Regulatory Support for Software As Medical Device (SaMD) For Next-Gen Sequencing ID Analysis
Past New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Points of contact
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The National Institutes of Health plans a new requirement for regulatory support for Software as a Medical Device (SaMD) for next-generation sequencing identification analysis, with an estimated solicitation release date of May 1, 2026 and an estimated award date of July 1, 2026. Qualified contractors would review premarket submission documents that BugSeq developed before submitting to the FDA, advise on appropriate validation studies, and identify regulatory requirements for a successful FDA submission. The source describes BugSeq's software as applying AI algorithms to next-generation sequencing data to generate bacterial identification results that guide clinicians in determining infection type, and it characterizes approval of this task order as critical to BugSeq's FDA submission timeline.
The estimated award value range is $250,000 to $700,000, with no set-aside used and NAICS code 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Points of contact are Ignacio Reyes, Contracting Officer, at ignacio.reyes@nih.gov or +1 301-435-7574, and Lily Martin at lily.martin@nih.gov, both with the National Institutes of Health.
Forecast text
BugSeq is developing a software program that takes in next-generation sequencing data provided by the user, and applies AI algorithms to generate bacterial identification results to guide clinicians in determining the type of infection. BugSeq is looking for assistance through our qualified contractors to review the premarket submission documents that they developed before submitting to FDA. They also are seeking guidance on appropriate validation studies and any regulatory requirements needed for successful FDA submission. Approval of this Task Order is critical to meet BugSeq's timelines for FDA submission. The NIH team believes that this company's product is critical to the public health mission space by advancing in the use of next-generation sequencing for infectious disease diagnostic. More importantly, it could be the first device to receive FDA clearance for next-generation sequencing to detect a wide variety of pathogens and thus establish a new medical diagnostic category. This small investment will enable BugSeq to have the success needed to go through regulatory approvals and towards offering an actual commercial product that can be used for protecting public health. Any further delays would mean BugSeq will not be able to complete their validation studies in time for their planned FDA submission, and this could potentially impact the availability of the diagnostic for public health needs.
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