Novacyt Climbs on Australian Test Approval

Novacyt (LON: NCYT) shares closed 7.5% higher today after the diagnostics group said Australia’s medicines regulator had approved its Yourgene Insight DPYD test for clinical use. The Anglo-French company makes PCR and genetic tests and is listed on AIM, London’s market for smaller growth companies.

The shares ended the session at 37.1p, up 2.6p from yesterday’s close of 34.5p. They opened at 37.58p and traded between 36.256p and 38p on volume of 48,367, against 2,396 yesterday.

Novacyt said in a 7am announcement, before the London open, that Australia’s Therapeutic Goods Administration had approved the assay, a laboratory test. It detects 19 variants in the DPYD gene, which affects how patients process chemotherapy and can raise the risk of severe or fatal toxicity from 5-fluorouracil, a common chemotherapy drug.

Until now the test could be sold in Australia only for research use, meaning it could not guide patient decisions. Southern Cross Diagnostics, Novacyt’s Australian subsidiary, registered it as a class 3 device, a higher-risk medical-device category, and can now sell it for patient testing.

The approval is the third step for the product, after a research-use launch on the 19th of May and an EU IVDR-certified launch on the 8th of September. IVDR is the EU rulebook for diagnostic devices. It also suggests the Australian distribution business can carry group products.

Novacyt estimates Australian demand at 16,000 to 66,000 tests a year. At the Medicare rate of about A$182 a test, Australia’s public health insurance scheme, that is A$3.0m to A$12.0m a year paid to laboratories. Trailing-twelve-month revenue is about £21.8m.

The rise follows a slide from 44p on the 6th of October to 34.3p on Thursday. At 37.1p the shares remain 16% below that October level and under their 50-day average of 40.43p, and the market value is about £25.0m.

The company lost £23.3m on revenue of £20.39m in 2025, and the estimate above is its own.