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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.