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This Pre-Solicitation opportunity from Department Of Health And Human Services was posted on July 28, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Clinical Laboratory Testing and Specialized Biochemical AnalysisServices for the NHGRI Undiagnosed Diseases Program (UDP) through Baylor Genetics Laboratory

Closed
75N98026Q00900Federal

Contract Overview

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AI Contract Overview

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The contract entails the provision of CLIA-certified clinical laboratory testing and specialized biochemical analysis services for the National Human Genome Research Institute’s Undiagnosed Diseases Program, under NIH protocol 15-HG-0130, through Baylor Genetics Laboratory. The work supports the evaluation of patients with complex, rare, and previously undiagnosed multisystem disorders, focusing on genetic, metabolic, and mitochondrial conditions. Services include advanced testing such as mitochondrial DNA copy number quantification, assessment of mitochondrial deletions, metabolomic profiling, biochemical pathway analysis, and testing of tissues including muscle, liver, fibroblasts, blood, and urine, along with follow-up family studies when authorized. All testing must adhere to federal and state regulations, using validated methodologies and maintained quality assurance systems to ensure accuracy and compliance. The contractor is required to deliver comprehensive laboratory reports with clinical interpretations and limitations within established turnaround times, using secure, privacy-compliant transmission methods. Immediate notification of critical or clinically significant findings is mandatory to support urgent patient care. Technical consultation services are essential, including guidance on test selection, specimen handling, result interpretation, and recommendations for additional testing. The contractor must also actively participate in scientific and clinical discussions as requested by NIH. The solicitation, numbered 75N98026Q00900, is issued by the National Institutes of Health within the Department of Health and Human Services, with responses due by August 7, 2026, and performance primarily based in Bethesda, Maryland.

General Info

CLIA-certified genomic and metabolic testing for undiagnosed diseases under NIH protocol, with rapid reporting and clinical consultation.

NAICS

621511 - Medical Laboratories

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

1

Clinical Laboratory Testing and Specialized Biochemical Analysis Services for NHGRI UDP

DOCX, High priority: read this firstrequirements
High

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Timeline

PhaseClosed
Posted

Presolicitation

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao
Contacts1 person available
OfficeBETHESDA, MD, 20892, USA
Office AddressBETHESDA, MD, 20892, USA
Contacts

Full Description

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Requirements:


Title Clinical Laboratory Testing and Specialized Biochemical Analysis Services for the NHGRI Undiagnosed Diseases Program (UDP) through Baylor Genetics Laboratory


1. Background The National Human Genome Research Institute (NHGRI) Undiagnosed Diseases Program (UDP) evaluates patients with complex, chronic, and previously undiagnosed medical conditions. Patients enrolled under NHGRI clinical protocol 15-HG-0130 typically have undergone extensive diagnostic evaluations prior to referral to the National Institutes of Health (NIH) Clinical Center and often present with multisystem disorders requiring advanced diagnostic testing. The UDP seeks to identify underlying disease etiologies, establish accurate diagnoses, and advance scientific understanding of rare and novel genetic conditions. Specialized laboratory testing is required to support diagnostic evaluations and ongoing research efforts associated with rare genetic disorders, mitochondrial diseases, inborn errors of metabolism, and other complex hereditary conditions. The Contractor shall provide Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory testing, interpretation, consultation, and reporting services to support the diagnostic and research objectives of the NHGRI UDP.


2. Objective The objective of this requirement is to obtain specialized clinical laboratory testing and expert interpretation services for UDP patients undergoing evaluation under NIH protocol 15-HG-0130. Services shall support the identification, characterization, and confirmation of rare genetic, metabolic, mitochondrial, and other complex disorders through advanced biochemical, molecular, and metabolomic testing methodologies.


3. Scope of Work The Contractor shall perform CLIA-certified laboratory testing and provide associated interpretive services for biological specimens submitted by the Government. Testing may include, but is not limited to: • Mitochondrial disease evaluations; • Quantitative PCR analysis for mitochondrial DNA copy number; • Assessment of mitochondrial DNA deletions; • Metabolomic analyses; • Biochemical pathway assessments; • Inborn errors of metabolism testing; • Muscle, liver, fibroblast, blood, urine, and other tissue-based analyses; and • Follow-up family studies, when authorized by the Government. The Contractor shall provide laboratory consultation and technical expertise as needed to support interpretation of findings and clinical decision-making. 4. Contractor Requirements The Contractor shall:


4.1 Laboratory Testing a. Perform CLIA-certified laboratory testing on submitted specimens in accordance with applicable federal, state, and accreditation requirements. b. Maintain all certifications, licenses, and quality assurance programs required to perform testing services. c. Conduct testing using validated methodologies and established laboratory procedures.


4.2 Reporting a. Provide written laboratory reports containing test results, interpretations, and any relevant limitations of testing. b. Issue reports within the established turnaround time (TAT) applicable to each test methodology. c. Notify the Government immediately of any critical or clinically significant findings requiring urgent medical attention. d. Provide reports through secure transmission methods compliant with applicable privacy and security regulations.


4.3 Consultation Services a. Provide technical consultation regarding test selection, specimen requirements, interpretation of findings, and follow-up testing recommendations. b. Participate in scientific and clinical discussions related to testing results when requested by the Government.

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