Title: The Breast Radiology Evaluation and Study of Tissues (BREAST) Stamp Project:  Quantification of telomere lengths in breast biopsy tissues

            Document Type: Pre-solicitation notice

            Solicitation Number:  N02CP42618-62

            Proposed Posted Date:  August 13, 2014

            Proposed Response Date:  August 28, 2014 11:00AM EST

            Classification Code:  Q301

            NAICS Code:  541380

            Small Business Size Standard:  500

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room1E144,    

Bethesda, MD 20892 USA

Description:

The National Cancer Institute (NCI), Division of Cancer and Epidemiology (DCEG) plans to procure on a sole source basis to Johns Hopkins at 1503 Jefferson Street Bond Street Annex, Room 300 Baltimore, MD 21231 for the quantification of telomere lengths in breast biopsy tissues.

This acquisition will be processed in accordance with the simplified acquisition procedures as authorized by 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 541380 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.

Period of performance will be 12 months from award.

The BREAST Stamp Project aims to define the molecular pathology and biology of mammographic density, one of the strongest breast cancer risk factors.  Although elevated mammographic density is related to up to a fivefold increase in breast cancer risk compared with low density, the vast majority of women with dense breasts do not develop cancer and women with low density account for about half of all breast cancers in the U.S.  To better understand mammographic density at the tissue level, fixed tissue sections from each BREAST Stamp Project participant’s breast biopsy were collected and are being analyzed for multiple histological parameters, both by visual analysis and using computer-based image analysis.  No prior study has related telomere lengths in breast tissues to mammographic density.  

Telomeres are nucleoprotein structures composed of repetitive DNA sequences (TTAGGG) and the shelterin protein complex. They cap the ends of chromosomes and help maintain genetic stability. TTAGGG repeats are lost during cell division, shortening telomeric DNA. When the telomeric DNA reaches a critical length, cells may undergo senescence, apoptosis or, if tumor suppressive mechanisms are abrogated, neoplastic transformation. Shorter telomeres have been observed in breast epithelial tumor cells compared with adjacent non-malignant tissue, with the shortest telomeres associated with the most aggressive subtypes of breast cancer, suggesting that shortening of telomeres may be an early event during the carcinogenic process.

The purpose of this requirement is to work with the Contractor to scan and generate digitized images of the Q-FISH stained breast biopsy tissues to allow for analysis and quantification of the telomere lengths in breast tissue images in a subset (n=175) of BREAST Stamp participants whose Q-FISH stained tissues have been deemed suitable for image analysis.  This requirement will allow for analysis relating breast tissue telomere lengths to telomere lengths in blood DNA as well as to mammographic density, features of TDLUs and biopsy diagnosis.  The proposed project may contribute to our understanding of the molecular pathology of density, which may help refine risk assessments based on density alone.

Johns Hopkins Medical Institutions (JHMI) has unique qualifications to perform this work. JHMI pioneered the method of Q-FISH for telomere length assessment in paraffin-embedded tissues; they have extensive experience in systematically and comprehensively analyzing breast tissue images to measure quantitative telomere lengths, with demonstrated relationships with prognosis.  In addition, JHMI has previously demonstrated the feasibility of applying the Q-FISH stains to whole slide images of normal and malignant breast tissue from participants in the BREAST Stamp Project. JHMI has performed similar work on benign endometrial tissues; a value-added component of this study will be to compare results from the normal breast structures and normal endometrial tissues analyzed in our NCI studies. Therefore, for continuity, it is critical that JHMI analyze these samples in order to maximize the internal validity of NCI’s datasets.

This is not a solicitation for competitive quotations.  However, if any interested party, especially a small business, believes they can meet the above requirement, they may submit a statement of capabilities and or quote.   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.  An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on August 28, 2014. Electronic capability statements will be accepted (i.e. email or fax). An original and one copy must be sent to the NCI Office of Acquisitions at the address stated above.  All questions must be in writing and can be faxed to (240) -276-5401 or emailed to Tiffany Kittrell, Contract Specialist, at [email protected]. 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) www.sam.gov.  No collect calls will be accepted. Please reference solicitation number N02CP42618-62 on all correspondence.