D1 Purchase Description.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

View RNA ISH cell assay kit (Brand-name or equal)

1. Statement of Need and Purpose: The Therapeutic Development Branch (TDB), Biology Team, within the National Center for Advancing Translational Sciences (NCATS) seeks to purchase a in situ hybridization (ISH) RNA cell assay kit to screen NCATS

Pharmacologically Active Chemical Toolbox (NPACT) and Library of Pharmacologically

Active Compounds (LOPAC) libraries for activators of JAG1 mRNA which are potential therapeutic target for Alagille syndrome (ALGS), an ultra-rare genetic disorders.

2. Background Information and Objective: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek 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, conducting, supporting and making medical discoveries that improve people’s health and save lives.

NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The goal of the NCATS Therapeutic Development Branch (TDB) is to help close the gap between basic research and preclinical testing of new small-molecule and biologic drugs, as well as cell-based and gene therapies. Work spans the entire preclinical development pipeline, including medicinal chemistry, toxicology, formulation, and other studies required to support an Investigational New Drug (IND) application to the U.S.

Food and Drug Administration (FDA).

As part of NCATS Cooperative Research and Development Agreement (CRADA) for

Alagille syndrome (ALGS), NCATS is responsible to develop cell assays, screen libraries and further develop the therapeutic target for ALGS.

The in situ hybridization (ISH) techniques are used to visualize DNA or localize RNAs within cells. Whereas in situ analysis of RNA has traditionally been limited by low sensitivity and complicated probe synthesis, the ISH cell assay is based on highly specific branched DNA signal amplification technology, providing robust in situ detection of one or two target mRNAs within cells with single-copy sensitivity.

Thus, NCATS TDB requires the View RNA ISH cell assay kit (Brand-name or equal) to further advance the research on NCATS CRADA ALGS agreement by screening NCATS

NPACT and LOPAC libraries for activators of JAG1 mRNA which are potential therapeutic ALGS.

3. Generic Name of Product: In situ hybridization (ISH) RNA cell assay kit

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

4. Purchase Description:

Product’s brand name Manufacturer Catalog

Number

Quantity

VIEW ISH CELL ASSAY KIT Thermo Fisher Scientific QVC0001 18

5. Salient characteristics: The salient physical, functional, or performance characteristics that “equal” products must meet are as follows:

a. Highly specific branched DNA signal amplification technology.

b. Provides robust in situ detection of one or two target mRNAs within cells with single-copy sensitivity.

c. Enables direct visualization and quantitation of target genes in cells.

d. Four primary steps:

a. Sample preparation.

b. Target hybridization.

c. Signal amplification using branched DNA (bDNA) technology, and

d. Detection.

e. Sufficient materials to perform 24 1-plex to 3-plex assays in a 24-well plate format, per kit.

6. Quantity: Eighteen (18) ViewRNA ISH Cell Assay kit or Equal.

7. Delivery Date: Delivery is expected within 30 days after contractor receipt of order

(ARO). Delivery shall be FOB Destination and shall be delivered to 9800 Medical Center

Drive, Rockville, MD, 20850 between the hours of 8:00 am and 5:00 pm, Eastern

Standard Time, Monday through Friday (except on Federal Holidays).