EpiMedtech Global Announces FDA Registration of EPIAGE, the First Epigenetic Age Test Registered by the FDA

November 18, 2024 – Singapore – EpiMedtech Global, a leader in genetic and epigenetic testing, is proud to announce that EPIAGE, an epigenetic test for measuring biological age, has been registered with the FDA. This innovative product, based on next-generation sequencing (NGS) technology, is the first epigenetic age test in the world to be registered by the FDA.

What is EPIAGE?

EPIAGE is a highly accurate test that measures biological age using DNA methylation analysis. It provides exceptional insights into the aging process, offering the following advantages:

Next-Generation Sequencing (NGS) Technology: Utilizes cutting-edge technology to ensure maximum sensitivity and reliability in measuring DNA methylation patterns. Unlike other tests on the market, which rely on array technology known for batch effects and inconsistencies when tests are repeated over time, EPIAGE sets a new standard for precision and reproducibility.
Triple Sequencing of Each Sample: EPIAGE is the only test on the market that utilizes this unique process, sequencing each sample three times. This approach allows for precise measurement of technical error, enabling customers to confidently distinguish between true biological effects from interventions and technical noise in the results.
Accuracy and Reproducibility: EPIAGE delivers transparent data on technical variations, making it the only test on the market with this capability, setting a new standard in reliability for biological age measurements.

Why is EPIAGE Unique?

EPIAGE is the only epigenetic age test registered with the FDA, which signifies that the product is officially listed in the FDA’s database and meets regulatory requirements for marketing in the United States. FDA registration ensures that the test complies with applicable standards for safety, quality, and reliability as outlined in its classification under the Genetic Variant Detection and Health Risk Assessment System (21 CFR 866.5950).

To maintain the highest standards, EPIAGE samples are analyzed in laboratories accredited by CAP (College of American Pathologists) and CLIA (Clinical Laboratory Improvement Amendments), guaranteeing accuracy and rigorous testing protocols. Additionally, the process adheres to HIPAA (Health Insurance Portability and Accountability Act) standards, ensuring the confidentiality and security of customer data.

Second Version of EPIAGE

The current version of EPIAGE represents the second generation of the test, developed based on the analysis of more than 600 samples. These studies cover a wide age range—from children to the elderly—demonstrating the test’s accuracy and reliability across all age groups.

One of EPIAGE’s most significant strengths is its precision in detecting small changes in biological age. The standard deviation of triplicate measurements averages only one year. This exceptional level of accuracy makes EPIAGE ideal for intervention studies, where researchers or customers can evaluate whether changes in biological age are due to genuine biological effects or fall within the test’s technical variation.

For example, when assessing the impact of a lifestyle intervention or treatment, such as diet changes, exercise, or novel therapies, the minimal technical noise ensures that observed changes in biological age reflect true biological responses.

Scientific Transparency

The algorithm and gene used in the development of EPIAGE will soon be published in a scientific journal, ensuring transparency and scientific validation. The gene underlying the test is one of the most cited in the field of epigenetic age research, further solidifying EPIAGE’s position as a scientifically robust and trusted tool for biological age measurement.

The Future of EpiMedTech Global

EpiMedTech Global continues to develop its technologies, making advanced epigenetic tests available to everyone. EPIAGE represents a leap forward in epigenetic testing, paving the way for future advancements where biological age insights improve healthspan and quality of life.

For more information, visit: www.epimedtech.com.