Image: The EasyScreen Gastrointestinal Parasite Test Kit detects the 8 most common gastrointestinal parasites (photo courtesy of 123RF)
Gastrointestinal (GI) infections are a major health problem, causing illness and death, especially in developing countries, killing an estimated 2 million children under the age of five each year. Gastroenteritis is a common gastrointestinal disease that can be caused by a variety of infectious agents and pathogenic bacteria. In addition to bacteria and viruses, certain protozoan species are important contributors to gastrointestinal diseases worldwide. Currently, the diagnosis of gastrointestinal protozoan infection is mainly based on sample culture, microscopic examination, antigen detection, and pathogen-specific molecular detection. This traditional method is notoriously time-consuming, unreliable, labor-intensive, and can take days to produce results. Rapid molecular tests can now detect eight of the most common gastrointestinal parasites, offering significant advantages over currently available diagnostic methods.
The Genetic Signatures (NSW, Australia) EasyScreen Gastrointestinal Parasite Test Kit provides rapid molecular testing covering eight of the most common and clinically relevant gastrointestinal parasites. The kit is already available in Australia, Europe and Canada. Sites adopting the kit for gastrointestinal syndrome screening have seen faster results, increased reliability and workflow efficiency. Genetic Signatures has taken steps to obtain regulatory clearance from the United States Food and Drug Administration (FDA) through a 510(k) application to market the EasyScreen Gastrointestinal Parasite Test Kit in the United States (USA). The US market represents a huge opportunity with an estimated total addressable market (TAM) of 5.5 million tests per year.
The 510(k) submission included data from 1,500 clinical specimens collected from across the United States. In particular, the kit contains gastrointestinal pathogen targets that are not currently available in other commercial products. The lack of available conclusive tests for these specific pathogenic targets required Genetic Signatures to develop new validation methods for FDA 510(k) submissions. The company is actively preparing for the expected commercial release of the EasyScreen GI Parasite Test Kit following FDA approval and is working with a US prequalified customer experience center to evaluate the kit’s performance.
“We are very pleased to have achieved this important milestone, and I am grateful for the hard work of the Genetic Signatures employees, our consultants and physicians,” said Genetic Signatures President and Chief Executive Officer John Melki. “The U.S. is the largest single market for molecular diagnostic testing, and this represents a significant opportunity for our EasyScreen gastrointestinal parasite test kit. The syndromic solution provides a greater variety of gastrointestinal parasite targets, and The unique strengths of our 3base technology for the detection of these parasites make it an ideal product for entry into the U.S. We continue to implement plans for additional product registrations in the U.S., and clinical studies are already underway to support FDA’s second 510(k) filing for 3base’s product. This is a molecular syndrome test for key viral respiratory infections in one test.”