Proteomic Effects of Different Extreme Metabolic States

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 (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to SOMALOGIC, INC for services to study the proteomic effects of different extreme metabolic states. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.50. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2020-07 effective August 31, 2020. 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). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13'Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6'Competition Requirements. BACKGROUND The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology. NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities. The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts. PURPOSE AND OBJECTIVES Insulin resistance (IR) is frequently associated with liver disease since insulin signaling occurs in the liver to significantly affect carbohydrate and lipid metabolism. The issue is that biomarkers used to study IR and liver disease are often affected by both disease states, making it difficult to differentiate the effects of both conditions. By comparing levels of over 4,000 circulating proteins between patients with rare diseases of extreme insulin resistance and/or extreme liver disease, we hope to utilize NIH's unique patient cohorts to differentiate between these two disease states. Patients with lipodystrophy have both IR and liver disease, patients with insulin receptor mutations only have IR, and patients with hepatitis D virus infection only have liver disease. By understanding protein differences among these extreme disease states, we can not only better understand the pathophysiologic differences between IR and liver diseases but be able to identify biomarkers that can be applied to less severe diseases like general obesity to better understand whether their IR or liver function requires treatment. The goal of the current study is to compare 30 patients with lipodystrophy not being treated with metreleptin to 30 patients with insulin receptor mutations matched for age, sex, and glycemia using hemoglobin A1c at the time of sample collection, 17 other patients with lipodystrophy before, 2 days, and 2 weeks after metreleptin therapy while other medications and patient diet were controlled, and 8 healthy control samples for comparison. We hypothesize that, by comparing patients with extreme insulin resistance and/or extreme liver disease using NIH's cohorts of patients with rare disease, may reveal novel differences between the effects of insulin resistance and liver disease on levels of circulating proteins in the body. Separation, identification, and quantification of over 4,000 individual proteins in 118 samples of plasma from patients enrolled in an approved clinical trials on the vendor's patented platform: this will enable us to obtain a through sense of all circulating protein changes that occur in patients with lipodystrophy, insulin receptor mutations, and extreme liver disease. Specifically, the NIDDK requires the following tasks: TASK AREAS TASK AREA 1 - The NIDDK sends to send the patient samples to SomaLogic, Inc. before the service can be provided. TASK AREA 2 - Samples will be shipped on dry ice using standard shipment. The services provided by SomaLogic, Inc. can be provided remotely once the services are provided. TASK AREA 3 - Access to the study deliverables (Word report, Excel data file). SomaLogic, Inc. also provides data analysis and visualization tools that allow for further data exploration. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10'Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined SOMALOGIC, INC. to be the only reasonably available source to provide services to study the proteomic effects of different extreme metabolic states the NIDDK requires. SomaLogic is a world leader in the field of proteomics by pioneering and patenting the use of aptamers to measure the most extensive profile of proteins using small volumes of patient samples. There is no other vendor capable of measuring as many proteins as SomaLogic is now capable of measuring using limited quantities of patient samples. Thus, there is no other company that currently performs this service and provides the necessary support for analysis and interpretation. SomaLogic, Inc. is the sole source for the following reasons: - SomaLogic has the patented platform that is proprietary and only one capable of measuring and identifying over 4000 different proteins - SomaLogic has the proprietary software to analyze the results PERIOD OF PERFORMANCE Within 12 Months of Date of Award Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda MD 20814 CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. 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 responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Tuesday, September 15, 2020 to the Contract Specialist, Amber Harris, at contact@example.gov . Assessment of Capability Lowest Price Technically Acceptable