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Agronomics has announced that its portfolio company All G has completed the US Food and Drug Administration's Generally Recognized as Safe (GRAS) notification process for its precision-fermented bovine lactoferrin.
All G received a 'no questions' letter from the FDA, indicating the agency has no objections to the company's conclusion that its recombinant lactoferrin is safe for use in food. The decision enables commercialisation of the ingredient in the US, a key market for functional ingredients and dietary supplements.
The Australian biotech company produces next-generation milk proteins using precision fermentation. Its lactoferrin ingredient, marketed as LFX, is intended for use in functional food and beverage products, dietary supplements and early life nutrition. According to the company, the ingredient is produced via controlled fermentation and purified to defined specifications, achieving purity levels above 99.5%.
Lactoferrin is already used in the US across applications including infant formula, dietary supplements and functional foods. All G said the GRAS outcome is expected to support its wider regulatory strategy, including future use in early life nutrition and expansion into other markets.
Agronomics said the regulatory milestone supports near-term commercial activity in the US and provides a reference point for precision-fermented functional proteins more broadly, in line with its strategy of backing scalable, high-value ingredients with clear routes to market.
Jim Mellon, executive chair of Agronomics, said: "FDA clearance for All G's precision fermented lactoferrin is an important milestone for the company and for the broader precision fermentation sector. Regulatory validation of this kind reduces uncertainty around commercial deployment and supports the transition from technical development to revenue generation."
"All G operates in a category characterised by strong demand, constrained traditional supply and attractive pricing dynamics. We believe this outcome positions the company to establish itself as a supplier of high-value functional proteins to global nutrition markets."
Agronomics first invested in All G in August 2022 and has committed a total of £8.9 million to date. The holding, subject to audit, is currently valued at around £7.4 million and represents approximately 5% of the company’s most recently reported net asset value of £139.9 million as of 31 December 2025. The investor also provided an additional AUD 3 million through a convertible loan in January 2026.