Notice Number: NOT-AI-14-037

Key Dates
Release Date: February 12, 2014
Response Date: February 24, 2014

Related Announcements
None

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

NIAID is seeking information from diagnostics product developers interested in supporting the advanced development of integrated clinical sample-to-answer multiplex diagnostic technologies to detect emerging and re-emerging infectious diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx) including NIAID Category A-C Priority Pathogens and other common medically-important pathogens directly from a blood sample, without a blood culture step. The primary focus of this Request for Information (RFI) is to gather information about the current product development status of the integrated instrument and potential multiplex diagnostic test. Areas of greatest interest include diagnostics with the following features:

• Multiplex diagnostic products designed for use in a primary healthcare setting, which may include one or more of the following: hospital laboratory, physician’s office, health clinics, emergency department, at the bedside, and/or low resource settings;
• The multiplex platform will consist of an instrument and multiplex diagnostic test(s) performed using the instrument. The instrument may be a single operating unit capable of accepting a clinical sample, or be composed of a cartridge and cartridge-operating unit. A cartridge is any small modular unit designed to be inserted into a larger piece of equipment; and
• The instrument should have all components and subsystems (blood sample processing, analyte detection, test result determination and reporting, etc.) completely automated and integrated into an operational unit that does not require any manual manipulation steps after the clinical sample has been loaded on the platform. For example, performance of the diagnostic test must not require manual steps to process and analyze the sample after the blood sample has been transferred from the clinical sample collection container (blood collection tube, etc.) into the entry component of the multiplex diagnostic platform. The entry component may be a tube, cartridge, injection port, or other receptacle into which the clinical sample is transferred to initiate the first processing step within the instrument. Examples of excluded manual steps include shaking, mixing, vortexing, heating, freezing, centrifuging, transferring partially processed samples into new containers (tubes, plates), and/or transferring the sample from one instrument to another instrument.

Background

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to understand, diagnose, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents with the exception of the Human Immunodeficiency Virus (HIV). This includes basic and applied research to develop and evaluate medical diagnostics, therapeutics and vaccines which are funded through a variety of research grants and contracts. The NIAID also has a mission to advance the development of new medical countermeasures (MCM) against biological agents that are most likely to be used in a terror attack on civilian populations.

Information Requested

Organizations are invited to submit a white paper describing their research efforts towards developing an integrated clinical sample-to-answer multiplex diagnostic product to detect Bacillus anthracis, Yersinia pestis, Francisella tularensis and a minimum of two commonly diagnosed prevalent pathogens with similar early symptoms as the three required biothreat pathogens (fever, malaise, flu-like symptoms, etc.). The pathogens must be detected directly from a blood sample, without a blood culture step. The paper can include but is not limited to:

• A description of the integrated instrument, and if appropriate, the cartridge component;
• Stage of product development for the instrument, and if appropriate, the cartridge component;
• Stage of product development for any existing multiplex diagnostic tests capable of detecting Bacillus anthracis, Yersinia pestis, and Francisella tularensis and common prevalent pathogens directly from a blood sample, including the current status of analytical and clinical studies;
• Intended user setting(s);
• Data to support that the integrated sample-to-answer multiplex platform is appropriate for the intended use(s);
• Description of manufacturing capabilities; and
• Status of legal rights to the intellectual property or agreements associated with the instrument or diagnostic test.

Submitting a Response

Responses should be limited to 10 pages, not including the cover page, cover letter and table of contents.  Any proprietary information should be clearly identified as such and will be kept confidential as allowed by relevant federal law.  Submitted data and information will not be returned.

RFI response must include: 1) Name and title of the primary point of contact for the response; 2) Name and address of the Institution or Company; 3) Email address and phone number of the primary point of contact. Responses are due by February 24, 2014.

This RFI does not constitute a commitment, implied or otherwise, that the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) will take procurement action in this matter. This is not a solicitation for proposals, applications, proposal abstracts or quotations. The purpose of this RFI is to obtain knowledge and information to assess the current state of the science. Further, neither DHHS/NIH/NIAID nor the government will be responsible for any cost incurred in furnishing this information.

Inquiries

Inquiries and RFI responses should be directed to:

Jonathan Bryan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-3167
Email: [email protected]

Or:

Stanley A. Knight, Sr.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6289
Email: [email protected]