Gencurix Receives Australian Government Approval for Droplex POLE Mutation Test

12 October 2023 | Thursday | News

Gencurix, a cancer molecular diagnostics company, has obtained approval from the Australian Government (The Department of Health and Aged Care, Therapeutic Goods Administration) for its Droplex POLE Mutation Test targeting endometrial cancer mutations.
Image Source : Public Domain

Image Source : Public Domain

This test employs Droplet Digital PCP (ddPCR) technology to analyze POLE gene mutations in endometrial cancer patients, facilitating the detection of genetic abnormalities. Prioritizing treatment for POLE gene mutations can potentially reduce unnecessary treatments and improve prognosis and treatment outcomes. The Droplex POLE Mutation Test is the first digital PCR-based kit for detecting POLE mutations.

Australia is a member of the Medical Device Single Audit Program (MDSAP), which covers 50% of the global medical device market, including the United StatesJapanCanadaBrazil, and Australia. This approval indicates that Gencurix's Droplex test meets global performance and reliability standards.

A representative from Gencurix noted, "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."

The Droplex POLE Mutation Test received CE certification last year, and Tata Memorial Centre in India started using it in August this year.

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