Amendment_4_for_BARDA-CBRN-BAA-12-100-SOL-00011.pdf

AMENDMENT TO BARDA BROAD AGENCY ANNOUNCEMENT

ADVANCED DEVELOPMENT OF CHEMICAL, BIOLOGICAL, !RADIOLOGICAL, AND

NUCLEAR MEDICAL COUNTERMEASURES

Broad Agency Announcement Number: BARDA-CBRN-BAA-12-1 OO-SOL-00011

Amendment Number:

Amendment Posting Date:

Issued By:

Point of Contact:

May 1,2013

Biomedical Advanced Hesearch and Development Authority (BARDA)

330 Independence Ave., SW, Room G640

Washington, D.C. 2020 '1

Primary Point of Contact:

Thomas P. Hastings-

Contracting Officer thomas. hastings @hhs-=.9..QY

Phone: 202-720-2823

Secondary Point of Contact:

Matthew A. McCord, Contract Specialist matthew.mccord@hhs.QQY

Phone: 202-260-0689 mailto:matthew.mccord@hhs.QQY

SUMMARY OF CHANGES

A. PURPOSE: The purpose of this Amendment 4 to BARDA-CBRN-BAA-12-100-S0L 00011 is to delete Area of Interest #6: Diagnostics , on Page 13 under PART 1 Research Areas of Interest, and replace it with the following information contained below.

B. Except as provided herein, all other terms and conditions of I3ARDA-CBRN-BAA-12 100-S0L-00011 remain unchanged . .

Area of Interest #6: Diagnostics:

Design and production of the system in area of interest #6 must be compliant with U.S. Quality

Systems Regulations (21 CFR Part 820)

Biodosimetry Diagnostics :

6.1 Development of a dosimetry self assessment tool for exposures to ionizing radiation at or greater than 2 Gy.

6.2 Development, clinical evaluation , and/or FDA ("agency") clearance of rapid diagnostic systems for determining white blood cell counts from whole blood. These systems should be portable and designed for ease of use by non-expert personnel at point-of-care .

6.3 Biodosimetry Systems -BARDA is interested in white papers based on previously unfunded biodosimetry technologies such as: Metabolomics, Optically Stimulated Luminescence, .

MicroRNA, Premature Chromosome Condensation , or Fluorescence Activated Cell Sorting .

BARDA is not interested at this time in receiving white papers based on currently funded biodosimetry technologies such as: Gene or Protein Expression Changes , Cell micronuclei , Protein Concentration in the Aqueous Humor, Volatile Organic Compounds in Breath , and .

Electron Paramagnetic Resonance.

In these previously unfunded technologies, BARDA is interested in development of a rapid point-of-care diagnostic or centralized high-throughput assay systems for assessing absorbed doses of ionizing radiation in the range of 0.5 Gy to 10 Gy that have robust detection signal from 24 hours post-exposure and persists at least one (1) week. The assay system should provide the assessment of the absorbed dose for biodosirnetry applications with high sensitivity and specificity. It is preferred for high throughput assays to be developed/optimized for use with existing diagnostic instrument platforms which have a large number of US Clinical lab placements and for point-of-care platforms to be CLiA-waived .

6.4. Development of an improvement on the current "gold standard" for assessing absorbed doses of ionizing radiation (the dicentric chromosomal assays (DCA)) in terms of ease of use, .

time for performance, statistical certainty of dose, improved dose range, and biomarker lifespan.

Bio-threat agent Diagnostics:

6.5 Development of an anthrax diagnostic assay system (may be part of a multi-pathogen panel) :

6.5.1 Development, clinical evaluation , and/or FDA ("agency") clearance/approval of rapid , accurate diagnostic systems for determining anthrax infection. These systems should be portable and designed for ease-of-use by non-expert personnel at point-of-care (POC) settings. It is preferred that these poe systems be ellA-waived; at most they should be ellA moderately-complex (as opposed to highly complex assay systems) . .

6.5.2 Development, clinical evaluation, and/or FDA ("agency") clearance of centralized , high-throughput diagnostic assay systems for determining

. anthrax infection. It is preferred for high throughput assays to be developed and optimized for use with existing diagnostic instrument platforms that have a large number of US clinical laboratory placements, for use with at least one FDA-cleared "routine health-care" assay. BARDA will consider offers if the platform is not cleared to market, but is actively engaged in the clearc3nce/approval process.

For the above, Offerors should provide adequate proof-of-concept data for both proposed assays and platforms-including analytical sensitivity (with limits of detection less than bacteremia levels of 250 CFU/mL), specificity, reproducibility, linearity and dynamic range in relevant clinical matrices, such as whole blood. Mature data packages will receive higher consideration. (Platform performance data may include testing with surrogate agents, e.g. B. cereus, or relevant "routine health-care" assays).

BARDA is not interested in white papers or proposals that fail to include conVincing proof of concept data.

6.6 Hardware platform development:

6.6.1 In vitro diagnostic (IVD) devices that would provide rapid, accurate point of-care (POC) / "field-use" testing of the civilian population (including special populations) and results-reporting after a large scale incident resulting in exposure to bio-threat agents of interest POC platforms should be capable of use at or near the point of need, such as doctors' offices, hospital emergency room labs, or more austere environments such as in a mobile deployable hospital, school gymnasium, or tent near the site of a bio-threat agent incident. Ideally, these devices would be capable of performing bio-threat and routine healthcare use assays. In addition, these essential elements are sought:

30 minutes (15 minutes preferred) .

4. CLiA waive-able or alternatively able to achieve CLiA moderate complexity

5. Ability to be operated in non-temperature/humidity controlled environments.

6.6.2 New and innovative sample preparation technologies needed for collecting and processing clinical samples potentially containing biothreat agents of interest for use at point of care.

6.7 Fundamental"Bio-threat Agent of Interest" Knowledge Dev'3Iopment:

6.7:1 Characterization of pathogen- or disease- specific markers and their relationship to the diagnostic window of opportunity and clinical utility in clinical samples. These studies should be designed to show the clinical relevance of the diagnostic assay, including determination of the most appropriate sample type and matrix.

6.7.2 Assay development of appropriate pathogen- or disease- specific markers including detection methods to provide greatest diagnostic utility.

6.7.3 Studies to inform the clinical effectiveness of the assay in pediatric, geriatric, and other special populations (including immunocompromised, . pregnant, and diabetic individuals).

Note 1: "Biothreat Agents of Interest" for sections 6.2 & 6.3 (listed alphabetically):

Bacillus anthracis (Anthrax), Botulinum toxin (Botulism), Burkholderia mallei (Glanders) and Burkholderia pseudomallei (Melioidosis), Filoviruses ( Ebola &Marburg), Francisella tularensis (Tularemia), Rickettsia prowazekii (Typhus), Yersinia pestis (Plague)

Note 2: Animal samples, if required for these studies, will be provided as Government Furnished Material (GFM). .

. Chemical Agent Diagnostics:

Submissions for Chemical Agent Diagnostics will not be considered during the open period of this BAA, unless specifically announced through special instructions. Please monitor future special instructions for specifics on Chemical Agent Diagnostics areas of interest.

Technical Point of Contact: Mr. Rodney Wallace; rodney.wallace@hhs.gov mailto:rodney.wallace@hhs.gov