HKG epiTherapeutics’ MetaGen Genetic Risk Assessment Test Receives FDA Registration, Now Available in the U.S.

FOR IMMEDIATE RELEASE

Singapore – October 31, 2024 – Epi Med Tech Global, a pioneer in genetic and epigenetic testing, is thrilled to announce the FDA registration of its MetaGen Genetic Risk Assessment Test, a 510(k)-exempt genetic variant detection system provided by its subsidiary HKG epiTherapeutics. This milestone allows MetaGen to be marketed and sold across the United States, bringing advanced genetic insights to individuals seeking personalized information. The MetaGen panel delivers a comprehensive overview of key single nucleotide polymorphisms (SNPs) across five genes (AHCY, COMT, MTHFR, MTR, MTRR) associated with critical aspects of methylation, cardiovascular health, metabolism, and neurological well-being. This registration underscores the company’s commitment to making cutting-edge genetic insights accessible globally while adhering to high regulatory standards for clinical testing.

About the MetaGen Genetic Risk Assessment Test

MetaGen is designed to offer individuals a deeper understanding of their genetic makeup and potential health predispositions. Focusing on scientifically backed SNPs, MetaGen provides insights into genetic variations known to influence health outcomes. Each report includes a summary of reputable scientific information on these genetic mutations, lifestyle recommendations, and dietary considerations found in the literature based on the user’s genetic profile. MetaGen integrates automated high-throughput next-generation sequencing (NGS) technology for precise results, analyzed through a validated bioinformatics pipeline to ensure accuracy.

The MetaGen test’s registration as a 510(k)-exempt product enables its distribution in the United States, marking a major step in the company’s expansion plans to bring advanced genetic risk assessment tools to the U.S. market.

Next Steps and Regulatory Compliance

In accordance with FDA guidelines, HKG epiTherapeutics will adhere to FDA 21 CFR 820 quality system regulations, maintaining robust documentation and technical standards. With this registration, HKG epiTherapeutics is well-positioned to serve a broader market while preparing to meet the anticipated ISO 13485 global standard requirements.

About HKG epiTherapeutics

Founded in 2016 by Dr. Moshe Szyf, a renowned figure in epigenetics, HKG epiTherapeutics operates from HKG Science Park, holding accreditations from the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). The company’s mission is to advance personalized medicine through genetic and epigenetic insights, focusing on early disease detection and preventive healthcare.

For more information about the MetaGen test, please visit epimedtech.com.

Contact:

David Cheishvili, PhD
Email: info@epimedtech.com
Phone: +852-607-25262