Other Transaction Authority (OTA) Interest for Advanced Development, Procurement, Fielding, and Sustainment of a Lightweight, Low Complexity, Multiplex In Vitro Diagnostic Capability

NOTICE TYPE: Sources Sought SYNOPSIS: The purpose of this Request for Information (RFI) is to conduct Market Research for the advanced development, procurement, fielding, and sustainment of a lightweight, low complexity, multiplex in vitro diagnostic (IVD) capability. This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201e. This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Non-traditional defense contractors are encouraged to respond, as are contractors who are interested in entering into agreements with the Department of Defense (DoD) utilizing Other Transaction Authority (OTA) under Section 815 of the National Defense Authorization Act (NDAA) of 2016. OTAs are "used to carry out prototype projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be carried out by the DoD, or to the improvement of platforms, systems, components, or materials in use by the armed forces." Respondents are invited to provide information related to their capabilities to fulfill the requirements listed below. Respondents should provide whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. If candidates are interested in teaming with other sources, please include in your response authorization to release your company's name, area of interest, and POC information to be made available on a public website. All proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. BACKGROUND: The Medical Countermeasure Systems (MCS) Joint Project Management office leads the effort to develop and acquire safe, effective, and innovative medical solutions and systems to combat chemical, biological, radiological, and nuclear (CBRN) threats and emerging infectious diseases and to protect and preserve the lives of our operating forces. The MCS Diagnostics (Dx) mission is to develop, acquire, integrate, and field identification technologies and U.S. Food and Drug Administration (FDA)-cleared diagnostic devices intended for Service Members to aid in the early diagnosis, prevention, and treatment of the effects of exposure to chemical, biological, and radiological (CBR) agents. REQUIREMENT: The IVD capability will be used to diagnose pathogenic diseases including federal select agent pathogens ()regional endemic infectious diseases in syndromic assay panels and provide future diagnostic capabilities that enhance point-of-care (PoC) diagnosis of diseases of operational concern to the U.S. military. The IVD device should: 1. Be able to meet FDA regulatory requirements for in vitro diagnostic use for a relevant multiplex infectious disease panel by August 2019 2. Perform identification of DNA and RNA analytes from clinical matrices containing etiological agents 3. Provide an automated sample-to-answer capability (no manual sample preparation methods required once sample is taken from patient) within 70 minutes of initiating the diagnostic process 4. Be compatible with minimally invasive, easily accessible clinical sample types (e.g. fresh whole blood, urine, stool, saliva and nasopharyngeal swabs) and clinical sample collection techniques appropriate for use in austere environments (e.g. finger stick blood samples) 5. Operational suitability for use in austere, ambient environments: a. Easily portable: Weigh less than 7 lbs. and <300 cubic inches (including battery but without assay consumables) b. Operational Environment i. Wide operational temperature range for analyses ii. Reliable operation in dirty environments iii. Low light / day light readable screens / controls iv. Room temperature stable consumables for at least 1 year v. Resistant to shock and vibration while being transported (non-operating) c. Battery operable for at least 2 analyses d. Instrument, assay, and analytical protocol design capable of achieving a CLIA-Waived designation (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm393229.htm) e. Rapid set up / start up after movement (minutes) f. No calibration required g. Tool-less maintenance (no operator maintenance preferred) Responders are encouraged to address: 1. Specific capabilities to develop and obtain FDA clearance of hemorrhagic fever and syndromic febrile illness IVD assay panels 2. Other commercial off the shelf (COTS) assays (in development or currently available) that would contribute to DoD routine healthcare capability 3. Their internal quality system as it relates to FDA compliant commercialization of diagnostic devices for the US domestic healthcare market and include the regulatory maturity of their product and predicate devices, if any. PURPOSE AND OBJECTIVES: The primary objective of issuing this RFI is to seek information and comments from companies with experience and the capability to develop, manufacture and produce a point of care IVD that addresses DoD diseases of interest. As such, the Government has interest and is researching information about current industry capabilities via responses to the areas listed below: a. A company's experience in developing and delivering portable diagnostic capabilities for use in settings outside of a traditional hospital laboratory environment. b. Experience with the regulatory approval process, including providing capabilities under Emergency Use. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Questions regarding this RFI should be forwarded to the point of contact e-mail address listed below within 5 days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received no later than 30 Dec 2016. Submissions shall be electronic only and: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to the Point of Contact email below; (3) be minimum 11 font and printable on 8.5 X 11 paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 10 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to ATTN: Jessica Ely at the Contracting Office address identified below. Material that is advertisement only in nature is not desired. Contracting Office Address: Army Contracting Command, Aberdeen Proving Ground, Natick Division 1564 Freedman Drive, Fort Detrick, MD 21702 Point of Contact(s): contact@example.gov