Investigation of collagen architecture in breat biopsy tissues
Short Title: Investigation of collagen architecture in breast biopsy tissues
Document Type: Presolicitation Notice
Solicitation Number: N02C052536-78
Posted Date: 3/2/2015
Response Date: 3/17/2015
Classification Code: Q301
NAICS Code: 541990
Contracting Office Address
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E140, Rockville, MD 20850, UNITED STATES
Description
National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis services to image previously reviewed and stained Hematoxylin and Eosin (H&E) slides using second-harmonic generation (SHG) microscopy and to quantify patterns of collagen alignment in these images in BREAST Stamp Project participants (n=154) from University of Wisconsin-Madison, 1111 Highland Ave Room 4533, Madison, WI 53705.
This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541990 and the business size standard is $15.0 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 twelve (12) months from date of award.
It has been determined there are no opportunities to acquire green products or services for this procurement.
Project background:
Women with the highest levels of mammographic breast density are at 4-fold increased risk of breast cancer, compared with women who have the lowest levels of density. Mammographic density reflects the amount of fibroglandular tissue in the breast, which is composed of fibroblasts, epithelial cells and connective tissue. Increased collagen content is characteristic of dense tissue. Collagen remodeling has been linked to development and progression of breast cancer in animal models, and among women, specific tumor associated collagen signatures (TACS) have been linked to breast cancer and disease specific survival. However, links between mammographic density, TACS and pathologic diagnosis (benign vs. cancer) have not been explored in epidemiologic studies.
Multiphoton second-harmonic generation (SHG) is a high-resolution microscopy technology that can image collagen fibers in live or fixed breast tissues, without special staining or labelling. These images can then be visually assessed for collagen (i.e., TACS) signatures and also assessed using a computer-assisted collagen curvelet transform fiber extraction algorithm (CT-FIRE), which enables automated quantitative analysis of collagen fiber length, angle and waviness from the SHG images of breast tissues.
Using these methods, this study will test whether collagen fiber signatures or patterns of collagen features are related to mammographic breast density and pathologic diagnosis within NCI's Breast Radiology Evaluation And Study of Tissues (BREAST) Stamp Project. The BREAST Stamp Project was designed to investigate molecular mechanisms that mediate associations of elevated mammographic density with cancer by studying volumetric density and corresponding clinical biopsy tissues from women undergoing diagnostic image-guided breast biopsies. The novel mammographic density measures collected in this project include quantitative measurements of density in small regions surrounding suspicious targets prior to clinical biopsy. This study design will allow the association of quantitative measurements of volumetric density at the biopsy site with collagen signatures and pathologic diagnosis to be determined, to test the hypothesis that stromal alterations are related to breast cancer and high density.
Contractor Requirements are:
Image multiple sections of previously reviewed and stained Hematoxylin and Eosin H&E slides using the state-of-the-art SHG microscopy tool for benign (n=77) and malignant (n=77) breast tissues from participants in the BREAST Stamp Project.
Following imaging, assess collagen architectural patterns using visual assessment for each study participant and assign each participant with a ‘Tumor Associated Collagen Signature' Score.
Following imaging, apply the algorithm CT-FIRE to quantitatively assess collagen architectural patterns, including collagen fiber length, angle and waviness.
Implement quality control (QC) measures for image processing and analysis and for collagen assessment analysis and to provide QC results.
Provide results including representative images, collagen TACS signatures, collagen fiber length, angle and waviness for these breast tissues from each study participant.
To return H&E analyzed slides to NCI upon completion of analysis.
Government Responsibilities
The NCI COR shall provide the Contractor with microscopic slides containing breast biopsy tissues previously stained for H&E from 154 BREAST Stamp Projects participants. The NCI COTR shall review the data following completion of the task.
Reporting Requirements and Deliverables
Deliverables: The contractor will provide receipt of all the slides that are shipped. The Contractor will provide electronic data and analytic results outlined above. Electronic data may be submitted using Excel spreadsheets.
The Contractor will return the H&E stained breast biopsy tissue slides to NCI following completion of the analysis in light protected boxes at room temperature.
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 1 PM EST, on March 17, 2015. All responses and questions must be via email to Francisco Mendoza, Contracting Specialist at francisco.mendoza@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. 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: N02C052536-78 on all correspondence.
Francisco Mendoza, Phone 2402765668, Email francisco.mendoza@nih.gov
