# A Novel Method for Efficiently and Robustly Retrieving Circulating miRNAs

> **NIH NIH R44** · GLC BIOTECHNOLOGY, INC. · 2020 · $750,000

## Abstract

Abstract
This direct SBIR Phase II project aims to develop a novel technology and associated assays for efficiently and
robustly extracting circulating miRNAs from blood (i.e. plasma or serum), which could transform the utility of
miRNA testing in the diagnosis and monitoring of major diseases such as cancer and cardiovascular disease.
Our competitive advantage lies in the ability to retrieve circulating miRNAs more efficiently and robustly than
current extraction methods, which has been a critical barrier in implementing miRNA testing clinically. This
advantage is achieved by implementing sequence specific capture in conjunction with a propriety method of
making novel capture beads.
Circulating miRNAs are potential disease biomarkers. However, to date, there are no FDA approved miRNA
tests available. A bottleneck problem is unreliable circulating miRNA extraction. Current extraction methods
are based on adsorption of polar molecules on polar surfaces, which were originally developed to extract large
DNA and RNA molecules. However, because miRNAs are so small (~22nt), their interaction with polar
surfaces is much weaker, therefore their adsorption on polar surfaces can be easily interrupted by other
molecules present in sample. Since the weak adsorption of miRNAs on polar surfaces is an inherent problem
that cannot be fully solved even if all other conditions were optimized, new methods for retrieving circulating
miRNAs based on a different mechanism are clearly needed. Sequence-specific capture (SSC) is another
method to extract nucleic acids, but historically it performs poorly when used to extract circulating nucleic
acids from clinical samples due to the lack of effective capture beads. In addition, the cost of making capture
beads by current methods is very high, making SSC too expensive for clinical use.
Recently, we made a major breakthrough by developing a proprietary method of making capture beads that
can transform SSC from a concept to a practical method for extracting circulating miRNAs in an efficient, robust,
and cost-effective manner. Therefore, we employed our capture beads to develop our own SSC assays, and
conducted a systematic study to examine the feasibility of using our SSC assay in extracting circulating
miRNAs. Our SSC assay was indeed found to efficiently and robustly extract circulating miRNAs. In the study,
we also found that extraction efficiency of current kits varied by as much as 60-fold by plasma sample, further
confirming that current methods are not robust.
Considering the problem of current methods, unparalleled features of our SSC technology, and success of our
early study, we propose this Phase II SBIR project to further develop and validate our SSC technology for
extracting circulating miRNAs from plasma/serum, providing a foundation for its commercialization.

## Key facts

- **NIH application ID:** 10013246
- **Project number:** 5R44GM134758-02
- **Recipient organization:** GLC BIOTECHNOLOGY, INC.
- **Principal Investigator:** Qipan Deng
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $750,000
- **Award type:** 5
- **Project period:** 2019-09-09 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10013246

## Citation

> US National Institutes of Health, RePORTER application 10013246, A Novel Method for Efficiently and Robustly Retrieving Circulating miRNAs (5R44GM134758-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10013246. Licensed CC0.

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