Gencurix Secures Approval for Digital PCR-based EGFR Mutation Test Companion Diagnostic

14 June 2023 | Wednesday | News

Gencurix, a leading cancer molecular diagnostics company, 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
Image Source : Public Domain

Image Source : Public Domain

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.

Hyun Park, VP of Strategy & Business Development at Gencurix, stated, "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 also developing solutions for early cancer detection and minimal residual disease (MRD) screening using digital PCR technology. The company also introduced new technology detecting colorectal cancer recurrence at AACR last April.

Gencurix has been supplying diagnostic kits to major hospitals in Korea, such as Samsung Medical Center and Yonsei Severance Hospital, and has been actively expanding its global sales network, securing distributorship agreements in EuropeAsia, and other continents. In addition to collaborating with Bio-Rad, a leading manufacturer of digital PCR instruments, on marketing efforts, Gencurix is also pursuing the acquisition of new distributors.

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