Notice of Intent to Sole Source for QuartStudia 7 Pro Real-time PCR System

Notice of Intent to Award a Sole Source Contract – FDA125578 The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to Life Technologies Corporation. In accordance with the authority under FAR 13.106-1(b)(1)(i), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source is reasonably available. NAICS code is 334516 - Analytical Laboratory Instrument Manufacturing. 1. Purpose The purpose of this requirement is to acquire one ( 1) QuantStudio™ 7 Pro real-time PCR System to upgrade the Applied BiosystemsTM 7500 Fast PCR system that Microbial Method and Development Branch (MMDB) uses to rapidly detect human pathogens in food or environmental samples. 2. Background MMDB in the Division of Microbiology develops, optimizes and validates rapid and highly sensitive microbiological and molecular methods and instrumentation used for recovery, detection, and quantification of enteric bacterial pathogens and their related toxins from foods and cosmetics as well as related food processing and farm production environments. Real-time PCR methods rely on the robust, sensitive, accurate and automated PCR system. MMDB has been using Applied BiosystemsTM 7500 Fast for their Real-time PCR method for the detection pathogens, including Salmonella , Shiga-toxin Escherichia coli and Listeria , according to the reference methods in the FDA Bacteriological Analytical Manual. Importantly Thermal Fisher will discontinue manufacture of Applied BiosystemsTM 7500 Fast DX Real-time PCR System in May 2022. There is no such timeline set for 7500 Fast system yet. However, with continually upgraded Applied BiosystemTM qPCR systems such as QuantStudio Family, we need to prepare for platform extension with new qPCR systems for our validated qPCR assays. The QuantStudio™ 7 Pro System has been optimized to enable the broadest range of quantitative PCR applications, with additional dyes, formats, and automation options. It increased application versatility through the accommodation of 4 different block types and maximized throughput capabilities. It improved well-to-well and instrument-to-instrument data accuracy achieved with the OptiFlex™ system, which features 6 decoupled excitation and emission filter channels with 21 filter combinations for maximum multiplexing and chemistry flexibility. It provides sensitive data analysis, which detects changes in target quantity as small as 1.5-fold in single-plex reactions and obtains 10 logs of linear dynamic range. This specific system is the only model that fits our needs for a multi-pathogenic screening equipment that is high throughput, robust, fast, and sensitive. 3. Objectives The objective is to acquire one ( 1) QuantStudio™ 7 Pro real-time PCR System to upgrade the Applied BiosystemsTM 7500 Fast PCR system. This notice is not a request for competitive quotes. Any other firms desiring consideration must fully identify their interest and capability of meeting the requirements by submitting a capability statement to Janice Heard at [email protected] no later than September 13, 2022. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government.