Gencurix Inc. has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2. This product is a companion diagnostic test designed to detect EGFR mutations commonly found in NSCLC patients and guide the selection of appropriate targeted anticancer therapies based on the test results. It is an IVD product that can be used with Bio-Rad's Droplet Digital PCR instrument and has also obtained CE certification in Europe last year.

Compared to existing EGFR mutation tests using RT-PCR, this product demonstrates significantly higher sensitivity. This makes it capable of accurately detecting mutations even when plasma samples are used as the specimen. Additionally, while most existing products detect fewer than 50 mutations, this test can detect up to 107 mutations, further enhancing its accuracy.

Notably, this product has an additional strength in its ability to detect Exon 20 Insertion, a mutation that has recently garnered significant attention in the oncologist community following the launches of Janssen's Rybrevant and Takeda's Exkivity. Among the existing single gene tests, there were no tests available to properly detect this mutation, necessitating the use of costly and time-consuming NGS tests. This is the second EGFR mutation test for which Gencurix has obtained approval.

In addition, Gencurix has obtained European CE registration for a total of nine products, including KRAS, BRAF, C-MET, PIK3CA, ESR1, and POLE tests, making it the company with the highest number of digital PCR-based IVD tests in its portfolio.