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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 18, 2016 FBO #5229
SOLICITATION NOTICE

B -- Fluorescence Intensity Quantitation in GNE Myopathy Muscle Slides

Notice Date

3/16/2016
 

Notice Type

Presolicitation
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 

ZIP Code

20892-7902
 

Solicitation Number

HHS-NIH-NHLBI-CSB-(HG)-2016-100-DM
 

Archive Date

4/6/2016
 

Point of Contact

Dorothy Maxwell, Phone: 301-435-0352
 

E-Mail Address

maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a non-competitive sole source basis to Definiens Inc., 1719 State Route 10, Suite 118, Parsippany, New Jersey 07054-4539 to procure Procurement: 1. Testing for Fluorescence Intensity Quantitation in GNE Myopathy Muscle Slides, Custom Research Solutions, Part Number: C-40-00-20010, Quantity: One; Phase 1. 2. Testing for Fluorescence Intensity Quantitation in GNE Myopathy Muscle Slides, Custom Research Solutions, Part Number: C-40-00-20010, Quantity: One; Phase 2. Background: The National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency seeking fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Human Genome Research Institute (NHGRI), mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. The NHGRI/Medical Genetics Branch (MGB) seeks to identify and understand inherited disorders of metabolism and of human development. MGB investigators focus on human genetics, vertebrate embryology, inborn errors of metabolism, and neurogenetic disorders. Projects performed at the biochemical, molecular, and cell biological levels involve the direct study of human subjects as well as the development and use of experimental model systems, such as zebrafish and mouse. Studies of these rare patients and populations have proven invaluable for advancing the mission of the Branch. Definiens imaging analysis is experienced in biomarker and morphological profiling as required for this study. They have experience in handling biological and staining variability, as present in our muscle images (only muscle membrane staining and not other non-specific tissue attaining- needs to be quantified in our muscle biopsy sections). Definiens Tissue Studio-based analysis incorporates machine learning, pattern recognition and auto object based image analysis algorithm. It accurately detects regions of interest and distinguishes cell types and cell subtypes within target regions across any number of tissue slides. It determines morphology and expression profiles per individual cell or cell compartment, which is what we need for muscle membrane quantitation. Purpose and Objectives: The purpose of this procurement is for 10 muscle biopsy slides to be stained with two different lectins and identify a number of lectin-based biomarkers in muscle biopsy sections. The research study being conducted is to identify a number of lectin-based biomarkers in muscle biopsy sections to help in characterizing treatment versus response in patients. It has been shown that there is an increase in the staining intensity for certain lectins after treatment when compared to controls. It will help us in moving forward in establishing an outcome parameter for treatment. In the research lab it is qualitatively shown that lectin staining of GNE myopathy patient muscle sections is informative for diagnosis and for response to therapy. However, it is unknown the extent of capabilities, experience (including specific software) that Definiens has to quantify membrane-bound fluorescence signals in these images. Quantitation performed by an outside research company assures unbiased result interpretation. Other Considerations: The purpose of this study is to quantify lectin and antibody fluorescence signals in 10 muscle biopsy slides to help identify (bio)markers that aid in diagnosis and in response to ManNAc therapy in GNE myopathy patients. Qualitative fluorescence imaging shows decreased staining intensity for sialic acid-binding lectins in GNE Myopathy muscle sections compared to controls; after ManNAc treatment this intensity increases. This project will quantify this staining effect. It will help us establish an outcome parameter for ManNAc treatment in GNE Myopathy. Definiens imaging analysis is the solution of choice for biomarker and morphological profiling as required for this study. Through its unique ability to overcome inherent biological and staining variability, Definiens Tissue Studio-based analysis incorporates machine learning, pattern recognition and auto object based image analysis algorithm. It accurately detects regions of interest and distinguishes cell types and cell subtypes within target regions across any number of tissue slides. It determines morphology and expression profiles per individual cell or cell compartment, solving your most challenging biological questions. Definiens imaging platform supports applications for single or multiplexed immunohistochemistry (IHC), immunofluorescence (IF), and in-situ hybridization (ISH) in the areas of oncology, immunology, angiogenesis, metabolic disorders, toxicology, and helps in designing and implementing more efficient clinical trials by reducing time and cost. It improves sample selection for molecular tests and ensures greater test sensitivity and robustness to improve patient stratifications and clinical trial decisions. Definiens can perform comprehensive and consistent data from any tissue based assay : • Object based image analysis; • Unique machine learning and auto adaptive algorithms; • Accurately measures nuclear, membrane, and cytoplasmic biomarkers; • Multiple workflows offering dual IHC stain support; • Provides automated spot detection and analysis for FISH, CISH, SISH and Dual CISH; • Provides multi-parametric cell-by-cell quantification; • Enables simple robust detection of regions of interest (ROI); • Highly flexible support of all standard IHC tissue stains (choose any chromogen color), H&E, and IF; • Supports all tissue formats including whole slides and TMAs; • Enables rapid, batch parallel processing of images; • Generates hundreds of unique image feature measurements; • Simple user interface; • Integrates with image management databases; and • Supports and integrates seamlessly with the majority of commercially available slide scanners. Anticipated Period of Performance : 3-Months Upon Award Regulatory Authority: This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source and is not expected to exceed the simplified acquisition threshold, only one responsible source and no other supplies or services will satisfy agency requirements. Statutory Authority : This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. This requirement will be under the Simplified Acquisition Threshold $150,000.00 Additional Information: Industry Classification (NAICS) Code is 334516, Analytical Laboratory Instrument Manufacturing and small business size standard is 500. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-87-1 (March 16, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." 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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by March 22, 2016 and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2016-100-DM by 7:30 a.m. Eastern Time, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell, Contracting Officer. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2016-100-DM/listing.html)
 

Place of Performance

Address: NIH Clinical Center, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN04052635-W 20160318/160316235435-60d2e8b0f9375e39dfb4023113a7d80b (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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