SOLICITATION NOTICE
A -- Film Array BioSurveillance BioFire Defense
- Notice Date
- 10/13/2017
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, U.S. Naval Medical Research Unit - 6 Peru, Unit 3230 Box 343, American Embassy, DPO AA 34031-0343, Lima, Non-U.S., 34031-0343, Peru
- ZIP Code
- 00000
- Solicitation Number
- N4485217RCP0018
- Archive Date
- 11/13/2017
- Point of Contact
- THOMAS HOOD, Phone: 301-619-9236
- E-Mail Address
-
thomas.l.hood26.civ@mail.mil
(thomas.l.hood26.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Award Number
- N6264517C4029
- Award Date
- 9/28/2017
- Description
- JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. This Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), Maryland, on behalf of the requesting activity, U.S. Naval Medical Research Unit Six (NAMRU-6), Virology & Emerging Infections Department, Lima, Peru. 2. Description of the Action Being Approved. NAMRU-6 has a requirement for the purchase of for the purchase of High Multiplex Polymerase Chain Reaction (PCR) instruments 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 proposed source is BioFire Defense, located at 79 W 4500 S, Suite 14, Salt Lake City, Utah 84107. 3. Description of Supplies/Services. The NAMRU-6 requirement is for High Multiplex Polymerase Chain Reaction (PCR) instruments 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 HKU1, Coronavirus NL63, Coronavirus 229E, Coronavirus OC43, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A/H1, Influenza A/H1-2009, Influenza A/H3, Influenza B, Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, and Respiratory Syncytial Virus, among viruses, and Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumonia among bacteria. The instrument must be FDA approved. 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 short period, which 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 4 hours to obtain a result. These delays can endanger participant's health; cause a loss of research participants to follow-up, as well as the 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. The estimated dollar value of the subsequent contract is $391,531.40 (unit cost of $39,761 per biofire kit).The type of funds expected to be utilized are FY 2017 Defense Health Program (DHP) Operations and Maintenance (O&M) funds. 4. Statutory Authority Permitting Other Than Full and Open Competition. 41 U.S.C. 1901(e)(2), (as implemented by FAR 13.501); Only one responsible source and no other supplies or services will satisfy agency requirements. 5. Rationale Justifying Use of Cited Statutory Authority. The BioFire Defense FilmArray BioSurveillance System is a High Multiplex PCR instrument that uses the FA Respiratory Panel (RP) (a multiplexed nucleic acid test) for the simultaneous qualitative detection and identification of multiple respiratory viral (17 viruses) and bacterial nucleic acids (3 bacteria) in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections. The unit is only one of two instruments that is FDA approved. This diagnostic platform is already deployed as a central part of multiple ongoing NAMRU-6 research studies at different locations throughout the Americas due to the platform having minimal requirements for trained personnel and lab infrastructure. Other platforms investigated by NAMRU-6 (including traditional PCR methods, Luminex MagPix, TAC-array cards, and MassTag-PCR) have advanced laboratory and personnel requirements that are impossible to project to austere research environments such as local clinics in developing countries. Furthermore, except for the Magpix, these units are not FDA approved. The Luminex MagPix is FDA-approved and detects all of the required pathogens, but it cannot be deployed to our research sites due to enhanced laboratory requirements and the need for highly trained lab personnel. NAMRU-6 has considered (and continues to investigate) other platforms (including lateral flow assays from ChemBio, SD Bioline) that are capable of deployment to such areas (including rapid tests by a number of other companies). First, these units are not FDA approved. Second, rapid tests from ChemBio and SD Bioline only detect 1 or 2 pathogen exposures, and suffer from poor performance in pathogen endemic environments such as our research sites). These have been found to have very low performance in terms of sensitivity and specificity as compared to the BioFire platform. The resulting false-positive and false-negative results from these other platforms could skew the data resulting from our investigations leading to erroneous interpretations of pathogen transmission risk to US personnel deployed to those theaters. The Nanosphere respiratory panel does not offer identification of important pathogens (i.e. Coronovirus and its subtypes, enterovirus, C. pneumoniae, and M. pneumoniae) required for our surveillance DOD program and is not FDA approved. The BioFire platform provides results by detecting amplified pathogen genomes in a nested assay (as compared to other rapid diagnostic assays reliance on: antibodies - which cross-react with other pathogen species, or: antigens that suffer from a much lower level of detectability than the nucleic acid detection used by BioFire). The Biofire platform requires less hands on time and allows the end user a shorter run time, the ability to be easily performed by non-skilled laboratory personnel (essential for field work and deployment settings) and FDA-approved tests. Furthermore the system saves time while reducing costs, because it simultaneously identifies 17 respiratory viruses and 3 respiratory bacteria within 1 hour. This enables rapid reporting of results to study-associated healthcare providers for better patient care, and reduces the time and cost needed for specimen shipment to central laboratories for advanced diagnostic testing. The BioFire Diagnostics FilmArray System from BioFire Diagnostics, LLC is the only system that possesses multiplex PCR technology in a single test format with a short (1-hour) turn- around time to final result with multiple targets tailored to each specimen type. No other system provides that is usable in these austere conditions provide testing for all of the required pathogens. 6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. This requirement will be synopsized via a Notice of Intent to Sole Source on Federal Business Opportunities (FEDBIZOPPS) for 15 days. Currently no other sources are being solicited, as Biofire Defense is the sole manufacturer and distributor for this equipment. If another company submits a written interest in this requirement as a result of the announcement, the company's information will be evaluated before the contract is signed with Biofire Defense. 7. Determination of Fair and Reasonable Cost. The Contracting Officer shall determine the anticipated cost to the Government of the supplies covered by the J&A to be fair and reasonable by conducting an appropriate price analysis. 8. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the type of supplies/services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible. If future requirements exist that do not involve the same research efforts, the Government will solicit through full and open competition to remove barriers.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/3c526433bf2a0aef21d828cdb430175d)
- Place of Performance
- Address: NAVAL MEDICAL RESEARCH UNIT SIX, NAMRU SIX, AV. VENEZUELA CDRA 36 S/N, BELLAVISTA - CALLAO, LIMA, Peru
- Record
- SN04713078-W 20171015/171013230741-3c526433bf2a0aef21d828cdb430175d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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