Diagnostics Pipeline: Company Receives NIH Grant to Develop Test for Type 1 Diabetes Progression

Metabolon has received a grant from the National Institutes of Health (NIH) to develop a test that would better predict when adults’ type 1 diabetes will change from being mostly asymptomatic to requiring regular treatment with insulin.

“With this NIH grant, Metabolon is poised to extend its expertise in [type 1 diabetes], aiming to enhance predictive capabilities and improve the lives of millions affected by this condition,” said Metabolon CEO Ro Hastie in a statement.¹

The Morrisville, NC-based Metabolon offers diagnostic testing connected to detecting the presence or absence of more than 1,000 metabolites, including fatty acids, amino acids, cannabinoids, and complex lipids, among others. The company has raised $259.7 million in funding, according to Crunchbase.² That includes a $60 million credit facility in May from Trinity Capital to expand research and development and fund its growth efforts.³ It raised an earlier $25 million round of funding in January 2023.⁴

Potential impact of the test

Diabetes is a scourge in the US. The disease is connected to 7.9 million hospital discharges in the US in 2020, including 1.7 million for major cardiovascular diseases and 160,000 for lower extremity amputations.⁵ It is also linked to numerous catastrophic conditions, including kidney failure, blindness, low resistance to infections, and premature death.

Type 1 diabetes is typically first detected through testing of blood sugar levels, although those with the type 1 version of the disease can suddenly manifest symptoms such as the need to urinate frequently, increased thirst and hunger, blurred vision, and fatigue.

Type 1 diabetes is the less common version of the disease, which is more often diagnosed in children and adolescents.⁶ Its incidence in the US has been rising. According to the Centers for Disease Control and Prevention, cases of type 1 diabetes rose about 10 percent from 2003 to 2018. During that time period, the incidence of diabetes rose the most among non-Hispanic Black people, with a nearly 30 percent jump in cases. However, the rate of type 1 diabetes in this ethnic group is still slightly below the US average.⁵

Details of the NIH grant

According to Metabolon associate director Adam Kennedy, the company received the first phase of a two-phase “fast track” grant for $300,000 as part of the NIH’s Small Business Innovation Research program.

“The grant is not technically renewable, but after the phase one work is completed, we would need to write a progress report. After review of the phase one progress report, Phase two would then be awarded in one-year increments,” Kennedy said in an email. He added that a phase two grant would last for two additional years.

Currently, Metabolon does not have any tests connected to type 1 diabetes. It has validated tests for insulin resistance and impaired glucose tolerance, which the company’s website says is focused on 22 specific metabolites.⁷ Kennedy said both of those tests help evaluate predecessor stages of type 2 diabetes, which occurs in both adults and children, usually among those who struggle with obesity.  

“The reason we pursued this grant was to develop a metabolomics-based test for type 1 diabetes,” Kennedy said.

Metabolon’s work on type 1 diabetes tracking is currently in its feasibility stage, Kennedy said.

“We will be leveraging our global platform, which will bring all our strengths to bear to identify the best and most specific biomarkers for identifying type 1 disease signatures,” he said. “Once we have finished this and other preliminary validation studies, we plan on publishing our results in peer-reviewed journals and presenting at conferences around the world.”

References:

1. 1. https://www.metabolon.com/news/nih-grant-advanced-monitoring-predictive-tools-type-1-diabetes/

1. 1. https://www.crunchbase.com/organization/metabolon/company_financials

1. 1. https://www.metabolon.com/news/metabolon-secures-60-million-credit-facility-to-drive-growth-and-innovation/

1. 1. https://www.prnewswire.com/news-releases/metabolon-secures-25-million-of-funding-to-accelerate-growth-301728774.html

1. 1. https://www.cdc.gov/diabetes/php/data-research/index.html

1. 1. https://my.clevelandclinic.org/health/diseases/21500-type-1-diabetes

1. https://www.metabolon.com/services/target/diabetes-research-markers/

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