Companion Diagnostics
In NSCLC(non-small cell lung cancer), companion diagnostics are essential tools used to guide treatment decisions, especially for targeted therapies. These diagnostics test for specific genetic mutations in a patient’s tumor tissue to determine whether a particular drug will be effective.
Epinode provides a PCR kit for detecting ROS1 mutations in NSCLC, enabling companion diagnostics that allow patients with ROS1-positive tumors to be treated with Pfizer’s crizotinib. Epinode is also developing products for the detection of EGFR and KRAS genetic mutations.
Cancer Early Diagnostics
Early detection of cancer significantly increases the chances of successful treatment and survival. Liquid biopsy is an advanced, minimally invasive technique that can detect cancer-related genetic material (like circulating tumor DNA) in a simple blood sample—even before symptoms appear or tumors are visible through imaging. Epinode is currently preparing for the blood-based epigenetics test for the early detection of colorectal cancer, liver cancer and pancreatic cancer through a partnership with Singlera Genomics.
Cancer Monitoring
Cancer monitoring is crucial for detecting minimal residual disease (MRD) remaining after treatment.
Identifying MRD early helps predict the risk of recurrence before symptoms appear. Timely intervention based on MRD monitoring can improve outcomes and long-term survival.
Regulatory Affairs for Medical Devices
Epinode focuses on regulatory affairs for medical devices provides expert services to help manufacturers navigate the complex legal and regulatory requirements needed to bring medical devices to market.
Our key roles include:
Preparing and submitting regulatory technical documents
Managing product registration and approvals
Supporting clinical evaluations and post-market surveillance
Advising on labeling, risk management, and regulatory strategy
Licensing In/Out