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

A -- TYPE-SPECIFIC HPV DNA TESTING SOL RFQ80226-NS DUE 092198 POC Patricia Haun (301) 402-4509 The National Cancer Institute (NCI) plans to procure tests for type-specific HPV DNA on 6,000 cervical specimens 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 8733 and the business size standard is $5.0 million. However, this requirement is not set-aside for small businesses. A. Background The NCI Division of Cancer Epidemiology and Genetics is currently conducting a randomized clinical trial of women diagnosed with cytologically confirmed low-grade squamous intraepithelial lesions of the cervix and atypical squamous cells of unknown significance to determine optimal management of women with these lesions. As part of this study, about 6,000 cervical specimens will be collected from study participants for type-specific human papillomavirus (HPV) DNA testing using highly sensitive PCR methods. The cervical specimens will be collected using a dacron swab and stored in Standard Transport Medium (STM; Digene Corporation). The Government will be responsible for appropriately batching and shipping up to 6,000 specimens to the testing contractor over a period of 12 months. Up to 5% of the 6,000 specimens will be blind duplicate specimens. Testing will be performed with the HPV DNA strip test recently developed at Roche Molecular Systems of Alameda, CA., and the Government will provide the testing contractor with the testing strips, master mix, primers, and strip detection reagents. B. Requirements The purpose of this procurement is to obtain tests for type-specific HPV DNA on 6,000 cervical specimens stored in STM. The contractor shall be responsible for (1) receiving and storing the specimens furnished by NCI at -700C, (2) testing the specimens using the PCR-based testing strips described above, and (3) reporting the HPV type-specific assay results to the NCI Project Officer once every two months in Excel or another suitable computer format. The HPV type-specific assay results shall be reported to NCI in a semi-quantitative scale. Applicable beta-globin amplification results shall also be reported for each specimen tested, and testing dates and batch numbers shall be reported in a consistent fashion. The computer format and data elements used in reporting must be approved by the NCI Project Officer. The contractor may bill NCI for increments of 600 or more completed assays, at the per assay rate, as the testing is completed and the results are reported to NCI. While NCI plans to ship all 6,000 specimens to the contractor within 12 months following award, the period of performance of this procurement will be 18 months to ensure that the contractor has time to receive, test, and report on all of the specimens. NCI shall retain the right to all data derived from the procurement. C. Experience Offers must demonstrateexperience conducting type-specific HPV DNA testing using the strip test technology developed by Roche Molecular Systems. They must also demonstrate their capability to test up to 6,000 specimens within a period of 18 month using strict quality control procedures in the testing. 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 Patricia Haun on (301) 402-4509 or by fax on (301) 402-4513. E. Evaluation Criteria The technical portion of quotations will receive 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) demonstration that proposed techniques for performing the testing, quality control, logging, and tracking of individual specimens, keying individual results, and reporting results to NCI will satisfy the solicitation requirements; (2) experience and capability of personnel in performing type-specific HPV DNA typing of cervical cells using PCR-based assays including the strip test, and in tracking specimens, documenting reproducibility of results, and recording results for this and/or other types of testing projects; (3) corporate capability and experience in performing large-scale testing projects, with emphasis on type-specific HPV DNA testing using the PCR-based strip test; and (4) adequacy and availability of facilities and equipment to perform the work. The evaluation criteria will be assigned the following relative weights: (1) 40%; (2) 40%; (3) 10%; and (4) 10%. F. Offers Offers must be submitted on an SF-18 that is signed by an authorized epresentative of the offeror and includes a completed "Schedule of Offered Supplies/Services." The offer should include a fixed-price for performing testing and related responsibilities on up to 6,000 specimens. Offers must be accompanied by a completed and signed NCI REPRESENTATIONS, 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 materials must be received in this office by 3:00 pm EST on September 21, 1998. No collect calls will be accepted. Please cite the solicitation number, RFQ 80226, on your offer. Posted 09/02/98 (W-SN245048). (0245)

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