Opportunity Information: Apply for RFA HG 15 039

  • The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Novel Nucleic Acid Sequencing Technology Development - Direct to Phase II (R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172,.
  • This funding opportunity was created on Oct 27, 2015 and posted on Oct 27, 2015.
  • Applicants must submit their applications by Aug 07, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses.
Apply for RFA HG 15 039

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Opportunity Summary:

The grant opportunity titled "Novel Nucleic Acid Sequencing Technology Development - Direct to Phase II (R44)" is a Small Business Innovation Research (SBIR) funding announcement from the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services (HHS). Its core purpose is to fund small businesses that are ready to move directly into Phase II development of breakthrough nucleic acid sequencing technologies, with a particular emphasis on approaches that can enable genuinely new ways to sequence DNA and, importantly, direct RNA (meaning RNA can be sequenced without first converting it into cDNA).

This is a Direct to Phase II R44 opportunity, which generally signals that applicants are expected to already have convincing preliminary results or a strong technical foundation that would normally have been established in a Phase I feasibility study. In other words, the program is looking for teams that can credibly propose a substantial development plan, not just an early concept. The FOA is designed to support technology development that moves beyond incremental tweaks and instead targets major advances in capability, performance, or architecture. A key theme is encouraging applicants to step outside mainstream sequencing approaches and explore methods that are not currently dominant in the field.

The scope is intentionally broad in terms of what can be proposed, as long as the outcome advances sequencing technology in a meaningful way. Applicants may propose end-to-end sequencing systems, meaning a full platform that could include sample handling, chemistry, detection, signal processing, basecalling, and data analysis as an integrated workflow. Alternatively, they may focus on critical components of a novel system where there are specific bottlenecks or unresolved technical challenges, such as new detection modalities, improved enzymes or molecular interactions, novel nanopore or single-molecule configurations, new surface chemistries, microfluidic approaches, signal amplification strategies, or computational methods required to interpret new types of raw data. The FOA also allows proposals that improve existing sequencing systems, but it sets a high bar by calling for at least an order of magnitude improvement, which implies roughly a 10x gain in a key metric such as accuracy, read length, throughput, speed, cost per base, input requirements, direct RNA performance, or another clearly justified parameter that changes what is practically possible.

A notable element of the announcement is its explicit encouragement of high-risk, high-payoff projects. That framing is important because it suggests reviewers are meant to value ambitious technical leaps even when the path includes uncertainty, provided the application lays out a rigorous plan, credible milestones, and a compelling rationale for why the approach could transform sequencing. The emphasis on "methods other than those currently in use" reinforces that the program is not primarily aiming to fund routine evolutionary improvements to established chemistries or hardware, but rather to catalyze new classes of sequencing technologies or major departures from the status quo.

From an administrative standpoint, the opportunity is categorized as a discretionary grant with activity focused on health, reflecting NIH's mission and the central role sequencing plays in biomedical research and, increasingly, clinical applications. The eligible applicants are small businesses, consistent with SBIR requirements. The funding opportunity number is RFA HG 15 039, and it is associated with CFDA numbers 93.172 (and also listed with 93.172 in the provided data), indicating the NIH program area tied to genomics and related research support. The FOA was created and posted on October 27, 2015, with an original and current closing date of August 7, 2016. The provided listing does not specify an award ceiling or the expected number of awards, which usually means applicants would need to consult the full FOA text for budget guidance, project period expectations, and any institute-specific constraints.

In practical terms, this FOA is best understood as an NIH solicitation for small companies that are positioned to build the next major leap in sequencing, including direct RNA sequencing, by developing either complete next-generation platforms or the enabling components that would make such platforms viable. The strongest fit is a proposal that clearly articulates what "new approach" it unlocks, why that approach matters, what technical barriers stand in the way, and how the Phase II work plan will methodically reduce risk while pursuing a potentially transformative payoff.

Frequently Asked Questions (FAQs)

What is the name of this grant opportunity?

The opportunity is titled "Novel Nucleic Acid Sequencing Technology Development - Direct to Phase II (R44)."

Which agency is offering this funding opportunity?

This is a Small Business Innovation Research (SBIR) funding announcement from the National Institutes of Health (NIH), within the U.S. Department of Health and Human Services (HHS).

What type of award is this?

