# Increased Validation of a First Method for Counting Tissue Stem Cells Specifically

> **NIH NIH R43** · ASYMMETREX, LLC · 2020 · $420,000

## Abstract

7. Project Summary
The applicant, Asymmetrex, is a pre-finance biotechnology start-up company. Asymmetrex is applying for a
Small Business Innovation Research Phase I grant to achieve technical benchmarks that will enhance its
commercial development of a new technology that addresses a major unmet need in stem cell research and
stem cell medicine. Currently, there are no methods that provide a specific and accurate count of perinatal
or postnatal tissue stem cells. Molecular biomarkers for tissue stem cells lack sufficient specificity to count
them without also counting committed progenitor cells that outnumber tissue stem cells by several orders of
magnitude. The best available, and most well-regarded, method for estimating tissue stem cell number is
the limiting dilution NOD/SCID mouse repopulation cell (LDSRC) assay. However, the LDSRC assay has
several shortcomings. It is expensive and labor-intensive, requiring many animals and several months to
perform; it conflates differences in stem cell engraftment with differences in stem cell number; and it only
works for hematopoietic stem cells (HSCs). Asymmetrex has developed a new, patented technology called
the AlphaSTEM Test™ that is able to specifically count tissue stem cells from many different perinatal and
postnatal tissues, including clinically significant tissues like bone marrow, cord blood, liver, and
mesenchymal tissues. The AlphaSTEM Test™ employs computational simulation to extract stem cell-
specific counts and cell kinetics factors from simple cell count data from serially passaged cultures. The
basic principle for the AlphaSTEM Test™ is mathematical detection of cells undergoing asymmetric self-
renewal, which is an exclusive property of perinatal and postnatal tissue stem cells. The AlphaSTEM
Test™ can also be used to detect drug candidate effects on tissue stem cells. This capability provides a
new innovative drug evaluation assay, in particular for early detection of stem cell-toxic drugs. Such drugs
cause chronic organ failure, which is a major cause of drug failure in expensive late clinical trials.
Asymmetrex has performed initial validations of the AlphaSTEM Test™ for cell therapy and drug
development applications by, respectively, comparison to published LDSRC data and evaluation of several
well-known drugs. Though positive, so far, these early validations have not proved adequate to gain the
level of industry and market buy-in needed for commercial success. Asymmetrex will employ well-vetted,
expert contract research organizations to make a head-to-head comparison of AlphaSTEM Test™ HSC
count results to LDSRC HSC estimation results; and evaluate sufficient drug candidates to estimate the
positive predictive value (PPV) of the AlphaSTEM Test™ for identifying drug candidates that are likely to fail
later in expensive clinical trials due to inducing chronic organ failure. Success in this research will increase
industry and market confidence that the AlphaSTEM Test™ is, in fa...

## Key facts

- **NIH application ID:** 10080303
- **Project number:** 1R43HL154900-01
- **Recipient organization:** ASYMMETREX, LLC
- **Principal Investigator:** JAMES L SHERLEY
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $420,000
- **Award type:** 1
- **Project period:** 2020-09-23 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080303

## Citation

> US National Institutes of Health, RePORTER application 10080303, Increased Validation of a First Method for Counting Tissue Stem Cells Specifically (1R43HL154900-01). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10080303. Licensed CC0.

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