SOLICITATION NOTICE
Q -- Evaluatio of p16/ki67 cytology to detect cervical precancer
- Notice Date
- 7/22/2010
- 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-100138-TG
- Archive Date
- 8/17/2010
- Point of Contact
- Terry Galloway, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
gallowaytl@mail.nih.gov, cr214i@nih.gov
(gallowaytl@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure on a sole source basis the evaluation of p16/ki67 cytology to detect cervical precancer from mtm Laboratories AG, BioPark, Im Neuenheimer Feld 583, D-69120 Heidelberg, Germany. The supplies and services herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b)(1). The North American Industry Classification System code is 541380 and the business size standard is $12 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Period of Performance shall be for twelve (12) months from date of award. Research over the past 20 years has identified human papillomaviruses (HPV) as the necessary cause of cervical cancer. However, HPV infections are very common among sexually active women and only a small subset progresses to cervical cancer. The p16/ki67 is a marker of HPV-related transformation and indicates cervical precancer, the endpoint of current screening programs. While HPV testing is a very sensitive marker of cervical precancer it lacks specificity and additional markers are required to identify women at highest risk of precancer and cancer. Several studies in DCEG are now evaluating markers of HPV transformation to better understand the progression from HPV infection to precancer and to identify new biomarkers for cervical cancer screening. The contractor shall perform p16/ki67 cytology as marker of cervical precancer in two DCEG-based studies, the Costa Rica Vaccine Trial and the Nigeria Screening Study, for a total of 2,500 samples. The contractor shall create cytologic slides from specimens collected in both studies, stain them with a p16/ki67 double stain, and evaluate the slides for p16/ki67 stained cells to determine the performance of p16/ki67 to detect cervical precancer. 1650 samples will be sent within 30 days of contract award in two shipments and the remaining 850 samples will be sent by Fall 2010. Mtm Laboratories AG is the only known source, protected by patents, providing a p16/ki67 detection assay. Based on an understanding of cervical cancer natural history, p16 is one of the most promising biomarkers for cervical precancer. The unique combination of p16, a specific marker of HPV oncogene action, and ki67, a proliferation marker, offers high specificity for detection of cervical precancer. Other assays offered to detect cervical precancer are based on the detection of proliferation markers alone and lack the HPV-specific p16 component. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, 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 the requirement. Capability statements must be received in the contracting office by 11:00 AM EST, on August 2, 2010. For further information, please contact Terry Galloway, Contract Specialist via electronic mail at gallowaytl@mail.nih.gov. 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. No collect calls will be accepted. No faxed or emailed capability statements will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Reference: NCI-100138-TG on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-100138-TG/listing.html)
- Record
- SN02214837-W 20100724/100722235212-7d96d7f7b8f5e7a4e27092f0e3a5b2b9 (fbodaily.com)
- Source
-
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