Abbott Molecular Inc. M2000sp/rt System

This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of Walter Reed Army Institute of Research (WRAIR), Military HIV Research Program (MHRP), Department of Laboratory Diagnostics and monitoring (DLDM) to purchase the medical diagnostics research system detailed below on a sole source basis from the Original Equipment Manufacturer (OEM), Abbott Molecular Diagnostics, Inc. 1350 E. Touhy Avenue, Des Plaines, IL 60118-3315 as prescribed in FAR 13.106-1(b)(1)(i). The Government will purchase Abbott M2000RT System, and m2000sp Instrument E-series, which is needed to further support malaria diagnostics for malaria clinical vaccine trials and Military Treatment Facilities (MTFs). The Abbott M2000 sp/rt System has been validated for the molecular diagnostic assay by Dr. Murphy, University of Washington, Seattle, Washington, and is pending clearance by the Food and Drug Administration as a 510K Laboratory Developed Test (LDT). The purchase of Abbott M2000 sp/rt System is required to continue the Plasmodium pan (genus) 18S RNA qPCR assay research and validation studies by Dr. Murphy to complete the College of American Pathologist (CAP) validated malaria molecular diagnostic assay. Procurement of any other instrument would invalidate all research efforts, delay implementation of CAP and therefore, FDA clearance. Product Number/ Product Description/ Quantity 09K 15-001/ M2000RT Instrument System/ 1 09K 14-002/ M2000sp Instrument E-series/ 1 The North American Industry Classification System (NAICS) for this requirement is 339112 and the size standard is 1,000 employees. These items are needed at Walter Reed Army Institute of Research, Silver Spring, MD. Based on the initial market research completed by the Government, the manufacturer is the sole manufacturer, distributer, and service provider of the specific parts listed above, which are needed for further support of malaria diagnostics for malaria clinical vaccine trials and Military Treatment Facilities (MTFs). This announcement fulfills the synopsis requirements under 5.201 (a) and 5.203(a). This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects fifteen (15) days after the publication of this notice, the Government intends to issue an award directly to Abbott Molecular Inc. All questions and responses concerning this notice shall be emailed to Ms. Jessica L. Wright at jessica.l.wright106.civ@mail.mil Interested concerns must identify their capability in writing to the above e-mail.