National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Genitourinary Malignancies Branch (GMB) seeks to procure cytology slide staining, on a sole source basis, from Ventana Medical Systems of 1910 East Innovation Park Drive, Tucson AZ 85755

This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(1)(i) using simplified acquisition procedures for commercial acquisitions.  The North American Industry Classification System code is 541990 and the business size standard is $15.0M.

The purpose is to stain cytology slides from 9,800 individuals enrolled in NCI studies on cervical and anal cancer screening using the p16/Ki-67 dual stain assay. In addition, slides require manual scoring and interpretation and return to the NCI biorepository.

The U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), CGB, requires services to evaluate p16/K67 dual stain for triage of HPV-positive women and for post-colposcopy and post-treatment management.

Despite Human Papillomavirus (HPV) vaccines, screening will remain central for decades to control cervical cancer. Recently, HPV testing alone or with cytology was introduced in the U.S. as an alternative to cytology screening. However, most HPV infections are harmless and additional tests are required to identify women at highest cancer risk. With three options for primary screening, and without clear strategies for triage of screen-positive women, there is great confusion about the best approach. Also, increasing HPV vaccination coverage will lead to lower disease prevalence, and force new screening approaches. Therefore, DCEG requires evaluation of the performance of several promising biomarkers head-to-head in a screening population.

Concurrent p16 and Ki-67 staining on cytological slides is a specific marker for cervical precancers that eliminates the need for morphological evaluation of cytology slides. NCI is evaluating p16/Ki-67 dual stain cytology in several studies evaluating biomarkers for cervical and anal cancer screening. The NCI therefore requires the Contractor to stain, score and interpret a large series of cytology slides.

NCI shall ship cytology containers from the study sites to the Contractor, totaling 9,800. The NCI is responsible for these shipping costs of containers to the Contractor. For each container, the Contractor shall:

1. Create a slide and perform p16/ki67 staining according to the package insert of the CINtec assay. Staining shall be performed using the p16/Ki-67 dual stain assay CINtec Plus. Slides shall be labeled using the study IDs that will be provided with each shipment.

1. Provide a reader document:

• Slide and staining quality (sufficient, insufficient, according to the manufacturer’s instructions and reasons for insufficiency)
• Dual stain positivity (yes, no)
• Estimated number of dual stain positive cells (semi-quantitative)

1. Send all results to NCI in an Excel spreadsheet

1. Ship stained slides and cytology containers, at room temperature, to NCI repository located at the following address: NCI Frederick Central Repository Services, Leidos Biomedical Research, Inc., 4600 Wedgewood Blvd, Suite H, Frederick MD 21703, United States, Phone: 301-694-5911

The NCI researchers have long-term experience conducting molecular studies of HPV-related cancers. The proposed vendor is the only source providing a p16/ki67 staining. Based on NCI’s understanding of HPV natural history, p16/ki67 is one of the most promising biomarkers to triage HPV-positive individuals. Ventana Medical Systems is the only known provider of p16/ki67 staining. The assay is protected by patents (U.S. Patents US 6,709,832 & US 7,425,617) and there are no commercial competitors providing a p16/Ki-67 assay. Based on the aforementioned information, Ventana Medical systems is the sole known source capable of fulfilling the requirements of this procurement.

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 capability statement 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 12:00 PM ET, on July 22, 2021.  All responses and questions must be via email to Miguel Diaz, Contracting Officer at [email protected].  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.  In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: 75N91021Q00152 on all correspondence.