DIRECTOR, USAMRAA, 820 CHANDLER ST, FORT DETRICK MD 21702-5014

66 -- SEQUENCE ANALYSIS SYSTEM SOL DAMD17-98-Q-0003 DUE 011298 POC Contract Specialist Sherry D. Regalado (301) 619-2376 Contracting Officer George J. Bauman, Jr. (301) 619-2369 (Site Code DAMD17) The U.S. Army Medical Research Acquisition Activity has a requirement for a additional instrumentation that will double the capacity of existing equipment for providing drug resistance data to physicians. The current instrumentation being utilized is a GeneChip Sequence Analysis System. The Army intends to negotiate with Affymetrix Inc., 1145 Sonora Court, Sunnyvale, CA 94086 as the only one responsible source. This notice is not a request for competitive proposals. See Note 22. This requirement is a combined sole source synopsis/solicitation for Commercial Items (CI) prepared in accordance with the format in the Federal Acquisition Regulation (FAR 12.6, as supplemented with additional information included in this notice). This announcement constitutes the only solicitation and a written solicitation will not be issued. The Government contemplates a firm fixed price award. A response from Affymetrix is being requested and a written solicitation will not be issued. Affymetrix shall satisfy this requirement by providing the following items: One (1) each Genechip Sequence Analysis System, Part No. 900135; two (2) each Genechip Fluidics Station 400, Part No. 800101; one (1) each Genechip Sequence Analysis Workstation, Part No. 800113. The foLlowing Salient Characteristics and features representative of the Government's needs shall be met. The Genechip Sequence Analysis System shall: A. Employ GeneChip probe array that combines solid phase chemical synthesis with photolithographic fabrication techniques; B. Shall have the capability of scanning high density arrays of the HIV-1 virus sequences which can be assessed simultaneously through automated con-focal argon laser interrogation; C. Image processing software shall be capable of processing information from the high density arrays within 30 minutes; D. Shall use a liquid based, hybridization technology in a fully automated fluidics station; E. GeneChip software shall be capable of interactively gathering experimental information from the operator via dialog boxes; F. GeneChip software shall be capable of generating real time image of fluorescence intensity information from the probe array and storing it in a raw data file; G. The technology shall be amenable to deployment in the Government laboratory facility and of sufficient flexibility as to be utilized by Government scientists on site. The Goverment will not accept a service arrangement for the implementation of high density DNA genomic analysis. H. The protocols developed and validated by Government laboratories are unique to the Affymetrix system and are the intellectual property of the Government. Over 100 clinical samples from HIV-1 infected military health care beneficiaries have been studied thus far. A clinical protocol, cleared by scientific review and human use Tri-Service approval is in place which specifies the use of the Affymetrix platform for the assessment of anti-viral drug therapy for HIV-1 infected persons; therefore, the supplied system shall produce the exact results under the existing clinical protocol in the existing on-going study; I. Since the Government has already expended a large amount of time and expense perfecting the application of the Affymetrix technology with existing instrumentation, the new equipment shall allow for the expansion of the throughput of the operation and be totally compatible with the existing platform so as not to corrupt existing data under the protocol in use; J. The technology provided shall allow for a parallel manufacturing process that enhances data reproducibility and be unmatched in achieving economy of time and scale; K. The technology provided shall allow for identification of single base pair mutations that indicate resistance to anti-viral drugs. L. Technology provided shall have the capability of wide scanning capability for interpreting the data from a high resolution chip and speed up the process of single base mutation analysis 100 fold over acrylamide based sequence systems; M. The fluidics station shall automate the hybridization process, contolling and standardizing time, temperature and stringency of wash steps to assure sample to sample consistency; N. A single workstation shall be available for use by several scientists and technical staff with a minimum of training; O. Real time assessment of a data collection event is required to allow the operator to evaluate directly, the quality of the data being generated from the clinical specimen and to abort poor runs. Any interested offeror may identify their interest and capability to meet the Government requirement by submitting a capability statement with must contain sufficient information and detail for the Government personnel to determine if the type of products proposed meets the Government's needs based upon the characteristics described herein. All capability statements must be received by 12 January 1998 close of business 4:00 PM local time. Warranty shall be for a period of one year. Delivery shall be FOB Destination within 150 days after receipt of order. This solicitation incorporates the provisions at FAR 52.212-1, INSTRUCTIONS TO OFFEROR-COMMERCIAL ITEMS and at FAR 52.212-3, OFFEROR REPRESENTATIONS & CERTIFICATIONS-COMMERCIAL ITEMS. The latter provision includes the DUNS NUMBER ADDENDUM. The resulting order will incorporate the requirements of the clause at FAR 52.212-4, CONTRACT TERMS & CONDITIONS -- COMMERCIAL ITEMS & the requirements contained in paragraphs (a) & (d) of the clause at FAR 52.212-5, CONTRACT TERMS & CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS COMMERCIAL ITEMS -- DEVIATION FOR SIMPLIFIED ACQUISITIONS. The contract will also incorporate certain clauses cited in paragraphs (b) & (c) of the clause at FAR 52.212-5. All capability statements submitted must include a completed copy of FAR 52.212-3, OFFEROR REPRESENTATIONS & CERTIFICATIONS -- COMMERCIAL ITEMS with their offer. These representations and certifications must be signed by an authorized representative of the offeror. Full text copies of these representations & certifications or other cited provisions and clauses may be obtained from Sherry Regalado, (301) 619-2376 or by fax on (301) 619-3002. Please cite the solicitation number on your proposal. See Note 22. (0359)

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