Inactive

This announcement is to provide notice that the U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, on behalf of the Joint Program Executive Office for Chemical, Biolog... This announcement is to provide notice that the U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, on behalf of the Joint Program Executive Office for Chemical, Biological, Radioactive and Nuclear Defense (JPEO-CBRND) is seeking companies capable of providing commercial off-the-shelf (COTS) point-of-care diagnostic systems needing no hands-on sample preparation and a Minimum Technology Readiness Level (TRL) for the system (all components) at TRL-7. The TRL definitions can be found in the Government Accountability Office’s Technology Readiness Assessment Guide at https://www.gao.gov/assets/680/679006.pdf. The Government is seeking information on systems that have the following performance characteristics: Devices and assays that have been submitted for Food and Drug Administration (FDA) review, with Emergency Use Authorization (EUA), or already have 510k clearance (https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (i.e., virus, viral ribonucleic acid, or viral antigens) in respiratory specimens. Are hand held devices Suitable for use in FDA Clinical Laboratory Improvement Amendments (CLIA)-waived settings. Produce results in less than 60 minutes from obtaining sample. While this notice is not a request for competitive proposals, parties purporting to have the requisite capabilities to provide the systems and assays must furnish, in writing, factual information for the following points: 1) Product or system data sheets describing the function, size of the overall system and required components. Specifically the documentation shall provide evidence of the test result timeframe, the size and directions for use of the system. 2) Evidence of either FDA 501K approval or FDA EUA for the device and assays. 3) Information on system and assay pricing. Pricing information shall include evidence of commercially offered prices as well as provide information on available discounts to the Government. 4) Information on product availability from receipt of a Purchase Order and if the systems and necessary components are available for purchase via a General Services Administration (GSA) contract or any other Government contract instrument. Information must be sent, via email to Susan Ruzicka at susan.e.ruzicka2.civ@mail.mil no later than the time and date included in this announcement. All questions regarding this notice must be in writing only and received by 30 July 2020; no telephonic replies will be accepted.