SOLICITATION NOTICE
Q -- Laboratory services to examine TMEM and Mena signatures
- Notice Date
- 9/12/2016
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP62716-63
- Archive Date
- 10/1/2016
- Point of Contact
- Seena Ninan, Phone: 2402765419
- E-Mail Address
-
seena.ninan@nih.gov
(seena.ninan@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB), plans to procure on a sole source basis services to examine TMEM and Mena signatures within a case-control study of patients with ER-positive breast cancer from MetaStat, Inc.; 27 Drydock Ave., 2nd Floor; Boston, MA 02210-2377 The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in 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 621511 and the business size standard is $32.5M. 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 12-months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Division of Cancer Epidemiology and Genetics (DCEG) is a research program of the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). The Division is the world's most comprehensive cancer epidemiology research group. Its renowned epidemiologists, geneticists, and biostatisticians conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The Division's research impacts public health policy in the United States and around the world. MEB's research mission is to define causal relationships between diet, energy balance, hormones, tobacco, and cancer. The MEB conducts interdisciplinary research to understand the role of diet, energy balance, hormones, tobacco, and other exposures in causing and preventing cancer. It studies how these exposures relate to a broad variety of cancers with researchers focusing on breast, colon, endometrium, esophagus, liver, stomach, ovary, pancreas, and prostate. It uses traditional epidemiological methods combined with a variety of molecular methods including genomic analysis, metabolomics, microbiomics, and molecular pathology. One of the main clinical challenges facing women with breast cancer is the risk of developing metastatic disease, which is the leading cause of death amongst those diagnosed. The tissue microenvironment of metastasis (TMEM) is an assay that aims to determine the risk for metastatic spread within a tumor. It takes advantage of the functional characteristics of the intravasation steps of the metastasis process. Intravasation is the key stage that allows tumor cells to enter into the bloodstream where they then subsequently disseminate around the body. TMEM describes the sites of interaction between tumor cells, blood vessels and macrophages within the tumor tissue microenvironment. The relationship between TMEM and breast cancer has been investigated in two prior studies. In the largest study to date, a case-control study of 481 patients of all breast cancer molecular subtypes, a significant association between women with the highest levels of TMEM and increased risk of distant metastasis compared to women with the lowest levels of TMEM was found. Stratified analysis of their findings according to breast cancer molecular subtype revealed a stronger association between TMEM score and increased risk of metastasis among the estrogen receptor (ER)-positive subgroup of patients. One of the key proteins involved in the TMEM signature is Mena. While assessment of Mena within TMEM examines total Mena expression, there are a number of different Mena isoforms, namely MenaINV and Mena11a both of which have distinct expression profiles in the metastatic setting.. MenaINV is expressed selectively in tumor cells that have an invasive phenotype, whereas expression of Mena11a is downregulated in this setting. An immunofluorescent based signature infers the proportion of Mena that contributes to the invasive phenotype by subtracting Mena11a from levels of total Mena. Findings which examined two independent cohorts found that high expression of this Mena signature was statistically significantly associated with worse patient outcome, independent of clinical characteristics. NCI investigators recently showed that ER-positive breast cancer patients who experienced declines (>8.5%) in their mammographic breast density, which is a radiological measure of the fibroglandular breast tissue, following adjuvant tamoxifen treatment had significantly improved outcomes as compared with women who did not experience density reductions. However, the molecular mechanisms underlying the relationship between tamoxifen-induced reductions in mammographic breast density and improved breast cancer prognosis remain unclear. Therefore, to expand and explore these findings at a molecular level, NCI aims to examine the TMEM and Mena signatures in the breast tumor tissues collected from the patients in this study. The Contractor will perform the assays to measure the TMEM and Mena signatures. NCI aims to determine if TMEM and Mena signatures are predictive of breast cancer outcomes and to determine if TMEM can predict mammographic breast density change among women treated with adjuvant tamoxifen therapy. Contractor shall perform the following: A. TECHNICAL REQUIREMENTS: This study will be carried out using the previously identified case-control patient population. All women included in this study are patients diagnosed with invasive ER-positive breast cancer. The cases for this study include women who died of breast cancer and the controls include women who did not die from breast cancer. Controls have been previously identified and matched to cases on age at diagnosis, year at diagnosis and stage at diagnosis. 