Novacyt (AIM:NCYT) announced it has won Australian regulatory approval for its Yourgene Insight DPYD assay, opening the door to clinical diagnostic sales in the country beyond the research-use market it has served to date.
The molecular diagnostics company, listed on AIM as NCYT and on Euronext Growth Paris as ALNOV, said the Therapeutic Goods Administration (TGA) has cleared the assay for supply, with Southern Cross Diagnostics Pty, the Australian arm of the Novacyt Group, holding the sponsor registration under the Australian Register of Therapeutic Goods for Class 3 pharmacogenetic in vitro diagnostic devices.
The assay detects 19 clinically relevant variants in the DPYD gene, flagging patients at heightened risk of severe or potentially fatal toxicity from 5-fluorouracil chemotherapy treatment.
Novacyt estimates the addressable Australian market at between roughly 16,000 and 66,000 tests a year, which at the current Medicare reimbursement rate of approximately A$182 per test implies a total annual reimbursed value to laboratories of roughly A$3.0 million to A$12.0 million.
The approval follows the assay's launch as a research-use-only product in May and its certification under the European Union's In Vitro Diagnostic Regulation (IVDR) in September.
Novacyt describes the Yourgene Insight DPYD assay as the first CE-marked DPYD test certified under IVDR to incorporate all current Tier 1 and Tier 2 variants recommended by both the Association for Molecular Pathology and the National Comprehensive Cancer Network.
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Southern Cross Diagnostics was acquired by the Group in March, giving Novacyt a distribution channel into Australia and the wider Asia-Pacific region.
"Australian approval expands the commercial opportunity for our Yourgene Insight DPYD assay into routine clinical testing," said Lyn Rees, chief executive officer of Novacyt.
"Following IVDR certification in September, this approval advances our international expansion and demonstrates how our Australian distribution business can bring products from across the Group to clinical customers," he said, adding that it supports the Group's strategy to grow its clinical genetics business and broaden access to pharmacogenomic testing.