Notice of Intent to Sole Source_Promega Corporation

THIS IS A NOTICE OF INTENT TO AWARD A SOLE-SOURCE CONTRACT

AND IS NOT A REQUEST FOR COMPETITIVE PROPOSALS.

The United Stated Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis, IAW FAR 13.5, with Promega Corporation, 2800 Woods Hollow Road, Madison, WI 53711-5300 ,as the only responsible source that can provide customized forensic reagents and consumables for the identification of fallen U.S. service members.  This acquisition is being conducted under FAR Part 12 Acquisition of Commercial Items. Provisions and clauses in effect through Federal Acquisition Circular are incorporated.

The requiring activity for this action is the Defense Health Agency (DHA), Armed Forces Medical Examiner System (AFMES) requests a firm fixed price 5-year Blanket Purchase Agreement (BPA) for the purchase of customized Reagents and Consumables manufactured by Promega Corporation.

These reagents and supplies have been designed, previously optimized, and validated specifically for forensic laboratories, including equipment-specific for the various procedures of DNA identification.  The reagents have been tested and are compatible for use with: Life Technologies Genetic Analyzers Model 3500xl, Model 3730, and DNA thermocyclers Model 9700 and ProFlex; Promega Maxwell 16 Robotic platform; Beckman Coulter Biomek® FX robotic platform laboratory automation workstation;and Hamilton Robotics® STAR Line automated liquid handling workstations. The manufactures of the instruments above with regards to DNA Forensic testing provided a list of reagents that were developmentally validated for use on their instruments. Based on the compatibility of these reagents, AFMES DNA Operations following the Federal Bureau Investigations – Quality Assurance Standards (FBI-QAS) and ISO-17025 DNA Forensic accreditation standards validated all the reagents and supplies listed below for use with these instruments.  The FBI-QAS and ISO-17025 accreditation standard require a forensic laboratory to validate the platform, which consists of the reagents and instruments used to generate a DNA results. Competitor’s reagents although compatible with these instruments have not been validated by AFMES DoD DNA ops, and a new platform validation would take 9-12 months to perform at a significant cost to the government (see below).

Reagents Required under this BPA

Maxwell ® FSC DNA IQTM Casework Kit

The Maxwell® FSC DNA IQ™ Casework Kit is designed for optimal DNA extraction from forensic casework samples and uses a plastic cartridge and newly designed plunger that allow DNA elution in a final volume of no more than 50μl. DNA IQ™ Lysis Buffer, Resin and Wash Buffer are included in the prefilled cartridge, and DNA IQ™ Elution Buffer is included in the kit to ensure proper storage of the DNA. The Maxwell® FSC DNA IQ™ Casework Kit is compatible with the Maxwell® FSC Instrument and Maxwell® RSC 48 Instrument.

DNA IQ™ System – 400 reaction (rxn)

The DNA IQ™ DNA purification system lyses DNA containing cells in the presence of Dithiothreitol and Proteinase K; purifies DNA using a paramagnetic bead resin to remove DNA Polymerase-Chain-Reaction (PCR) inhibitors and contaminants; and delivers a consistent amount of purified DNA from a variety of forensic DNA sample types (i.e. stains and liquid samples, buccal swabs, and blood stains on FTA® or other blood cards).

Tissue and Hair Extraction Kit

The Tissue and Hair Extraction Kit has been optimized to extract samples having higher protein content (i.e. hair and tissue) by using an extraction buffer that uses Proteinase K to lyse samples. The crude DNA extract from these samples is purified using the DNA IQ™ System.

Lysis Buffer – 150 ml

A lysis buffer solution developed solely for use with the Promega DNA IQ™ Systems for efficient lysis of DNA containing cells.

DTT (DL-Dithiothreitol), Molecular Grade

DTT is a strong reducing agent that is included in both the DNA IQ™ and the Tissue and Hair extraction kits is an essential DNA extraction buffer component.

1.2 ml Round Bottom Deep Well Plate, 96 well format – 50/pack

Promega 1.2 mL round bottom plates were developmentally validated for use with the DNA IQ™ System on automated DNA extraction platforms.

Plexor® HY System – 200 and 800 rxn format

The Plexor® qPCR and qRT-PCR Systems are multiplex-capable real-time amplification systems using novel base pair chemistry. The Plexor® Systems work by measuring a reduction in fluorescent signal during amplification.

Plexor® Calibration Kit, set A

A calibration kit required for the proper use of the Promega Plexor® HY System on the Applied Biosystems 7500 real-time PCR system.

The PowerPlex® fusion System (200rxn, 800rxn, and custom kit size)

A 24-locus multiplex for forensic human identification applications that allows for the co-amplification of the following loci CSF1PO, FGA, TH01, TPOX, vWA, D3S1358, D5S818, D7S820, D8S1179, D13S317, D16S539, D18S51 and D21S11, D10S1248, D22S1045, D2S441, D1S1656 and D12S391, Amelogenin, DYS391,Penta D, Penta E, D2S1338 and D19S433. This extended panel of STR markers is intended to satisfy both U.S and European Forensic recommendations.

PowerPlex® 5-Dye Matrix Standards

This Matrix Standard is required for the Promega brand PowerPlex® and Fusion Systems to be properly analyzed on the Life Technologies 3130xl and 3500xl Genetic Analyzer.

WEN Internal Lane Standard 500, 5 preps

Defined Internal Lane Standard (ILS) fragments used with the PowerPlex Fusion kits that are analyzed on the Applied Biosystems 3500 xl Genetic Analyzers.  ILS fragments increase in size by 20-25 base pairs from 70 bp -500 bp.

2800M Control DNA, custom kit

An alternate positive control DNA for the Promega brand PowerPlex® Systems.  This control DNA allows for the use of only one control DNA for both autosomal and Y-STR analyses types of analyses.

K562 DNA High Molecular Weight, 30ug

Purified Human Chronic Myelogenous Leukemia cell line DNA that is used as a certified DNA reference for the quality control of STR kits.

Tween (R) 20, 500 ml

Tween® 20, Molecular Biology Grade, is a nonionic detergent used for many different molecular biology applications within the AFMES DNA forensic laboratory.

Proteinase K (PK) Solution, 4 ml

Proteinase K is a serine protease that exhibits broad cleavage activity. It cleaves peptide bonds adjacent to the carboxylic group of aliphatic and aromatic amino acids and is useful for general digestion of protein in biological samples. It has been purified to remove RNase and DNase activities. The stability of Proteinase K in urea and SDS and its ability to digest native proteins make it useful for a variety of Forensic DNA extraction methods. 

The intended procurement will be classified under North American Industry Classification System (NAICS) 334516 with a Small Business Size Standard of 100 employees. This notice of intent is not a request for competitive proposals and no solicitation document will be posted for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government. 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 normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Submit email capabilities statements (using PDF, MS Word, Excel attachments) to Kasey Carroll at kasey.l.carroll.civ@health.mil. Statements are due no later than 10:00 A.M. EST on 12 June 2025. Late responses will not be reviewed.