NOI001542 - TWIST Bioscience JA.pdf
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- Notice of Intent - Twist Bioscience
- Solicitation number
- NOI001542
About this file
This is a Justification and Approval (J&A) document for other than full and open competition prepared by the Federal Bureau of Investigation (FBI), Finance and Facilities Division, Procurement Section, National Acquisition Programs Unit (NAPU).
The FBI seeks to award a sole source, firm-fixed-price (FFP) contract to TWIST Bioscience Corporation (CAGE Code 6Z0F4), located at 681 Gateway Boulevard, South San Francisco, CA 94080, for a custom TWIST Bioscience assay panel on behalf of the Laboratory Division (LD), Biometrics Analysis Section (BAS), DNA Support Unit (DSU). The specific product required is a Twist Custom Panel with 96 Reactions (Part Number 101002; Twist Design ID: TE-91990771; Probes: 1256503). The contract is justified under 41 U.S.C. 3304(a)(1) and FAR 6.302-1, citing that TWIST is the sole manufacturer and sole distributor of this custom panel with no authorized resellers or third-party equivalents. The custom assay panel contains 1,256,503 probes and is critical to FBI Laboratory operations, supporting two primary mission areas: developing single-nucleotide polymorphism (SNP) profiles for Investigative Genetic Genealogy (IGG) investigations and performing DNA sequencing for information-investigation-intelligence (i3) casework. The FBI's contract laboratory, the National Bioforensic Analytical Center (NBFAC) in Fort Detrick, Maryland, has extensively tested and validated this assay. While competitors such as Illumina Inc. and Daicel Arbor Biosciences offer similar products, their offerings do not include the same required SNP markers and have not been tested or validated by the FBI Laboratory, making alternative sourcing impractical due to substantial additional costs and implementation delays. The FBI will post a Notice of Intent (NOI) on SAM.gov to provide other vendors an opportunity to demonstrate capability prior to award. The Contracting Officer will perform a price reasonableness determination in accordance with FAR 13.106-3 and 13.501(a)(2)(i) before contract award. Market research was conducted by DSU personnel and confirmed TWIST Bioscience as the only responsible source capable of providing this specific custom assay panel. The requisition number is SHOP-PR-26-001542, dated 04/06/2026. The FBI intends to continue conducting market surveys through industry publications to identify potential sources for subsequent acquisitions.
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Presently, BAS/DSU is performing testing and validation of IGG laboratory processes and will also continue to conduct i3 testing. The type of assay panel required for these purposes is best supported by a new contract action. The government purchasing card (GPC) substantially limits the threshold of reagents that can be procured at one time. As a result, GPC restrictions limit the efficiency and speed at which these sequencing tasks may be performed. This custom panel is critical to laboratory operations as IGG is one of the Laboratory Division's (LD) fiscal year (FY) 2026 priorities per the LD Assistant Director (AD). Without this assay panel, the BAS cannot meet this AD requirement.
The TWIST Bioscience assay has already been extensively tested and assessed by the FBI Laboratory's contract lab, the National Bioforensic Analytical Center (NBFAC) in Fort Detrick, Maryland, and has been shown to be fit for this purpose. This assay is a custom product, produced only by TWIST. Though other vendors such as lllumina Inc. and Daicel Arbor Biosciences may offer similar products, these products do not include the same set of required SNP markers and have not been tested/validated by the FBI Laboratory or FBI Laboratory contract labs. As a result, development and implementation of a different assay would necessitate extensive testing and evaluation, ultimately resulting in substantial additional costs (testing/evaluation/personnel) and unnecessary implementation delays.
4. The statutory authority permitting other than full and open competition.
For purposes of this acquisition, the statutory authority permitting other than full and open competition is delineated at 41 U.S.C. 3304 (a) (1) and implemented at FAR 6.302-1, "Only One Responsible Source and
No Other Supplies or Services Will Satisfy Agency Requirements'�
5. Demonstrate the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.
TWIST Bioscience Corporation is the sole manufacturer and the sole distributor of this custom panel for this requirement. There are no authorized resellers.
• Twist Custom Panel, 96 Reactions; Twist Custom Panel, 96 Reactions (101002)
Twist Design ID: TE-91990771; Reactions: 96; Probes: 1256503, Part Number: 101002
These items are commercially available supplies and products. Reagents and consumables are products widely used by numerous forensic laboratories in the United States. While these are commercial products, these items are very specific to the laboratory instruments they are being used on.
It is imperative that the FBI Laboratory obtain this custom reagent for the continued development of the
Investigative Genetic Genealogy workflow and to properly and efficiently process and analyze DNA samples submitted to the FBI Laboratory.
6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.
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