Gencurix, a cancer molecular diagnostics company, has secured South Korea’s Ministry of Food and Drug Safety approval for its Droplex EGFR Mutation Test v2.

Droplex EGFR Mutation Test v2 has been approved as a companion diagnostic (CDx) test to detect EGFR mutations, commonly found in NSCLC patients, for the selection of anticancer therapies.

The in-vitro diagnostic (IVD) test can be used with Bio-Rad’s Droplet Digital PCR instrument and can accurately detect mutations even when plasma samples are used as the specimen.

It can detect up to 107 mutations, while most existing tests can detect up to 50 mutations, and shows high sensitivity compared to existing EGFR mutation tests using RT-PCR.

Also, the test can detect Exon 20 Insertion, a mutation that has recently gathered attention following the launches of Janssen’s Rybrevant and Takeda’s Exkivity.

Gencurix strategy and business development VP Hyun Park said: “Gencurix has been developing diagnostic products that utilize Droplet Digital PCR technology, which has primarily been used for research purposes, in the field of cancer diagnostics.

“Through years of research and development, we are proud to have achieved world-class technological capabilities and a product portfolio.”

Gencurix is a cancer diagnostics provider that has been supplying diagnostic kits to major hospitals in South Korea and is actively expanding in Europe, Asia, and other markets.

The Droplex EGFR Mutation Test v2 is the company’s second EGFR mutation test to receive regulatory approval and has been granted the CE mark approval last year.

It has obtained CE registration for nine products in its digital PCR-based IVD tests portfolio, including KRAS, BRAF, C-MET, PIK3CA, ESR1, and POLE tests.

Gencurix is also developing solutions for early cancer detection and minimal residual disease (MRD) screening using digital PCR technology.

In addition to collaboration with digital PCR instruments manufacturer Bio-Rad, the company is also pursuing the acquisition of new distributors.