Epigenomics AG

Epigenomics AG specializes in in vitro diagnostic (IVD) kits that use nucleic acid techniques to detect methylated DNA. Their primary focus is on assays like the Epi proColon, which analyzes methylation patterns in stool samples to assess colorectal cancer biomarkers. These products are designed exclusively for laboratory use to support clinical testing.

Epigenomics AG is headquartered in the United States. Their devices fall under the FDA’s Class III regulatory category, which applies to high-risk diagnostic products requiring premarket approval. This classification reflects the critical role of their methylated DNA assays in disease detection and diagnosis.

Epigenomics AG’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class III IVD products, particularly those like their methylated DNA kits, which undergo stringent premarket evaluation.

The FDA categorizes Epigenomics AG’s methylated DNA IVD kits as Class III because they are intended to diagnose or detect serious conditions like colorectal cancer. Class III classification applies to devices with substantial risk to patients, necessitating rigorous premarket approval to ensure safety and effectiveness before commercialization.