# A Comprehensive qPCR-Based Oral Microbiome Profiling Platform for Research and Discovery

> **NIH NIH R43** · BRANCHPOINT BIOSCIENCES INC. · 2024 · $409,403

## Abstract

The oral microbiome plays a crucial role in dental health and can offer insights into a wide variety of systemic
conditions. Next-generation sequencing (NGS) has been used to study the oral microbiome, but 16S amplicon
sequencing and shotgun metagenomic sequencing have severe limitations as tools for biomarker discovery
and clinical diagnostics. Saliva is a readily available sample type that contains over a billion microbes per mL,
but the signal from low abundance microbes and correct species identification can be difficult to detect without
deep, expensive shotgun metagenomic sequencing. qPCR-based molecular detection can overcome the
limitations of NGS methods by offering specificity, sensitivity, and quantification down to single digit copy
numbers. Branchpoint Biosciences, an early-stage start-up, has developed a qPCR platform technology to
create a new generation of qPCR assays. Our new method combines cutting-edge knowledge of genomic
databases and microbial evolution within a proprietary software suite that enables the rapid and accurate
design of discriminatory primers and probes capable of detecting target microorganisms without
cross-reactivity. We have de-risked the underlying software suite, established in silico and in vitro validation
methods, and successfully demonstrated a proof-of-concept panel consisting of 106 validated qPCR assays
with high specificity and sensitivity of microbial targets in complex samples. In this Phase 1 proposal, we plan
to develop a comprehensive oral qPCR panel through the following aims: (1) determine oral panel targets by
ascertaining abundance and prevalent microbes in the oral microbiome from 926 public metagenomic samples
studying six different disease phenotypes; and (2) design and validate qPCR assays targeting the identified
microbes. A comprehensive qPCR panel of oral species creates a cost-effective research tool that does not
require expensive pre- and post-processing steps associated with NGS techniques and can quantify all the
Bacteria and Archaea commonly present in the human oral cavity. This panel will provide researchers and
clinicians with an alternative to NGS techniques and enable large-scale cohort and/or detailed longitudinal
studies for monitoring disease progression and therapeutic response. Successful completion of this Phase 1
proposal will result in the (1) identification of microbial targets and (2) demonstrate validated qPCR assays that
accurately screen the oral microbiome. This work will precede a Phase 2 proposal that quantifies the
advantages of generating a microbiome profile with our oral comprehensive panel compared to NGS, such as
lower cost, faster turnaround time, superior detection, and quantitative values. Our novel platform technology
enables a new, comprehensive, and cost-effective approach for discovering and leveraging microbial
biomarkers for clinical research and sets the stage for the future development of microbiome-based monitoring
platforms, screening t...

## Key facts

- **NIH application ID:** 10918615
- **Project number:** 1R43DE033567-01A1
- **Recipient organization:** BRANCHPOINT BIOSCIENCES INC.
- **Principal Investigator:** Benjamin Tully
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $409,403
- **Award type:** 1
- **Project period:** 2024-08-07 → 2026-08-06

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10918615

## Citation

> US National Institutes of Health, RePORTER application 10918615, A Comprehensive qPCR-Based Oral Microbiome Profiling Platform for Research and Discovery (1R43DE033567-01A1). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10918615. Licensed CC0.

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