# Safe and Effective Whole Blood ID/AST Device for Use in Neonatal ICU Settings

> **NIH NIH R44** · GENEFLUIDICS, INC. · 2021 · $962,488

## Abstract

Abstract
The key objective of this proposed Phase IIB SBIR Competing Renewal effort is to continue the
process of developing pediatric products of the ongoing SBIR Fast Track R44HD084033 that
require approval of a federal regulatory agency (FDA), and this Phase IIB stage research and
development is necessary to move closer to commercialization as stated for NICHD IIB
requirements in PHS 2018-2 Omnibus Solicitation for SBIR/STTR Grant Applications and PA-
18-573.
 In addressing NICHD Pregnancy and Perinatology Branch’s (PPB) top priority topic of
“Rapid methods for diagnosis of bacterial infections and inflammation; antibiotic sensitivity,”
and PPD’s supported research area of “diagnostics, monitoring, and therapeutic devices and
instruments for newborn infants in the nursery and in Neonatal ICU (NICU) setting,” we add
Gram positive pathogens to the current Gram negative pathogen identification (ID) panel and
additional first line empirical antibiotics to antimicrobial susceptibility testing (AST) panel to
address healthcare associated infections (HAIs) in nursery and NICU settings.
 The proposed hypothesis-driven, milestone driven IIB study is based on the analytical
and clinical testing plans and protocols negotiated with FDA through pre-sub meetings for
510(k) de novo submission for in vitro diagnostics (IVD) devices as outlined in the CLINICAL
REGULATORY PROGRESS section of COMMERCIALIZATION PLAN. The scope of
work of this IIB study on NicuMax® is to carry out analytical validation and non-interventional
clinical testing required by FDA to demonstrate safety and effectiveness of the pediatric ID/AST
system developed to address two major challenges of blood culture for neonatal sepsis listed
below through the current NICHD SBIR Fast Track project.
Major challenges of current FDA cleared
blood culture systems using pediatric bottles
Progress from current SBIR Fast Track
for neonatal sepsis in NICU settings
1. Procurement of insufficient blood volume (less
than 1-3 mL as needed) for blood culture system
designed for adults
Blood collection tube and system designed to
take blood volume of 200 uL to 2 mL.
2. Long blood-to-result time (>24 hours) for
culture-positive, culture-negative and antimicrobial
susceptibility. Traditional AST is still needed for
PCR-based system.
Pathogen ID (6 hours) + AST (2 hours) = 8
hours from blood to complete ID/AST before
the 2nd administration of empirical antibiotic
The current Fast Track R44HD084033 project does not include FDA analytical and clinical
demonstration of substantial equivalency to FDA cleared devices, since it’s not a research topic
covered by Phase I/II effort and there is not a predicate device cleared by FDA specifically for
infants in NICU and nursery settings. Based on the close communications with FDA, this Phase
IIB effort focuses on three major criteria outlined by FDA:
Top Priority Risk Factors Risk Management and Mitigation Recommended by FDA
Effectiveness and safety of testing
limited bloo...

## Key facts

- **NIH application ID:** 10144009
- **Project number:** 5R44HD084033-06
- **Recipient organization:** GENEFLUIDICS, INC.
- **Principal Investigator:** Vincent Jen-Jr Gau
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $962,488
- **Award type:** 5
- **Project period:** 2015-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10144009

## Citation

> US National Institutes of Health, RePORTER application 10144009, Safe and Effective Whole Blood ID/AST Device for Use in Neonatal ICU Settings (5R44HD084033-06). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10144009. Licensed CC0.

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