Genetic Signatures submits to FDA for clearance of GI parasite detection kit

Latest News

Australian molecular diagnostics company Genetic Signatures has submitted an application to the US FDA for regulatory clearance to market its EasyScreen Gastrointestinal Parasite Detection Kit.

The company said the US market represents a significant commercial opportunity with an estimated total addressable market of 5.5 million annual tests.

Currently, in the US, the diagnosis of gastrointestinal (GI) protozoan infections primarily relies on sample culture and microscopy, supported by antigen detection and pathogen-specific molecular tests. This approach is time-consuming, of variable reliability, labour-intensive and can take several days to provide a result.

Genetic Signatures said its EasyScreen kit provides an effective, rapid molecular test that covers the eight most common and clinically relevant GI parasites.

The kits for GI infections are already available in Australia, Europe and Canada.

The company said its 510(k) submission to the FDA includes data from 1,500 clinical samples collected from three different sites across the US.

“We are very excited to achieve this significant milestone and I am very appreciative of the hard work that has been done by the staff at Genetic Signatures, our advisors and the clinicians,” said John Melki, the managing director and CEO of Genetic Signatures.

“The US is the largest, single market for molecular diagnostic tests and represents a significant opportunity for our EasyScreen Gastrointestinal Parasite Detection Kit. With a greater range of GI parasite targets provided in this syndromic solution, and the unique advantages of our 3base technology to detect these parasites, it is the ideal product to launch into the US market. Our plan to achieve additional product registrations in the US continues, with clinical studies to support a FDA 510(k) application of a second 3base product already underway. This is a molecular syndromic test for key viral respiratory infections in a single test.”