# Reference standards for quality control and data validation in microbiome studies

> **NIH NIH R44** · BIOCOLLECTIVE, LLC · 2020 · $763,468

## Abstract

Significant advances in high-throughput sequencing and new tools for analyzing microbiomes as
well as the demonstrated value of microbiome research in human health are driving rapid
development in this field. This rapid and exponential increase in microbiome-related studies,
however, employs a stochastic, non-standardized approach to microbiome research. As a
consequence, a large volume of data has been gathered and interpreted in different ways, not
readily comparable among laboratories and therefore, less useful. This must be remedied if
microbiome science is to pay a central role in diagnosis and therapy of disease conditions.
Because microbial community analysis can be biased by multiple technical factors, e.g., storage
conditions, DNA extraction or PCR amplification, reference standards are essential to monitor
and evaluate such variables as currently used in clinical chemistry and microbiology. We propose
that well characterized, homogeneous and stable reference standards can be used as quality
control to routinely monitor the laboratory process and to validate new methods.
The results obtained during our Pilot Study indicate that it is feasible to construct a whole genome
reference standard that can be homogenized to provide a well-defined microbiome composition
that is statistically validated and useful for quality control of microbiome studies. From these
results, the development of a reference standard is feasible, with high likelihood of success.
We will develop an SOP, optimize the process and scale to commercial quantities the
manufacturing of Microbiome Reference Standards (MRS). Each iteration of the manufacturing
process will undergo internal validations to assess achieved homogeneity and stability during
prolonged storage, as well as data reproducibility.
The market for the proposed MRS is a new market in the field of microbiome research. We are
not aware of any similar commercial product available. Our initial marketing efforts will be focused
on developing key partnerships and developing products that will be sold and distributed through
their existing sales channels.
The proposed MRS products offers a solution for the unmet need for comprehensive microbiome
quality control, addressing the need of the scientific community and NIH Human Microbiome
Project. The MRS proposed here, prepared and made available at commercial scale, will provide
microbiome practitioners with a much needed, and currently unavailable reference for quality
control and validation of microbiomes and serve as gold standard for human microbiomes.

## Key facts

- **NIH application ID:** 10004746
- **Project number:** 4R44GM134710-02
- **Recipient organization:** BIOCOLLECTIVE, LLC
- **Principal Investigator:** Raul J Cano
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $763,468
- **Award type:** 4N
- **Project period:** 2019-09-01 → 2021-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10004746

## Citation

> US National Institutes of Health, RePORTER application 10004746, Reference standards for quality control and data validation in microbiome studies (4R44GM134710-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10004746. Licensed CC0.

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