Genetic testing services for patients with rare and unknown neuromuscular disorder

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA) intends to award a sole source contract under the authority of Federal Acquisition Regulation (FAR) 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This contract will be awarded to The Broad Institute of MIT and Harvard, 75 Ames Street, Cambridge, MA 02142, to provide Genetic testing services for patients with rare and unknown neuromuscular disorder without providing for full or open competition.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS code 541714 - NA

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-06 dated May 1, 2022.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

The Broad Institute of MIT and Harvard and the Analytic and Translational Genetics Unit at Massachusetts General Hospital have extensive experience in using various genetic testing methodologies to accurately identify DNA variants affecting gene function using large-scale datasets containing genetic information from more than 90,000 human genomes. The Broad also studies transcriptome sequencing (RNA-seq) approaches to better understand the impact of variants on human gene function. The Broad leads an international consortium, gnomAD that has compiled the largest collection of sequences of the protein-coding region (exome) of the human genome. Combining these techniques whole exome sequencing (WES), RNA-sequencing and Whole Genome sequencing) have been proven to diagnose patients with rare neuromuscular disease as evident from high impact papers published based on the services provided.

The purpose of this contract is to provide genetic testing services to patients enrolled in our research study. Approximately 50% of patients remain undiagnosed after use of genetic testing tools.  The goal of the research is to obtain genetic diagnosis and identify novel genetic causes for muscle disease. Broad/MGH CMG will provide next generation-based sequencing services including: Whole exome sequencing, whole genome sequencing and RNA sequencing. Additionally, Broad will provide access to data through an analysis platform Seqr.

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. The Broad Institute has established proprietary sequencing processes to analyze samples and has developed Seqr, an open-source software platform for rare disease genomics. The proprietary processes and data platform can be utilized across a variety of studies for various disorders. NINDS requires application of the proprietary processes for a specific outcome for the NINDS protocol 12-N-0095 (“Protocol”). NINDS Protocol objective is to better understand nerve and muscle disorders that start early in life and run in families. The seqr platform contains a wealth of data that the NINDS will build on for its research to identify genetic causes of neuromuscular disease. Therefore, only The Broad Institute is capable of meeting the needs of this requirement.

The intended source is:

The Broad Institute of MIT and Harvard

75 Ames Street

Cambridge, MA 02142

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.

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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), 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.

All responses must be received by the closing date and time of this announcement and must reference 75N95022Q00435. Responses must be submitted electronically to Llakim Dubroff, Contract Specialist, at Llakim.Dubroff@nih.gov  U.S. Mail and Fax responses will not be accepted.