Novacyt Receives Australian Approval for Its DPYD Test for Clinical Use
The Australian Therapeutic Goods Administration (TGA) has approved the marketing of the Yourgene Insight DPYD test, Novacyt announced in a press release published on November 11, 2026. The test may be supplied for clinical use by Southern Cross Diagnostics, a subsidiary acquired by the group in March 2026, beyond research use alone.
A Second Regulatory Approval in 2026 for the DPYD Test
Manufactured by Yourgene Health, the test is listed on the Australian Register of Therapeutic Goods (ARTG) as a class 3 pharmacogenetic in vitro diagnostic device. This listing is held by Southern Cross Diagnostics as the Australian sponsor.
The test detects 19 variants of the DPYD gene. It makes it possible to identify patients at increased risk of severe, and potentially life-threatening, toxicity during treatment with 5-fluorouracil (5-FU), a chemotherapy drug.
The Australian approval follows the launch of the test as a research-use-only product in May 2026, and its certification under the European IVDR regulation in September 2026. According to Novacyt, it is the first CE-marked and IVDR-certified DPYD test that includes all level 1 and level 2 variants recommended by the AMP and the NCCN.
An Australian Market Estimated at Between 16,000 and 66,000 Tests per Year
Novacyt estimates the potential market for DPYD tests in Australia at approximately 16,000 to 66,000 tests per year. Based on the current Medicare reimbursement of about 182 Australian dollars per test, the annual value of tests reimbursed to laboratories would, according to the company, range between 3.0 and 12.0 million Australian dollars.
The approval relies on the distribution network of Southern Cross Diagnostics. For Lyn Rees, Chief Executive Officer, it “demonstrates how our distribution business in Australia enables us to offer clinical customers products from across the entire Group”.
The executive places this milestone within the “strategy to develop our clinical genetics business and expand access to pharmacogenomic testing”. The DPYD test falls within precision medicine, one of the three areas of the group’s Clinical division.
