RFI 70RWMD26RFI00000002 Rapid Multiplex PCR Fieldable Detection.pdf

REQUEST FOR INFORMATION (RFI) 70RWMD26RFI00000002

Title: Rapid Multiplex PCR Fieldable Detection

NOTE: THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and market research planning purposes. This RFI shall not be construed as an obligation on the part of the Government. This is NOT a Request for Quotations or Proposals. No solicitation document exists, and the Government may or may not issue a formal solicitation as a result of the responses received to this RFI.

The Government will not pay for any response or demonstration expenses. All costs incurred responding to this RFI will be solely at the interested party's expense. Failure to respond to this RFI will not preclude participation in any future solicitation. Any information received will become the property of the Government and will not be returned to the submitter. Interested parties are responsible for adequately marking proprietary or sensitive information.

The Government’s explicit intent, in this request for information, is to not receive from respondents any proprietary data, trade secrets, business sensitive information, or information considered CONFIDENTIAL under 18 U.S.C. §1905. The Government’s constraint does not in any way relieve contractors from their responsibility to properly mark proprietary data when it is provided, nor does it alleviate any requirement for the Government to protect marked data. The Government is not obligated to protect unmarked data.

The information provided in this RFI is subject to change and is not binding on the Government. All submissions become the property of the Federal Government and will not be returned.

DESCRIPTION

The Department of Homeland Security (DHS) Countering Weapons of Mass Destruction Office’s (CWMD) mission is to enable operational partners to prevent weapons of mass destruction use against the Homeland and promote readiness for chemical, biological, radiological, and nuclear threats.

Recognizing opportunities for improvements in the current U.S. biosurveillance system, DHS CWMD is leading an effort to research and develop automated high throughput “gold standard” based fieldable biodetection technologies. DHS CWMD is committed to protecting the American people from biological threats by utilizing technological advancements and collaborating with Federal, State, Local, Tribal, Territorial (FSLTT) partners across the homeland security enterprise. The biological threat landscape intersects with defense and public health biological surveillance, requiring rapid and accurate sample processing, and detection/ identification of a biothreat as it relates to response of a biothreat incident.

PURPOSE OF THIS REQUEST FOR INFORMATION (RFI)

The DHS CWMD Office is conducting market research and seeks to understand the capabilities and level of interest of industry partners in the Research and Development (R&D) for a high throughput fieldable multiplexed PCR-based (or equivalent technology type) proof of concept device(s) that can independently collect & process 30 or more samples( in a serial manner), and detect, and identify five

(5) or more biological threat agents in 1 hour or less in the field/relevant outdoor environment.

The DHS CWMD Office wants to enhance their understanding of what methods and materiel solutions exist and can meet these needs regardless of their current technology readiness: from basic through applied research efforts. The DHS CWMD Office is interested in capabilities that cover detection and identification starting immediately upon a release (or contamination) through early healthcare diagnostics that speeds up the time to diagnosis and treatment.

In addition, the CWMD Office seeks to gain an understanding with a Rough Order of Magnitude (ROM) cost estimate and a general timeline duration.

INFORMATION REQUEST

Interested parties should submit responses addressing the following:

1. Description of proposed PCR-based or equivalent technologies (Including whether there are consumables, maintenance requirements and intervals, sensor density required for thorough coverage)

2. The timeliness of detection (How fast can a biothreat be detected?)

3. The timeliness of identification (How fast can a biothreat be identified?)

4. The timeliness of high throughput processing of samples (time per sample)?

5. Confidence level of detection/identification (Including sensitivity and specificity, how sensor distribution impacts confidence of a detection/identification)

6. What is capable of being detected and identified? (i.e. bacteria (vegetative and spores), viruses

(RNA and DNA), fungi (vegetative and spores), toxins (chemical and proteinaceous), etc.)

7. Types of sample matrices that can be utilized (aerosol, water, soil, etc.)

8. Volume of sample required

9. Concentration of sample needed to be detected (LOD; To include what should be allowable)

10. False alarm/positive rates (To include what should be an acceptable rate)

11. False negative rates

12. Environmental operational parameters (e.g. humidity, temperature, precipitation (rain, snow, sleet), inhibitors and obscurants

13. Cold chain requirements and other ‘logistical tails’

14. Describe trade space analysis of time to detect/identify vs. accuracy of detection/ identification

15. Describe ability to archive sample (s) for additional testing.

RESPONSES TO THE RFI

Interested parties should submit electronic responses to the point of contact identified below:

Ariana Thompson, Contract Specialist, Ariana.Thompson@hq.dhs.gov.

RFI responses should be in .docx format. Figure legends, labels, and table of contents may be no smaller than font size 8 as presented in Microsoft Word. Responses shall be limited to 10 pages inclusive of cover page containing respondent information. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. The subject line of the email should contain the RFI number (70RWMD26RFI00000002) and “Rapid Multiplex PCR Fieldable Detection.”

At a minimum, responses should include:

1. Company information: (name, phone number, UEI, CAGE Code, POC information, website, etc.).

2. GSA contract(s): contract numbers and contractor’s socioeconomic status.

3. Description of your company’s capabilities as they relate to the services described in this notice.

4. A description of your company’s previous experience providing the services described in this notice, including independent testing that substantiates your capabilities.

5. A description of any teaming/subcontracting your company anticipates utilizing in support of this requirement.

6. A statement indicating the ability of your company to meet the proposed period of performance (POP) OR a detailed explanation of what a feasible POP to complete this effort would look like.

7. A proposed method, timeline and cost estimate to complete the above-described research and development effort.

8. Any other relevant information that is not listed above which the Government should consider in finalizing its market research and acquisition strategy.