The U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis, services for Digital Scanning of Cytology Slides and Automated Detection of Dual-Stained Cells, from Steinbeis GmbH & Co. KG für Technologietransfer, Heckerstr. 9 Heidelberg, Baden-Württemberg, Germany 69124.

This acquisition will be processed in accordance with simplified acquisitions procedures as stated in FAR Part 13.106-1(b)(1) and is exempt for the requirements of FAR Part 6. 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 shall be 12 months from the date of award. It has been determined there are no opportunities to acquire green products or services for this procurement.

BACKGROUND

Research over the past 20 years has identified human papillomaviruses (HPV) as the necessary cause of cervical cancer. About 13-15 carcinogenic types may cause cancer. However, HPV infections are very common among sexually active women and only a small subset progresses to cervical cancer. NCI/ DCEG is conducting studies to analyze biomarkers for cervical precancers and to study their performance for triaging HPV-positive women.

One of the assays NCI/ DCEG is evaluating is p16/ki67 immunostaining, which is conducted on cytology slides. Cervical cells are stained with two antibodies, directed against p16 and ki67, which in conjunction specifically indicate cervical precancers. The assay is considered positive if any dual stained cell is detected on the slide. Currently, the evaluation of p16/ki67stained slides is manual, which is subjective and time-consuming. In collaboration with the University of Heidelberg, NCI/ DCEG researchers have developed an approach for automated scanning of cytology slides and automated detection of dual-stain positive cells.

NCI/ DCEG wants to use this approach on a large series of dual stain slides from HPV-positive women to evaluate the performance of the approach for triage of HPV-positive in cervical cancer screening.

TASKS

The Contractor shall perform full slide scanning of 3,000 cytology slides stained with p16/ki67, digital archiving of the slides, and automated evaluation for p16/ki67 double stained cells. Specifically, the Contractor shall:
 
1. Perform full-slide scanning of p16/ki67 stained cytology slides
2. Provide access to scanned slides via the internet
3. Run automated algorithms for detection and quantification of dual stained cells
4. Provide results of automated slide evaluation to NCI/ DCEG

The proposed contractor, together with the NCI, has developed an approach for digital scanning and evaluation of dual-stained cervical cytology slides. Furthermore, an algorithm was developed for detection of dual stained slides on scanned cytology images. There is no other provider available that offers these services. Currently available slide scanners are primarily used for histology and do not perform well at focusing on cytology slides; therefore, no substitutions are available. In addition, there is no other known automated algorithm for detection of p16 and Ki-67 staining on cytology slides. Thus, the proposed contractor is uniquely qualified to perform these services.

This is not a solicitation for competitive quotations. However, if any interested party, especially small business, believes they can meet the above requirement, they may submit a capability statement, proposal, or quotation which will be considered by the agency. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. Reponses must be submitted via email only to Contract Specialist, Megan Kisamore, at [email protected], no later than 11:00 am EST, Monday, August 3, 2015. All questions must be emailed to [email protected]. Capability statements will not be accepted after the due date. 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 System for Award Management (SAM) at www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP52654-85 on all correspondence.

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