Custom Gene Fragments and Cloning Services by Twist Biosciences

PRE-SOLICITATION NOTICE **NOTICE OF INTENT TO SOLE SOURCE NOI-NIAID-24-2228309 NAICS – 541380, Testing Services This is a Notice of Intent, not a request for proposal.

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Twist Biosciences Corporation of San Francisco, CA to procure custom gene fragments and cloning services as required by the Cell Biology Section (CBS) in the Laboratory of Viral Diseases (LVD).

The Cell Biology Section (CBS) in the Laboratory of Viral Diseases (LVD) carries out investigations into the molecular biology of viruses, the interactions of viruses with host cells, the pathogenesis of viral diseases, and host defense mechanisms. The CBS has been very active in discovery of the mechanisms influenza uses to evade the immune system. These studies are designed to increase fundamental knowledge and facilitate the development of new approaches to the prevention and treatment of disease.

The goals of CBS are to determine the mechanisms used by viruses and tumors to evade the host immune response. COVID-19 is a worldwide pandemic of great concern. The CBS investigates these viruses by having parts of them, as well as antibodies against them, cloned into plasmids in order to rescue the virus and to express various components of the viruses in cell culture to identify the functions of genes and mechanisms of immunity.

These extractions and cloning services include gene fragments up to 1.8kb or clonal genes up to 5kb cloned into the plasmid vector of our choice. Only recently have companies formed that can create long DNA fragments and even clone the DNA fragments into plasmids, saving NIH time and expense. These techniques often use chemical gene synthesis, which is not something the lab is able to do themselves.

Although commercially available DNA fragments have been around for a while, custom genes have only been available for the past ten or so years. However, even these have been limited in size. Currently, commercial sources of DNA are limited to approximately 3,000 base pairs in length. The CBS has researched the issue and found that Twist Biosciences is the only company that will synthesize DNA sequences of up to 5,000 base pairs and clone them into a plasmid of requirements with unmatched speed.

Other vendors have been utilized but were deemed unsuitable due to price, quality and/or time to delivery. Twist Biosciences can create DNA fragments as specifically required for NIH/NIAID matching the gene complexity. The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.

All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-22-2228309) to Dana Monroe at dana.monroe@nih.gov, by 5:00pm ET, Tuesday, July 2, 2024. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.