1. The NCI will provide the Contractor with whole formalin-fixed paraffin-embedded (FFPE) tissue sections from n=240 patients. The samples will be labeled with subject identification numbers only; patient identifiers will not be supplied. NCI will provide a specimen manifest in the shipment. Upon receipt, the Contractor shall inventory the tissue samples in order to confirm that the identification numbers and number of samples match that in the specimen manifest. The Contractor shall notify the Contracting Officer's Representative (COR) of any discrepancies between the specimen manifest and specimens received within one week of shipment receipt. 2. After receiving the specimens, the Contractor shall: a. Perform analysis to determine the presence of TMEM on tissue sections (n=240). i. Staining: An automated immunohistochemistry based test shall be performed on the supplied FFPE tissue sections. ii. Analysis: The Contractor shall perform digital pathology and image analysis methods to identify and quantify TMEM as the combined expression of markers of tumor cell invasion (Mena protein), blood vessels (CD31) and macrophages (CD68). b. Perform a fully automated quantitative immunofluorescence assay to determine the Mena signature, an assay that evaluates the expression of Mena protein and its isoforms to determine tumor aggressiveness on tissue sections (n=240). i. Staining: A fully automated quantitative immunofluorescence assay will be performed on the supplied FFPE tissue sections to evaluate the expression of Mena protein and its isoforms. ii. Analysis: The Contractor shall perform digital pathology and image analysis methods to identify and quantify Mena signatures. 3. The Contractor shall perform assays under conditions of careful quality control (QC), following the Contractor's usual laboratory QC procedures and providing all internal QC results for the assays and the image analysis to the NCI COR. 4. The Contractor shall notify the NCI COR within three days of the occurrence of any unusual problems that might affect or delay the completion of this project, such as failure of analytic or quality control procedures, breakdown of instrumentation and equipment, or changes in laboratory personnel. 5. The Contractor shall provide the assay results within an Excel spreadsheet within the period of the contract. NCI will specify a secure FTP address where the data is to be uploaded. 6. Upon completion of the assays, the Contractor shall return the stained tissue sections and related digitized images to an NCI biospecimen repository designated by the COR. B. REPORTING AND/OR DELIVERABLES: The contractor shall deliver to NCI, no later than 12 months from the date of award, results from the TMEM and Mena protein assays and QC results within an electronic Excel spreadsheet, with data identified only by unique study identification number (ID). In addition, digitized images of the tissue sections shall be delivered to the NCI COR. C. GOVERNMENT RESPONSIBILITIES: The NCI will ship the tissue samples to the Contractor via Fed Ex. The NCI will provide a specimen manifest in the shipment and will e-mail the Contractor an electronic copy of the shipment manifest. The NCI COR will send the specimens to the Contractor in the order in which the specimens shall be analyzed. The NCI COR will designate the name, address, and any other required information for the NCI biospecimen repository to which the specimens should be returned upon completion of the project. The NCI COR will review and approve all results. MetaStat is the only known company that has developed an automated tissue staining protocol for assessment of TMEM and is the only known available source with validated automated technology to assess both TMEM and MenaCalc in breast cancer tissue. Further one of the main antibodies used for detection of this signature was developed by an individual who is part of MetaStat's Scientific and Clinical Advisory Board. The antibody is currently licensed to MetaStat, who is developing the TMEM test and other tests for commercial use and so is not commercially available from other contractors. Additionally, MetaStat is the only contractor that has developed automated methods for identification and quantification of TMEM. TMEM is a mechanistic based assay that requires extensive pathological QC review, all of which is provided by MetaStat who works alongside pathologists who have extensive experience in the assessment of TMEM. The facilities at MetaStat include a CLIA-certified diagnostic laboratory. It is therefore critical to contract with MetaStat to analyze the NCI samples due to the unique expertise and technologies housed at MetaStat and to ensure consistency and validity of the findings. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 10:00AM EDT, on Sept. 16, 2016. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Seena Ninan, Contracting Officer via electronic mail at ninans@mail.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. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02CP62716-63 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP62716-63/listing.html)
- Record
- SN04266229-W 20160914/160912234454-480123b9a44895e46bac644ee42bbf93 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |