Molecular diagnostic company Genetic Signatures has submitted an application seeking US Food and Drug Administration approval for its EasyScreen Gastrointestinal Parasite Detection Kit.
The easy to use kit aims to replace current screening methods which involve sample culturing and microscopic inspection, antigen detection and pathogen-specific molecular tests,
Genetic Signatures said the US market for the detection kit was 5.5 million tests per annum.
Managing Director and CEO of Genetic Signatures CEO Dr John Melki said the FDA application was a significant milestone for the company.
“The US is the largest single market for molecular diagnostic tests and represents significant opportunity for our EasyScreen.
“With a greater range of GI parasite targets provided in this solution, and the unique advantage of our 3base technology to detect these parasites, it is an ideal product to launch into the US market.”
Clinical studies are underway to support a future FDA application for the company’s 3base core infectious diseases pathology screening technology.
The EasyScreen Gastrointestinal Parasite Detection Kit is a test for the eight most common and clinically relevant GI parasites.
EasyScreen test kits are already available in Australia, Europe and Canada.
Genetic Signatures has begun preparation for a commercial US launch of the kits and has recruited additional sales and support staff, and developed US warehousing and laboratory facilities.
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Picture: Genetic Signatures