SAM_-_Pre-Solicitation__75N94025Q00202_R_1.pdf

75N94025Q00211

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT

OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), intends to award a purchase order without providing for full and open competition to HOLOGIC SALES AND SERVICE, LLC for Bioruptor Pico Sonication Device.

BACKGROUND

The mission of the National Institutes of Health (NIH) is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. As part of the NIH, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Intramural Research Program (IRP) conducts biomedical research and training related to diabetes mellitus; endocrine, bone, and metabolic diseases; digestive diseases, including liver diseases and nutritional disorders; and kidney, urologic, and hematologic diseases. The Laboratory of Biochemistry and Genetics is one of NIDDK IRP 17 Laboratories and Branches. The study of fundamental mechanisms of gene expression during development informs NIDDK’s basic understanding of organismal growth as well as disorders that result in chronic diseases such as those listed above. To advance work that aims to understand these fundamental mechanisms, the Laboratory of Biochemistry and Genetics needs equipment that will shear DNA, RNA, and chromatin; extract nucleic acid and protein; disrupt tissues, cells, and protein aggregates;

and solubilize compounds. The Laboratory of Biochemistry and Genetics is currently engaged in high-throughput genomic and epigenomic studies that require precise and reproducible sample preparation. A critical component of workflows involves the shearing of DNA, RNA, and chromatin to specific fragment sizes suitable for next-generation sequencing (NGS), chromatin immunoprecipitation sequencing (ChIP-seq), and other downstream applications. To achieve optimal results, it is essential to acquire and utilize a sonication device that offers consistent performance, scalability, and compatibility with low sample volumes.

JUSTIFICATION

The Bioruptor Pico sonication device by Diagenode is uniquely positioned to meet all of the NIDDK’s requirements. This all-in-one shearing system is optimized for processing micro-volumes ranging from 5 µl to 2 ml, accommodating a wide array of sample types, including DNA, RNA, and chromatin. Its ability to simultaneously sonicate 6 to 12 samples ensures high throughput capabilities, which is crucial for the lab’s large-scale studies. The device's advanced timing control and integrated cooling system provide precise temperature regulation, preserving sample integrity and ensuring reproducible fragmentation profiles.

Sample integrity and reproducible profiles are important for our studies. Bioruptor Pico's compatibility with various sample types, including formalin-fixed paraffin-embedded (FFPE) tissues and plant samples, enhances its versatility and applicability across different research projects. Its user-friendly design and robust performance have been validated through numerous peer-reviewed publications, underscoring its reliability in generating high-quality data.

Furthermore, Bioruptor devices use a unique system to uniformly process multiple samples simultaneously in sealed tubes

, without risk of sample cross-contamination or aerosol formation, significantly improving biosafety. Continuous sample rotation ensures equal energy distribution and consistent shearing, which benefits our research.

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

The requested bioruptor equipment does sonication, without the device, our lab will not be able to understand the interplay of DNA and RNA in genome organization, which is critical to the research mission of NIH and NIDDK because maintenance of genome organization is directly relevant to human health and the potential discovery of therapeutic approaches to treat diseases affecting the kidneys and liver. In summary, the Bioruptor Pico sonication device aligns with the laboratory's needs for efficient, reproducible, and scalable sample preparation. Investing in this technology will not only streamline workflows but also enhance the quality and consistency of our research outcomes. Diagenode, LLC, an entity under Hologic Sales and Service, LLC, is the original equipment manufacturer of the Bioruptor Pico Sonication Device, and is the only known source for the required equipment.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334516 Analytical Laboratory Instrument Manufacturing, size standard in number of employees 1,000

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2025-05 effective 08/07/2025. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12- Acquisition of Commercial Items.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of FAR 13.106(b)(1) Soliciting from a single source - For purchases not exceeding the simplified acquisition threshold.

PLACE OF DELIVERY

NIH/NIDDK

BLDG 50, RM 3133

50 South Drive Bethesda, MD, 20814

DESCRIPTION OF REQUIREMENT

Bioruptor Pico sonication device including Essential Starter Pack, one-year support package covering all manufacturing repairs, firmware updates, a quality control kit including a highquality tube holder, and a bonus pack of shearing consumables. 15 ml sonication accessories for Bioruptor, Tube holder its dock for 1.5 ml tubes, 15 ml Bioruptor Tubes & sonication beads, 0.65 ml microtubes, 1.5 ml Bioruptor Microtubes with Caps. Cuff Hose 2m

Delivery by 90 Days After Receipt of Order (ARO).

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability in response to this notice and may submit a capability statement, which shall be considered by the agency. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All respondents must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses to this notice shall be submitted electronically by 5:00 PM Eastern Standard Time, on September, 11th, 2025 to jacob.balenson@nih.gov and shall include pre-solicitation # 75N94025Q00211 in the subject line.