NOI_Biofire_PCR_NAMRU-6.doc

The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR Part 13.501(a), Sole Source (including brand name) acquisitions, to Biofire Defense for two (2) v2.0 multiplex polymerase chain reaction (PCR) systems, two (2) hard sided cases, and supporting supplies that can support the detection and identification of multiple respiratory and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The following organisms and subtypes must be able to be detected and identified using the required instrument: Adenovirus; Coronavirus 229E; Coronavirus HKUl; Coronavirus OC43; Coronavirus NL63; Human Metapneumovirus; Human Rhinovirus/Enterovirus; Influenza A; Influenza A/HI; Influenza A/HI Influenza A/H3; Influenza B; Para influenza l; Parainfluenza 2; Parainfluenza 3; Parainfluenza 4; and 3 Bacterial pathogens with 99% accuracy: Bordetella.

The systems shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even though delivery is requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even though delivery is requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

The instrument must be able to integrate sample preparation, amplification, detection and analysis for 20 or more pathogens simultaneously, into one system that is simple to operate and can complete the entire process in a one-hour period. This enables research physicians to present participants with results and proceed immediately with additional study components and provide mission-critical, real-time, surveillance data for the U.S. DoD and its partners to respond effectively and in a timely manner to protect the health of military forces in deployed areas and to address international public health issues and threats. Traditional methods of PCR can only be performed at advanced facilities with highly skilled and educated technologists, and is labor intensive utilizing a minimum of four hours to obtain a result. These delays can endanger the participant’s health, cause a loss of research participants to follow-up and can cause a loss of associated mission-critical data. Protocol NAMRU.2010.0010 specifically requires that samples collected in the morning to be processed and if positive, follow-up teams are to be deployed during the afternoon to obtain the subsequent data and samples. This protocol and others at NAMRU-6 form a mission-critical, real-time, surveillance data source for the US DoD and its partners to protect health.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the system shall be in accordance with the OEM terms and conditions.

If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of Part 13.501(a) to Biofire Defense, 79 West 4500 South, Suite 14, Salt Lake City, UT, 84107.

This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 1 (8.5 x 11 inch) page using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.

Capability statements are due by 1:00 Eastern Time, 16 June 2018. Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to the following address: marciano.a.diaz.civ@mail.mil AND roger.k.batchelor2.civ@mail.mil. No phone calls will be accepted.