This Pre-Solicitation opportunity was posted on August 26, 2013. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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CINtec p16 Histology reagents and ancillaries for 2,750 tests

Awarded

NCI-130135-TGFederal

Submission Closed09/09/2013, 04:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 325413

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AI Contract Overview

The National Cancer Institute's Division of Cancer Epidemiology and Genetics intends to procure CINtec p16 histology reagents and ancillaries for 2,750 tests on a sole source basis from Ventana Medical Systems. This firm fixed price contract supports research to evaluate how p16 staining improves the accuracy of cervical histology by comparing community pathologist results with an expert panel's consensus diagnosis from the Costa Rica Vaccine Trial. The period of performance for this acquisition is twelve months from the date of award. Ventana Medical Systems is identified as the only known provider of this specific p16 histology assay, with the technology protected by patents. The procurement is being processed under simplified acquisition procedures and falls under NAICS code 325413. While intended as a sole source award, the agency allowed for the submission of capability statements from other interested parties, including small businesses, until September 9, 2013.

General Info

Agency

N/A

Contract Value

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

MD, CRI

Set-Aside

NONE

Awardee

VENTANA MEDICAL SYSTEMS, INC

Award Issued Date

09/25/2013, 12:00:00 AM UTC

Documents

No documents available

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Timeline

PhaseAwarded

PostedAug 26

Presolicitation

AwardedSep 25

Contract was awarded

Submission Closed

09/09/2013, 04:00:00 PM UTC

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Organization & Contact Information

AgencyN/A

Contacts2 people available

OfficeN/A

Organization / Agency

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Office AddressN/A

Contacts

Terry GallowayContracting Officer

contact@example.gov

+1 (555) 000-0000

Seena NinanContracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Bethesda, MD 20892, UNITED STATES Description National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure on a sole source basis CINtec p16 Histology reagents and ancillaries for 2,750 tests from Ventana Medical Systems, 1910 East Innovation Park Drive, Tucson, AZ 85755. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325413 and the business size standard is 500 Employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The mission of DCEG is to conduct broad-based, high quality, high impact research to uncover the causes of cancer and the means of its prevention. DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies, and other appropriate bodies. The Division develops research resources and strategic partnerships in molecular epidemiology across NCI, NIH, and the global research community. Recently updated histology guidelines recommend interpretation of cervical histology with adjunctive p16 staining. It is currently unclear how p16 adjudication affects cervical histology in routine practice. In the Costa-Rica Vaccine Trial (CVT), disease endpoints were established by a panel of pathologists who provided consensus histology results. The DCEG plans to compare histology results from community pathologists with the consensus diagnosis from the expert pathology panel and evaluate the degree to which agreement improves when p16 is used to aid histological evaluation. To accomplish this the DCEG will conduct p16 histology staining of 2750 histological slides from the Costa Rica vaccine trial at the pathology laboratory in Guanacaste, to evaluate the value of p16 histology to improve accuracy of cervical histology. The Contractor shall supply CINtec p16 histology staining reagents and ancillaries for 2,750 tests. The NCI researchers have long-term experience conducting molecular studies of HPV-related cancers. The proposed vendor is the only known source providing a p16 histology assay. Based on the NCI's understanding of cervical cancer natural history, p16 is one of the most promising biomarkers for cervical precancer. Other reagents and ancillariess offered to detect cervical precancer are based on the detection of proliferation markers and lack the HPV-specific p16 component. Ventana Medical Systems is the only known provider of a p16 histology assay. The reagents and ancillaries are protected by patents and there are no commercial competitors providing similar assays. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The responses 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. Responses must be received in the contracting office by 11:00EST, on September 9, 2013. All responses and questions must be in writing and faxed 240-276-5401or emailed to Terry Galloway, Contracting Officer via electronic mail at contact@example.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. 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) through sam.gov. Reference: NCI-130135-TG on all correspondence.