Novacyt reports Australian approval for 19‑variant chemotherapy test
Southern Cross Diagnostics can supply the DPYD assay for clinical use, but Novacyt has not dated its Australian commercial rollout.
Adrian Kessler
Clinical supply of a chemotherapy-toxicity assay is now authorised in Australia after Novacyt S.A. EPAALNOV LONNCYT reported approval for its 19-variant test on Wednesday.
The company's Nov. 11 release says the Therapeutic Goods Administration has approved supply of its Yourgene Insight DPYD assay for clinical diagnostic use. Southern Cross Diagnostics, its Australian subsidiary, holds the Australian Register of Therapeutic Goods inclusion for Class 3 pharmacogenetic in vitro diagnostic devices.
Novacyt is a small molecular diagnostics group headquartered in France, developing genetic tests and instruments for clinical and research laboratories across international markets.
Shares were quoted at €0.43, up 0.58 per cent, on Euronext Growth Paris at 12:56 p.m. CET on Wednesday, according to the EPAALNOV quote. The approval permits clinical supply, but Novacyt gave no date for first commercial sales or forecast of Australian assay revenue.
Clinical Access Follows European Certification
The assay detects clinically relevant variants in the DPYD gene to help identify patients at increased risk of severe or potentially fatal toxicity during treatment with 5-fluorouracil. Its results provide information for treatment decisions; the announcement does not report a clinical trial measuring a reduction in toxicity.
The Australian authorisation extends the product beyond research use, following its research-only introduction in May and European Union IVDR certification in September. Those earlier steps established the product's development and European regulatory position, while the Australian inclusion permits local clinical supply through Southern Cross.
Novacyt did not identify the ARTG entry number or the inclusion's effective date in its release. The register entry was not independently reviewed, so the account of the authorised use rests on the company's announcement.
"Australian approval expands the commercial prospects for our Yourgene Insight DPYD test in routine clinical testing. Through Southern Cross Diagnostics, we can now offer Australian laboratories a registered diagnostic test to help identify patients at increased risk of severe chemotherapy toxicity," Novacyt chief executive Lyn Rees said in the release, translated from French.
The listed pharmacogenetic testing peer genedrive plc LONGDR addresses a different treatment decision. Its CYP2C19 ID Kit, described on its product page accessed Nov. 11, identifies six genetic variants to inform antiplatelet treatment.
Novacyt says its DPYD assay incorporates all current Tier 1 and Tier 2 variants recommended by the Association for Molecular Pathology and the National Comprehensive Cancer Network. The company describes it as the first CE-marked DPYD assay certified under IVDR to include that full recommended set. These are the manufacturer's coverage claims; the announcement provides no head-to-head performance comparison with another assay.
Reimbursement Defines The Market Estimate
Novacyt estimated on Nov. 11 that Australia's potential DPYD testing market spans approximately 16,000 to 66,000 tests annually. It based its valuation on current Medicare reimbursement of approximately A$182 per test.
On that Nov. 11 basis, the company put the annual value of testing reimbursed to laboratories at approximately A$3 million to A$12 million. Those figures value laboratory testing, leaving Novacyt's potential revenue from supplying assay kits unspecified.
The release gives no Australian customer count, order volume or market-share target. Southern Cross provides an existing distribution route, but the approval alone supplies no measure of laboratory adoption or recurring demand.
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First Australian clinical sales are the next commercial milestone to establish. Novacyt's Nov. 11 announcement gave no rollout date, leaving the timetable for converting the registration into revenue unconfirmed.
