The test can accurately identify mutations even when plasma samples are used as the specimen. Credit: OsloMetX from Pixabay.

Gencurix has received approval from the Korean Ministry of Food and Drug Safety for its companion diagnostic Droplex EGFR Mutation Test v2.

Designed to be used with Bio-Rad’s Droplet Digital PCR instrument, the test can identify EGFR mutations generally observed in non-small cell lung cancer (NSCLC) patients.

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The IVD test will help select suitable targeted anticancer therapies based on the results. Last year, the company also secured CE certification for the test in Europe.

With a capacity to detect up to 107 mutations, the test can precisely identify mutations even when plasma samples are used as the specimen.

Furthermore, the test has the potential to identify Exon 20 Insertion mutation, which grabbed more attention in the oncologist community after the launches of Takeda’s Exkivity and Janssen’s Rybrevan.

According to the company, this test shows significantly higher sensitivity compared to existing EGFR mutation tests that use RT-PCR.

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

The company supplies diagnostic kits to Korean hospitals, including Yonsei Severance Hospital and Samsung Medical Center.

It is also focused on the development of solutions for early cancer detection and minimal residual disease screening using digital PCR technology.

Last April, the company launched a new technology for the detection of colorectal cancer recurrence.

In addition, the company has European CE registration for nine products, including C-MET, PIK3CA, ESR1, POLE and KRAS tests.