It is a discretionary grant. The activity focus is health, which aligns with NIH's mission and the role sequencing plays in biomedical research and clinical applications.

What does "Direct to Phase II (R44)" mean in this context?

"Direct to Phase II" generally indicates applicants are expected to already have convincing preliminary results or a strong technical foundation that would typically be demonstrated during a Phase I feasibility study. The program is looking for teams ready to propose a substantial Phase II development plan rather than an early-stage concept.

Who is eligible to apply?

Eligible applicants are small businesses, consistent with SBIR requirements.

What is the main purpose of the FOA?

The core purpose is to support small businesses developing breakthrough nucleic acid sequencing technologies, with emphasis on approaches that enable genuinely new ways to sequence DNA and especially direct RNA (sequencing RNA without converting it into cDNA first).

Is direct RNA sequencing specifically encouraged?

Yes. A key emphasis is on technologies that can sequence direct RNA, meaning RNA can be read without first being converted into cDNA.

What kinds of projects are considered a strong fit?

Strong-fit projects credibly propose a Phase II development plan for a transformative sequencing approach, clearly explaining: (1) what new approach is being unlocked, (2) why it matters, (3) what technical barriers exist, and (4) how the Phase II plan will methodically reduce risk while pursuing major performance gains.

Is the program looking for incremental improvements to existing sequencing platforms?

The FOA is designed to move beyond incremental tweaks. It prioritizes major advances in capability, performance, or architecture, and encourages applicants to explore approaches that are not currently dominant in the field.

Can proposals that improve existing sequencing systems still be eligible?

Yes, but the bar is high. The FOA calls for at least an order of magnitude improvement (roughly 10x) in a key metric such as accuracy, read length, throughput, speed, cost per base, input requirements, direct RNA performance, or another well-justified parameter that changes what is practically possible.

What does "order of magnitude improvement" mean here?

It implies roughly a 10x improvement in a meaningful performance metric (for example, accuracy, throughput, cost per base, read length, speed, or input requirements), or another clearly justified metric that would materially expand real-world usability.

Does the FOA encourage high-risk, high-reward approaches?

Yes. The announcement explicitly encourages high-risk, high-payoff projects, signaling that ambitious technical leaps can be viewed favorably when paired with a rigorous plan, credible milestones, and a strong rationale.

What kinds of sequencing technology concepts are within scope?

The scope is intentionally broad as long as the outcome meaningfully advances sequencing technology. The FOA encourages methods that represent major departures from the status quo, including approaches outside mainstream sequencing methods.

Can a company propose an end-to-end sequencing platform?

Yes. Applicants may propose complete sequencing systems that integrate an end-to-end workflow, potentially including sample handling, chemistry, detection, signal processing, basecalling, and data analysis.

Can a company propose only a component or subsystem instead of a full platform?

Yes. The FOA allows a focus on critical components where bottlenecks or unresolved technical challenges exist, as long as the work advances a novel sequencing system in a meaningful way.

What are examples of components or technical areas mentioned as in-scope?

Examples include new detection modalities; improved enzymes or molecular interactions; novel nanopore or single-molecule configurations; new surface chemistries; microfluidic approaches; signal amplification strategies; and computational methods needed to interpret new types of raw sequencing data.

Does the FOA require applicants to avoid currently dominant sequencing methods?

The FOA strongly emphasizes "methods other than those currently in use" and encourages stepping outside mainstream approaches. The intent is to catalyze new classes of sequencing technologies or major departures from dominant architectures.

What is the funding opportunity number?

The funding opportunity number is RFA HG 15 039.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA number 93.172 (also listed as 93.172 in the provided information).

When was the FOA posted?

The FOA was created and posted on October 27, 2015.

What was the closing date for applications?

The original and current closing date listed is August 7, 2016.

Is the award ceiling or the expected number of awards provided in the listing?

No. The provided information does not specify an award ceiling or the expected number of awards.

Where would an applicant typically find budget guidance and project period expectations?

Based on the listing, those details are not included here and would typically be found in the full FOA text (including any budget guidance, project period expectations, and institute-specific constraints).

What should a Phase II work plan emphasize to match the FOA's intent?

The FOA emphasizes credible milestones, a rigorous development plan, and a compelling rationale that explains how the proposed Phase II work will reduce technical risk while pursuing potentially transformative gains in sequencing capability, including (where relevant) direct RNA sequencing.

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