FDA grants 510(k) clearance to Genetic Signature for parasitic GI infection kit

Lab Petri Microbiology Social

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Genetic Signature's EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated molecular workflow.

The multiplex polymerase chain reaction (PCR) assay for gastrointestinal (GI) parasites tests for eight of the most common, clinically relevant gastrointestinal parasites from a single patient sample, the Newtown, Australia-based firm said in a statement, with same-day results. The eight parasites tested for include some of those most prevalent in the U.S., including Giardia duodenalis (G. intestinalis and G. lamblia), Cryptosporidum, and Entamoeba histolytica, as well as Cyclospora cayetanensis, Blastocystis hominis, Dientamoeba fragilis, Enterocytozoon bieneusi (Microsporidia), and Encephalitozoon intestinalis (Microsporidia).

Genetic Signatures noted that the EasyScreen molecular diagnostic provides an alternative to costlier, more complex enteric lab-developed tests. Moreover, in the U.S., the diagnosis of parasitic GI infections is primarily through microscopy, which can be time-consuming, labor-intensive, and it requires specialized training and has varied reliability.

Parasitic GI infections remain a global concern; often transmitted through water, food, or surfaces, they often spread through family contact and international travel. Approximately 3.5 billion people are infected globally per year; approximately 65 million people in the U.S. are infected per year. The healthcare, social, and economic burdens are considerable.

"Securing FDA clearance marks a major milestone for Genetic Signatures," Neil Gunn, interim CEO of Genetic Signatures, said. "We are excited to offer patients and customers a new solution to a major health care issue in the U.S."

Gunn added that Genetic Signatures has already established a team in North America to assist labs with introducing the EasyScreen kit, which is already available in Australia, Canada, and the European Union.

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