Notice of Intent to Sole Source MiSeq FGx Sequencing Systems

This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the Armed Forces Medical Examiner System (AFMES) to purchase, deliver, and install one MiSeq FGx Sequencing Systems and associated software as prescribed in FAR 13.106-1(b)(1). Specifically, the Government will procure this from Verogen, Inc.The Verogen Inc. MiSeq FGx Sequencing Systems is a Next Generation Sequencing (NGS) instrument that has previously been validated for use by the AFMES. The MiSeq FGx offers the ability to run the traditional data analysis software (MiSeq) as well as the new ForenSeq Universal Analysis Software. The ForenSeq Universal Software will allow Armed Forces DNA Identification Laboratory (AFDIL) to utilize the new forensically validated NGS kits from Illumina and/or Promega. The new NGS kits will allow for the analysis of autosomal Short Tandem Repeat (STR)’s, Y-Chromosome STRs, Identity SNPs and Ancestry Informative SNPs in a single assay. The

MiSeq FGx system will permit simultaneous access to nuclear DNA, mitochondrial DNA and Y-chromosomal DNA information.Verogen Inc. is the sole manufacturer and reseller of the Forensic MiSeq FGx Sequencing System listed in this document. AFMES-DNAOps is a forensic DNA testing laboratory that is accredited by the ANSI National Accreditation Board (ANAB) to the ISO-17025 and FBI-QAS standards for DNA Forensic Laboratories. Based on accreditation adherence (Volume III of the Quality Manual and the FBI's QAS document), all equipment and software must be developmentally validated by the manufacturer and internally validated by the laboratory to all reagents used for DNA testing as well as pass a stringent quality control before being released for casework. Furthermore, forensic accreditation standards say that manufactures who supply DNA forensic instruments and reagents must have established GLP/GMP process as well as being ISO 18385 Forensic DNA grade accredited. Verogen Inc. is ISO 18385 compliant.The MiSeq FGx Sequencing System’s platform accuracy and read time (turnaround time) are critical to the AFDIL in order to support the NDAA 2010, which stipulates that the past accounting community needs to build the capability to annually make 200 identifications as it is the only instrument. Three out of the existing seven MiSeq FGx sequencing systems utilized by AFMES-DNAOps in support of mission requirements have either reached or are exceeded End of Life-Cycle replacement and will need to be replaced with new MiSeq FGx sequencing systems based on the availability of funds. In 2013, AFMES-DNAOps started to develop an NGS whole genome mtDNA sequencing method for chemically treated samples. After 2 years of research and development the NGS mtDNA capture assay was developed and in accordance with the sequencing method, the MiSeq FGx system was compared against other commercial equivalents; was deemed optimal for use with chemically treated samples. The MiSeq FGx was then validated for use following accreditation standards, which took 12 months to perform. In 2016, the MiSeq FGx coupled with the NGS mtDNA capture assay was published and brought on-line for human remains testing. AFMES-DNAOps was the first and still only DNA forensic laboratory with the capability to process human remains that have been chemically treated. After 6 years, AFMES-DNAOps has 6 MiSeq FGx and has increased sample processing from 6 samples per month to 100 samples per month. The NGS method is used on samples from World War II, Korean War, Vietnam War, and the Cold War. This MiSeq FGx/NGS mtDNA capture assay has led to 175 new identifications that could not be accomplished using traditional forensic methods.This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. 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 at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source requirement.All questions and responses concerning this notice shall be emailed to James Cheng at james.cheng1.civ@mail.mil. Interested concerns must identify their capability in writing to the above email address listed above no later than 4:00 PM ET, 28 July 2022.