Rapid Molecular Test Detects Eight Most Common and Clinically Relevant Gastrointestinal Parasites
Posted on 06 Sep 2023
Gastrointestinal (GI) infections are a significant health concern, causing illness and mortality, especially in developing countries where they claim the lives of approximately two million children under five each year. Gastroenteritis, a common GI illness, can be caused by various infectious agents and pathogenic bacteria. In addition to bacteria and viruses, certain protozoa species are major contributors to GI illnesses worldwide. Presently, the diagnosis of GI protozoan infections relies mainly on sample culture, microscopy, antigen detection, and pathogen-specific molecular tests. This traditional approach is well-known for being time-consuming, variable in reliability, labor-intensive, and can take days to yield results. Now, a rapid molecular test can screen for eight of the most common GI parasites, offering significant advantages over currently available diagnostic methods.
The EasyScreen Gastrointestinal Parasite Detection Kit from Genetic Signatures (NSW, Australia) offers a rapid molecular test covering the eight most common and clinically relevant GI parasites. This kit is already available in Australia, Europe, and Canada. Sites that have adopted this kit for syndromic GI screening have experienced faster results, increased reliability, and workflow efficiencies. Genetic Signatures has taken steps to obtain regulatory clearance from the Food and Drug Administration (FDA) through a 510(k) application to market the EasyScreen Gastrointestinal Parasite Detection Kit in the United States (US). The US market represents a substantial opportunity, with an estimated total Addressable market (TAM) of 5.5 million tests annually.
The 510(k) submission includes data from 1,500 clinical samples collected from various sites across the US. Notably, this kit includes GI pathogen targets that are not currently available in other commercial products. The absence of available predicate tests for these specific pathogen targets required Genetic Signatures to develop new validation methods for the FDA 510(k) submission. The company is actively preparing for the anticipated commercial launch of the EasyScreen Gastrointestinal Parasite Detection Kit upon FDA clearance and is collaborating with pre-qualified customer experience sites in the US to assess the kit's performance.
“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, Managing Director and CEO of Genetic Signatures. “The US is the largest, single market for molecular diagnostic tests and represents 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.”
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