Skip to main content
Premium Trial:

Request an Annual Quote

Genetic Signatures Gets FDA 510(k) Clearance for GI Parasite Detection Kit

NEW YORK – Australian molecular diagnostics firm Genetic Signatures said Tuesday that it has received US Food and Drug Administration 510(k) clearance for a syndromic enteric protozoa detection test.

The firm's PCR-based EasyScreen Gastrointestinal Parasite Detection Kit is used to identify infection with eight of the most common and clinically relevant GI parasites. The targets are Giardia duodenalis, Cryptosporidium, Entamoeba histolytica, Cyclospora cayetanensis, Blastocystis hominis, Dientamoeba fragilis, Enterocytozoon bieneusi, and Encephalitozoon intestinalis.

"Our unique 3base technology offers significant differentiation and advantages for molecular testing of the most challenging samples and gastrointestinal parasites that impact over 60 million patients a year in the US," Genetic Signatures interim CEO Neil Gunn said in a statement.

Gunn said that the firm has established a dedicated team in North America that will help laboratories introduce the firm's testing technologies.

Marc Couturier, a medical director at ARUP Laboratories, added that the EasyScreen assay provides labs with an alternative to maintaining their own laboratory-developed tests as the agency increases its oversight of those tests.

Genetic Signatures previously noted that its protozoa test kits are already available in Australia, Europe, and Canada, and the firm has said at least since 2020 that it planned to bring its GI parasite detection kit to the US market. The firm also said last week that it had halted development for the US market of a real-time PCR-based EasyScreen Essentials Respiratory Detection Kit in response to a competitive yet shrinking market for molecular testing for respiratory pathogens, noting that it would instead focus on the EasyScreen launch.

Genetic Signatures also announced this week that its board of directors has appointed Allison Rossiter as CEO. She most recently served as managing director of Roche Diagnostics’ Australia business.