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

B -- SPECIAL STUDIES AND ANALYSIS -NOT R&D SOL RFQ-NCI-00071-NQ DUE 032300 POC Cynthia Brown, Purchasing Agent, 301-402-4509, Todd Cole, Contracting Officer  The National Institutes of Health, Medicine Branch (MB), Division of Clinical Sciences(DCS), National Cancer Institute plans to procure commercial gene sequencing services from Veritas,Inc., 679 Southlawn Lane, Rockville, MD 20850. Differences in androgen receptor(trinucleotide) repeat length recently have been linked to prostate cancer risk. In a study of men participating in the Physicians Health Study, a comparison was made between 368 men with prostate cancer and 368 age-matched controls. In this study, men with high grade and/or high stage prostate cancer had a statistically significant higher proportion of short trinucleotide repeats. In addition, initial observations in prostate cancer patients suggested an inverse relationship between trinucleotide repeat length and cancer progression. It is conceivable that current approaches to prostate cancer screening/prevention efforts could be altered if the ability to stratify men according to prostate cancer risk by a simple genomic test isestablished. A current NCI study is evaluating the correlation between the length of the trinucleotide repeat region in the androgen receptor to the development of prostate cancer in a large patient population. The Medicine Branch has a validated method of quantitating the trinucleodide repeat length from frozen serum. However, the amount of specific fragment amplified by PCR (Polymerase Chain Reaction) from the minute (minute is less than 10 ng) amounts of DNA in serum are often not sufficient to carry out the DNA sequencing. No further PCR amplification can often be done since the appearance of possible artifacts generated during PCR are deleterious to the end result. However, Veritas, Inc. has developed a highly efficient assay for the biological amplification of the number of trinucleotide repeats within the subject gene. The assay utilizes the aforementioned, minute amounts of DNA in serum and can biologically amplify the PCR fragment of interest. The assay reproducibly generates results of repeats,and,more than 98% of minute samples yield results under this commercial process. Furthermore, Veritas, Inc. can perform the Medicine Branch's projected 5,000 assays that will need to be done over the next year. Veritas currently has a patent outstanding on this assay. Veritas, can also provide weekly on site consultation and 24 hour telephone hotline service. Due to the rapid degradation of our samples, courier service shall be provided within an hour of calling for sample pickup. Veritas, can provide data analysis and statistical evaluation for all samples using the assay described herein. Veritas, Inc. is the only source known to NCI's researcher who can perform the above assay with such a minute amount of serum and still yield results. This is not a request for quote. However, if any interested party believes it can perform the above work 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 NCI to determine if the party can perform this requirement. The statement shall also include demonstrable evidence of how many minute samples yield results, as well as the size of such samples classified as minute. Capability statements must be received in the contracting office by 1:00 p.m. EST, on March 23, 2000. If you have any questions, please contact Cynthia Brown, Purchasing Agent on (301) 402- 4509. 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. Posted 03/06/00 (W-SN431352). (0066)

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