Gencurix has received approval from Australia’s Department of Health and Aged Care, Therapeutic Goods Administration for its Droplex POLE Mutation Test.

The Droplex test is intended for endometrial cancer mutations.

Leveraging Droplet Digital PCP (ddPCR) technology, the test analyses POLE gene mutations in patients with endometrial cancer, thereby enabling genetic abnormalities detection.

It is claimed to be the first digital polymerase chain reaction (PCR)-based kit for identifying POLE mutations.

Gencurix noted that unnecessary treatments can be potentially reduced by prioritising treatment for POLE gene mutations while improving treatment outcomes.

Last year, the company received CE certification for the Droplex POLE Mutation Test. In August this year, the Tata Memorial Centre in India started using the device.

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.

In a statement, a Gencurix representative said: “Gencurix has been in discussions with major cancer hospitals in Australia for the introduction of Droplex endometrial cancer testing.

“Additionally, Gencurix has applied for the inclusion of other Droplex CDx tests in the Australian Register of Therapeutic Goods. Gencurix is determined to leverage this approval to expand into other MDSAP member countries.”

In June this year, Gencurix obtained approval from the Korean Ministry of Food and Drug Safety for its companion diagnostic, Droplex EGFR Mutation Test v2.

The test is designed to be used with Bio-Rad’s ddPCR instrument and can identify EGFR mutations generally observed in patients with non-small cell lung cancer.