NEW YORK (360Dx) – Genetic Signatures today said that it has received regulatory approvals in Australia and Europe for separate enteric products.
Australia's Therapeutic Goods Administration has approved the firm's Enteric Viral Detection product. Additionally, its EasyScreen Enteric Pathogen Detection Kit range received CE-IVD marking.
The company had previously secured regulatory approval for its Enteric Protozoan, Enteric Bacterial, and C. difficile detection products, it said.
"With this important regulatory milestone comes the realization of a significant offshore opportunity and the possibility of unrestricted sales in 31 countries with a market estimated at $86 million per year," Genetic Signatures CEO John Melki said in a statement. "We will continue to work on securing similar approvals for our STI and respiratory products."
The Australian firm also said that the US Patent and Trademark Office has approved a patent covering its core 3base PCR technology. Genetic Signatures is preparing its products for approval by the US Food and Drug Administration, it said.