# A Saliva Based Epigenetic Assay for Assessing Vitamin B9 and B12 Status

> **NIH NIH R43** · BD HOLDING, INC. · 2022 · $281,362

## Abstract

Gene-diet interactions can have major effects on human development, aging and response to medical
therapy. In particular, this is true for key nutrients such as Vitamin A, D, B9 and B12. Unfortunately, the current
“one size fits all” approaches for determining whether an individual has adequate levels of these and other
micronutrients relies on older studies that use serum assays that only capture recent intake that do not capture
the health care challenges incurred by our now aging, more diverse population
 We believe that integrated genetic-epigenetic assessments of saliva DNA can better capture cellular
micronutrient status and serve as a cornerstone of future Precision NutriEpigenomic therapies. Our method,
which does not require drawing blood, will be robust against day-to-day dietary intake fluctuations and can be
conducted using remote, telemedicine type approaches. This more functionally oriented method could find
widespread use in a variety of both medical and non-medical nutraceutical settings in optimizing athletic
performance, facilitating healthy aging and monitoring nutritional supplemental of both chronic (e.g., digestive
disease) and acute (e.g., chemotherapy) patients. For example, the method is generalized for the assessments
targeting the use of common supplements such as Nicotinamide Adenine Dinucleotide (NAD+).
 We hypothesize that integrated genetic-epigenetic signatures of saliva DNA will robustly predict serum B9
and B12 levels. To test that hypothesis, we will use data from a cohort of 450 African Americans for whom we
already have serum, genome wide genetic, and genome wide epigenetic data from whole blood DNA. We will
use machine learning to first mine the most predictive biosignature for serum B9 and B12 levels. Next, using our
patent-pending, proprietary techniques, we will translate that whole blood (WB) DNA based signature into a
saliva-based signature. Then, we will transform the test into an easy to perform set of methylation sensitive
digital PCR assays.
 If successful, the project will have high impact because it could lead to painless, at-home nutraceutical
testing. It is significant because certain nutrients are thought to be protective against cancer or premature
aging. Our plan is highly feasible because the large body of prior work, abundant biomaterials, and our
expertise in both epigenetics and machine learning. It is innovative because saliva diagnostics have not yet
been introduced to the nutraceutical market. The BD team is well qualified. The project will led by Dr. Rob
Philibert, an expert in epigenetic diagnostics. He will be assisted by a team of co-investigators that includes
experts in nutrition (Dr. Ruth Grossman) and biostatistics (Dr. Jeff Long). If successful, this R43 will serve as
the basis for an R44 that develop a battery of saliva based nutritional assays.

## Key facts

- **NIH application ID:** 10541702
- **Project number:** 1R43AG078082-01A1
- **Recipient organization:** BD HOLDING, INC.
- **Principal Investigator:** Robert A Philibert
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $281,362
- **Award type:** 1
- **Project period:** 2022-09-01 → 2023-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10541702

## Citation

> US National Institutes of Health, RePORTER application 10541702, A Saliva Based Epigenetic Assay for Assessing Vitamin B9 and B12 Status (1R43AG078082-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10541702. Licensed CC0.

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