PRESOL | B | Analyzing Helicobacter Species (H. species) and Biliary Tract Cancer

FBO DAILY ISSUE OF AUGUST 24, 2008 FBO #2463
SOLICITATION NOTICE

B -- Analyzing Helicobacter Species (H. species) and Biliary Tract Cancer

Notice Date: 8/22/2008
Notice Type: Presolicitation
NAICS: 541380 — Testing Laboratories
Contracting Office: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
ZIP Code: 20852
Solicitation Number: NCI-80202-MM
Archive Date: 9/17/2008
Point of Contact: Melissa P Marino,, Phone: 301-402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
E-Mail Address: marinome@mail.nih.gov, cr214i@nih.gov
Small Business Set-Aside: N/A
Description: The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Hormonal and Reproductive Epidemiology Branch (HREB) plans to procure on a sole source basis services in analyzing Helicobacter Species (H. species) and Biliary Tract Cancer with the University of Lund, Clinical Microbiology & Immunology, Division of Bacteriology; This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1 (b)(1). The North American Industry Classification System code is 541380 the business size standard is $11 million. Helicobacter infection is an emerging hypothesis for biliary tract cancer and biliary stones. Molecular studies have shown that DNA of H. species ( H. hepaticus, H. bilis, and H. pullorum ) can be detected in gallbladder and bile duct tumor tissue, suggesting a possible role [for] these bacteria in the etiology of biliary carcinogenesis. However, investigation of the Helicobacter hypothesis, especially that of the H. species, is hampered by the lack of specific assays to detect antibodies to H. species. This is due largely to the potential cross-reactivity in assays of H. pylori and H. species and to a relatively high prevalence of H. pylori infection (>50%) in most populations. The contractor shall provide support for laboratory analysis of H. pylori, H. pullorum, H. bilis, and H. hepaticus in serum samples from the NCI-Shanghai Biliary Study. In the Shanghai Study, the NCI has detected Helicobacter DNA in bile samples and have measured antibodies to H. species. in serum samples of biliary tract cancer cases and controls. The NCI plans to use enzyme-linked immunosorbent assays (ELISA) to measure antibodies to H. species in 595 samples, coming from both cases and controls. The contractor shall:  ·  Measure H. pylori, H. pullorum, H. bilis, and H. hepaticus in 0.3 ml serum sample (up to 595 samples) using enzyme-linked immunosorbent assays (ELISA) with high sensitivity and specificity.  · Store all samples at -70 degrees Centigrade and return the unused serum to NCI. The Period of Performance will be from September 20, 2008 to September 10, 2009 H. hepaticus, H. bilis, and H. pullorum, and H. pylori will be measured using enzyme-linked immunosorbent assays (ELISA). This method was developed by Dr. Wadstrom at the University of Lund. Currently, no other lab is performing these assays. In addition, we have pilot tested assays in this lab and shown that the reproducibility is good. The assays have good sensitivity and specificity. Part of our samples have been measured at this lab in the past. Change of lab would be detrimental to the quality of the study. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI contracting office by 1:00 PM ET on September 2, 2008. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Melissa Marino, Contract Specialist at marinome@mail.nih.gov. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference NCI-80201-MM on all correspondence.
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B -- Analyzing Helicobacter Species (H. species) and Biliary Tract Cancer