1 bp differences (as in sequencing), (6) recording and double-keying in the data, (7) storing data in computer-readable format, (8) delivering data to NCI in a timely fashion, (9) providing NCI investigators with details on the PCR procedures and information on quality control, (10) sequencing samples that contain greater than nine TA repeats to determine the true number of repeats, and (11) assisting in the preparation of related presentations and manuscripts. 2. The contractor shall use allelic specific assay to genotype the G to C transversion at condon 89 of the SRD5A2 gene to avoid the potential ambiguities involved with assaying samples with simple strand conformation polymorphism. 3. The contractor must perform the TA repeats and V89L assays at the same time, with a minimum amount of DNA (about 200 ng), to minimize freezing, thawing, handling and potential contamination of the DNA samples. 4.. The contractor shall report results on the genotyping as number of TA repeats or G to C transversion at condon 89. The results shall be transmitted to the NCI Project Officer in Excel or another format approved by that official once every two months. The reporting deliverables shall include all assay results for the SRD5A2 polymorphisms listed above. Quality control data shall be included. 5. The contractor shall store samples at -70 degrees C upon receipt. Permission must be obtained from the NCI Project Officer to use more than 200 ng of DNA from a sample, and the unused portion of samples must be returned to that official. 6. The contractor may bill NCI for increments of 100 or more samples, at the per sample rate, as the work is completed. 7. NCI shall retain the right to all data derived from this procurement. C. Proposed Source The Frederick Hutchinson Cancer Research Center is the only organization known to NCI that can meet the above requirements. In particular, Frederick Hutchinson Cancer Research Center has the only laboratory to NCI's knowledge that can perform assays on both TA repeats and V89L at the same time, with a minimal amount of DNA (approximately 200ng). This ability minimizes the number of freezing and thawing of the DNA sample thus reducing contamination. The Frederick Hutchinson Cancer Research Center is also the only laboratory to our knowledge that has cloned and sequenced the TA repeats to be used as the internal standard. Finally, it is the only known laboratory that will perform DNA sequencing if the number of TA repeats are higher than 18 to ensure the quality of data. The organization performing the requirements must document its ability to reproducibly measure the subject polymorphisms in a blinded fashion and in a methodological study of over 20 subjects. This is not a solicitation for competitive proposals. However, if any other interested party believesthat it can meet NCI's needs, it may submit an offer to Debbie Moore at the address cited above. Your offer must meet all requirements specified herein, including the capabilities identified in the above paragraph. D. Provisions and Clauses The 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 Debbie Moore on (301) 402-4509 or by fax on (301) 402-4513. D. Offers Offers must be submitted on an SF-18 that is signed by an authorized representative of the offeror and includes a completed "Schedule of Offered Supplies/Services." The offer price must include all materials, reagents, labor, facilities, and indirect costs. Offers must be accompanied by a completed and signed NCI REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OFOFFERORS OR QUOTERS (SIMPLIFIED ACQUISITIONS). Offers must also be accompanied by materials demonstrating that the offer and offeror meet the foregoing requirements. Offers and related materials must be received in this office by 3:00 pm EST on September 24, 1998. No collect calls will be accepted. Please cite the solicitation number, RFQ-NCI-80222-NV, on your offer. Posted 09/03/98 (W-SN245230). (0246)

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