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 092498 POC Patricia Haun, (301) 402-4509 RFQ-NCI-80226-NS for "Type Specific HPV DNA Testing", which was issued as a combined synopsis/solicitation in the printed Commerce Business Daily on September 4, 1998, is amended to provide answers to questions raised by prospective offerors. As a result of the questions, the due date for offers has been extended to September 24, 1998 at 3:00 p.m. EST. The following questions were submitted to NCI, and the answer immediately follows each question: 1. How can we demonstrate the required experience and competency with the Roche HPV PCR test strips when the strips have not been approved by FDA and when the Roche Group in Alameda, California, does not respond to our questions regarding test strip availability? Answer: NCI recognizes that FDA has not approved the Roche test strip for clinical use, and that this may effectively reduce the potentially qualified sources to the approximately six laboratories that have been involved with Roche in validating the test strips. While the test strips have not yet been approved by FDA, they may be used for research purposes, and study information available to NCI suggests that the strips are superior to previous testing methods in several respects. Therefore, NCI elected to use these strips for the subject testing. Experience with the Roche strips is being required because of the large scale nature of the testing and importance of obtaining accurate results. 2. Have the specimens already been collected in DiGene transport media? If no, we have a better collection and transport device which we have shown the ability to amplify. Answer: The specimens have already been collected in DiGene transport media, so no alternatives can be considered. 3. Will the contractor be paid for all PCR tests performed, even when a globin gene cannot be amplified because the specimen in DiGene transport media is refractory to PCR? Answer: NCI will pay for any specimen with negative beta-globin amplification since lack of beta-globin would indicate a problem with the specimen furnished to the contractor rather than a problem with the testing technique used. 4. May the contractor have access to the cervical intraepithelial neoplasia (CIN) status of the specimens, either before or after test results are submitted to NCI? Answer: CIN status information will not be made available to the testing laboratory to protect the blind nature of the testing. 5. While no questions have been received on the requirement, NCI is taking this opportunity to clarify that the contractor will be required to store the specimens to be tested at minus 70 degrees C. This requirement is being clarified because the CBD font conversion makes the temperature requirement potentially unclear in the original synopsis/solicitation. Posted 09/14/98 (W-SN249129). (0257)

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