Notice of Intent to Sole Source: TwinStrand Duplex Sequencing Mutagenesis Kits

FDA Notice of Intent to Award Sole Source Notice ID:

75F40124Q122878 Title:

TwinStrand Duplex Sequencing Mutagenesis Kits Date Posted:

June 12, 2024 Response Date:

June 19, 2024, 1:00 PM CST Classification Code:

6640 – Laboratory Equipment and Supplies NAICS Code: 325414- Biological Product (except Diagnostic) Manufacturing; Small Business Size Standard is 1250 employees. The U.S. Food and Drug Administration (FDA) intends to award a firm fixed price purchase order to TwinStrand Biosciences, Inc., 3131 Elliott Ave, Suite 750 Seattle, WA 98121, under the authority of FAR 13.106-1(b)(1).

The National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology (DGMT) has a requirement for TwinStrand Duplex Sequencing Mutagenesis Kits to be used in an approved scientific study to assess mutations induced by nitrosamines as part of research to be conducted under NCTR Protocol E07796.01 titled as “Establishment of an in vivo mutation test pipeline for evaluating the mutagenicity of N-nitrosamines”.

This study requires DNA duplex sequencing (DS) as one of the methods for the in vivo test pipeline. DS is a form of error-corrected next-generation sequencing(ecNGS), which offers the advantage of measuring mutations in any tissue of animals at multiple genomic locations and has been shown to detect mutation induction comparable to TGR assays.

Duplex sequencing is a library preparation and analysis method for next-generation sequencing (NGS) platforms that employs random tagging of double-stranded DNA to detect mutations with higher accuracy and lower error rates. The kit includes required DNA index and library construction materials to target 20 genome targets with 2500 basepairs for each target. The assay can detect rare mutations with a frequency less than 1 mutation in 100 million basepairs.

One goal of the research under NCTR Protocol E07796.01 is evaluating if the assay can detect N-nitrosamine-induced mutations in tumor target tissues. Currently, only TwinStrand Biosciences, Inc. provides the duplex sequencing technology. Thus, it is the only source to provide the technology to complete the research. This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(1) requiring the dissemination of information on proposed contract actions.

This is a notice of intent to award a sole source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 13.106-1(b)(1). This notice of intent is not a request for competitive proposals. Responsible sources who believe they may submit a capability statement to Warren Dutter at warren.dutter@fda.hhs.gov on or before June 19, 2024 at 1:00 pm Central Time (CT).

A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted.