This Government Contract opportunity from Department Of Defense was posted on May 15, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Clinical Validation & Regulatory Strategy

Closed

Federal

Submission Closed05/22/2026, 07:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541690

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Solicitation # 140A0926Q0030

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Solicitation # 140A0926Q0033

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Navajo Region

POSTED

1 day ago

DEADLINE

in 4 days

AI Contract Overview

This contract involves conducting clinical and analytical validation studies using real-world human specimens. The primary objective is to develop a regulatory pathway for FDA submission, with a focus on establishing eligibility for a CLIA waiver. It is structured as a subcontract under NAICS code 541690 and is sponsored by the Department of Defense, specifically through the W6QK Acc-apg agency. The work will be performed in Frederick, with a submission response deadline set for May 22, 2026. The contract aims to bridge scientific validation with regulatory strategy, ensuring that the clinical data supports FDA approval and facilitates streamlined laboratory use under CLIA guidelines. This comprehensive approach is critical for advancing medical diagnostics or related technologies toward market readiness under federal oversight.

General Info

Conduct clinical validation using human specimens for FDA submission and CLIA waiver, DOD-sponsored, deadline May 2026.

Agency

Department Of Defense → W6QK Acc-apgView Agency

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Frederick, MD, USA

Set-Aside

NONE

Documents

This scope was carved out of W911SR-26-R-MNGS.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Agnostic Metagenomic Next-Generation Sequencing (mNGS) for Clinical Diagnostics

AI Contract Breakdown

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Timeline

PhaseClosed

PostedMay 15

subcontract

Response DeadlineMay 22

Deadline has passed

Submission Closed

05/22/2026, 07:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Defense → W6QK Acc-apg

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Defense → W6QK Acc-apg

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

Conduct clinical and analytical validation using real-world human specimens and develop a regulatory pathway for FDA submission including CLIA waiver eligibility strategy.