[Special Stock] EnGen Bio Diagnoses 145 Gene Fusion Variants Including 33 FDA Companion Diagnostic Targeted Therapies at Once

EnGen Bio is showing strong performance. The news that it has successfully developed and commercialized the 'ONCOaccuPanel RNA' panel analysis technology for diagnosing gene fusion mutations in solid cancer patients on its NGS-based cancer gene analysis platform 'NGeneAnalySys' for the first time in Korea appears to be influencing its stock price.

As of 9:46 AM on the 6th, EnGen Bio is trading at 2,400 KRW, up 9.34% from the previous day.

NGeneAnalySys has expanded from DNA analysis to include RNA analysis, enabling simultaneous analysis of fusion mutations in 145 genes with high sensitivity and accuracy. This allows for fast and cost-effective diagnosis of many types of targeted therapies.

The demand for NGS-based precision cancer diagnostics is growing because a single test can simultaneously identify hundreds of gene mutations that cause cancer and diagnose the most suitable targeted therapy for the patient. To effectively treat cancer patients, the diagnostic approach is shifting from traditional cancer diagnosis methods to NGS-based precision cancer diagnostics. Since the US FDA approved companion diagnostics using NGS panels in 2017, the NGS diagnostic market has rapidly expanded.

EnGen Bio’s diagnostic platform now supports not only the newly added RNA analysis technology but also targeted therapy-specific mutation classification, including EGFR activating mutations, HER2 positivity, and MET Ex14 skipping mutations. As of July, it includes 96 approval records based on 33 targeted therapies, including seven items approved as FDA companion diagnostics (CDx), such as AstraZeneca’s lung cancer treatment Osimertinib (Tagrisso), Genentech’s breast and gastric cancer treatment Trastuzumab (Herceptin), and Bayer’s NTRK fusion mutation companion diagnostic Larotrectinib (Vitrakvi).

Choi Dae-chul, CEO of EnGen Bio, said, "NGeneAnalySys supports accurate and rapid detection and interpretation of important mutations, providing clinicians with essential information to establish patient-tailored treatment strategies." He added, "By reflecting the latest treatment guidelines and companion diagnostic approval status, we have enhanced the applicability of cancer patient treatment in clinical settings."

He emphasized, "Through this, we have taken a step closer to realizing precision medicine and personalized treatment," and "We expect it to contribute to improving patients’ prognosis and quality of life."