Epidemic Outbreak Surveillance

This is a Request for Information (RFI) only. This RFI shall not be construed as a formal solicitation or an obligation on the part of the government to acquire any product or services. It does not guarantee that a subsequent solicitation will be issued. Submission of any information in response to this RFI is completely voluntary, and costs associated with any submission shall not be reimbursed by the Government. The information requested will be used by the Air Force Medical Service (AFMS) to facilitate decision making. The Request for Information is issued without restrictions and is intended only to invite participation. It is not intended as an invitation for proposals. Purpose: The Epidemic Outbreak Surveillance (EOS) program addresses the need for a comprehensive diagnostic and informatics surveillance system, utilizing - state-of-the-art technology to identify both natural and hostile biological pathogens in near - real time to provide critical decision support to a wide and relevant audience. Scope and Mission: This announcement covers a systems technology which is a transformation dual use approach for operational medicine and biodefense, designed to rapidly detect and identify a wide range of pathogens. It is intended to overcome two diagnostic challenges to discriminate between diverse pathogens that present similar to flu-like symptoms; and screen rapidly, accurately and simultaneously across multiple 20-100+ candidate pathogens. This technology will use sophisticated, molecular biology procedures, bio-informatics, and connectivity to provide commanders at all levels the information needed to make time-critical decisions. Ultimately this situational awareness provides a high likelihood that correct diagnostic decision will be made, even prior to the onset of symptoms. Background: The importance of rapid detection of biological pathogens for both common and bio-warfare agents is well documented, embedded in several Joint Requirement documents, including CJCS Force Health Protection, Joint War fighting S&T Plan, 2003, and most recently the Department of Homeland Security PD 10 and 18. COCOMs need the ability to detect biological events/attacks in near real time to project (warn, treat, and respond) forward forces, garrisoned troops, and forces at embarkation, and debarkation. Performance Objectives: The offeror/contractor is requested to address in writing how the company's technology is capable of meeting the following provisions: a. The system must be able to perform up to 100 tests or detect 100 targets simultaneously on a single sample. b. The system must provide rapid results within 90 minutes from sample input to answer. c. The system must be able to test both clinical and environmental samples including: Nasal and throat swabs, Nasal aspirates, Blood, Stool, Urine, Wounds, Liquid and solid food samples, Vectors such as mosquitoes and ticks, Environmental swab samples, and Environmental powder samples. d. The processed sample must be contained across the analysis process and the system must integrate minimal contamination through the use of a closed, self-contained consumable to prevent amplicon decontamination and provide easy disposal of biohazard us material. e. The system must integrate the entire work flow with an intuitively easy-to-use and difficult to misuse systems concept from sample input to answer, including automated sample preparation, analysis and reporting. i. The sample preparation component can be a separate unit to accommodate different sample matrices to support optimal sample processing and extraction efficiency. ii. The system must be able to decontaminable. f. The system must have moderate to high sample throughput flexibility with the capacity to test at least 12 samples simultaneously at any given time. g. The system must have sample input flexibility with - Random Access capability to input and begin testing up to 12 different samples independently at any interval. h. The system must have integrated IT capability to track patient information and demographics to sample, including the ability to interface bi-directionally with a laboratory information system. i. The system must be able to generate test reports electronically in a standardized method with patient or sample information and the ability to transmit results electronically. j. The system must be robust and easily re-locatable without requiring realignment or calibration after moving. k. The system must be able to detect RNA and DNA organisms simultaneously from the same sample. l. The system must have nucleic acid detection sensitivity and specificity equivalent to real-time TaqMan PCR. m. The system must be a competitively priced with an inexpensive consumable. n. For those applications that meet the definition of an In-Vitro Diagnostic, the manufacturer must address their plans for FDA approval for the In-Vitro Diagnostic (IVD). (In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body." [21 CFR 809.3]) o. Ideally the system/platform will utilize FDA cleared technology for analytical measurement to facilitate In-Vitro diagnostic applications. p. The following capabilities of the test system are desirable but not mandatory: i. The system can be used to test for both nucleic acid (DNA and RNA) and protein agents simultaneously from the same sample consistent with the requirements above for nucleic acid testing. ii. Internal controls will be integrated into the consumable and will not require processing or input separately from the test sample. iii. Consumable reagents will be stable for 12 months at ambient temperature. iv. The system will be operable by a single technician. v. The system will have a footprint of < 15 ft2. The offeror's response needs to provide at a minimum, all areas in the criteria section above. The input will help Air Force ascertain the interest, capability, and capacity of all potential offerors. A review of North American Industrial Classification (NAICS) codes finds that NAICS 541711 (Research and Development in Biotechnology) has a size standard of 500 employees. Comments on NAIC code selection are welcome. If you are interested large or small business, please forward a talking paper, not more than two (2) pages in length together with candidate product information sheets for diagnostics and surveillance, not later than 28 30 April, 2008 to the following e-mail addresses: Maryam.Fatima.Ctr@Bolling.af.mil or Barry.Snyder@Bolling.af.mil. All submissions should be sent electronically, even if additional copies or fact sheets are mailed separately to: Mailing Address: 5201 Leesburg Pike, Suite 1501 Falls Church, VA 22041-3203