Evaluation of P16/K67 Dual Stained Slides as a Biomarker for Cervical Pre-cancer

National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis services to conduct manual interpretation of approximately 20,000 SurePath cervical slide preparations stained with the CINtec PLUS dual stain cytology kit from women enrolled in a study on cervical cancer screening and triage and return slides to the NCI biorepository from Ventana Medical Systems 1910 East Innovation Park Drive Tucson AZ 85755 USA. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1), using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541380 and the business size standard is $14.0 Million. 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 estimated to be twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. HPV testing alone or with cytology ("cotesting") is being introduced into primary screening. The multiplicity of new options creates confusion over how to best incorporate HPV testing. Because most HPV infections are harmless, additional triage tests must identify HPV-positive women at highest cancer risk and no best strategy has been identified. Cytologic staining for p16/ki67 is a promising assay to identify cervical precancers. The cellular protein p16 is upregulated in transforming HPV infections and serves as an HPV-type independent biomarker of cervical precancer. p16 immunostaining protocols have been developed for cervical cytology. The dual stain slides need to be evaluated by an experienced cytotechnologist, detection of a single dual stain positive cell on the slide is considered a positive result. NCI is conducting a larger study evaluating different biomarkers for cervical cancer screening. As part of this study, a large series of dual stain positive slides are created that need to be read by a cytotechnologist experienced with the dual stain cytology. Contractor Requirements The contractor shall perform the following tasks: 1. Read 20,000 cytology slides. For each slide, the reader shall document: - Slide and staining quality (sufficient, insufficient, and reasons for insufficiency) - Dual stain positivity (yes, no) - Estimated number of dual stain positive cells (semi-quantitative) 2. Send all results to NCI in an Excel spreadsheet 3. At the end of the contract, stained slides shall be shipped to the NCI repository at room temperature. The NCI and Division of Cancer Epidemiology and Genetics has conducted previous studies from the same population in which dual stained slides were read by the proposed contractor. The contractor is the developer of the assay and has the greatest experience with reading dual stain cytology. To achieve the proposed goals, it is important to have consistent evaluation of dual stained cells that allow pooling the existing data with the current study. Thus, Ventana Medical Systems is the only known source that can provide a p16/ki67 staining and reading service to meet the Government's needs at this time. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response 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 4 PM EST, on August 18, 2016. All responses and questions must be in writing and faxed +1 (555) 000-0000 or emailed to Reyes Rodriguez, 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: N02CP62651-57 on all correspondence.