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.
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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.