Gastrointestinal (GI) parasites are a pressing public health issue, affecting both humans and animals. Unfortunately, these diseases often go undiagnosed due to limited awareness among healthcare providers and the lack of available diagnostic tests. In the US, undiagnosed GI cases impact at least 12 million Americans, causing health problems either through new infections or long-lasting ones.
Proper diagnosis requires specific serologic (examination of blood serum) tests that detect antibodies against antigens from whole parasites, which are not commonly available in most clinical labs.
However, this will soon change as molecular diagnostics company Genetic Signatures (ASX: GSS) has submitted an application to the Food and Drug Administration (FDA) for regulatory clearance to market its EasyScreen Gastrointestinal Parasite Detection Kit in the US, aiming to capture a market of 5.5 million tests each year.
In the United States, diagnosing GI infections typically involves using sample culture, microscopy, antigen tests, and specific molecular tests. However, this process is known for being slow, sometimes unreliable, requiring a lot of effort, and can take days to produce results. However, the clinical trial data of GSS’ detection kit has shown that the test could serve as an effective, rapid molecular test that covers the eight most common and clinically relevant GI parasites.
Commenting on commercial opportunities ahead upon attaining FDA approval, Managing Director and CEO of Genetic Signatures John Melki said, “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.”
The EasyScreen kits are currently accessible in Australia, Europe, and Canada. Customers who have integrated these kits for syndromic gastrointestinal screening have experienced quicker results, improved reliability, and more efficient workflows.
The 510(k) submission contains data from 1,500 clinical samples collected at three different locations in the US. The EasyScreen kit identifies several GI pathogens not found in other commercial products. Because there were no existing tests for these specific pathogens, GSS had to create new validation methods for the FDA submission. While this delayed the submission by a few months, it also underscores the scarcity of competing tests in this diagnostic market.
In preparation for the upcoming commercial launch of the EasyScreen kit, pending FDA clearance, GSS has been hiring more sales and support staff, investing in local storage and lab facilities, and raising brand awareness through educational webinars hosted by diagnostic news service 360Dx.
The Company has also gathered input from eight Key Opinion Leaders (KOLs) in the US to better understand lab needs and preferences for GI parasite testing, as well as the appeal of the 3base technology, which is the foundation of the EasyScreen kit. GSS claimed that the KOLs have responded positively to the Company’s molecular solution and unique technology.
After submitting the 510(k) application to the FDA, GSS has started collaborating with selected customer experience sites in the US to assess the EasyScreen kit.
Moving forward, Melki also mentioned that the Company is currently conducting clinical studies to support the FDA 510(k) application for another 3base product. This new product is a molecular syndromic test designed to detect major viral respiratory infections in a single test.
Genetic Signatures is a molecular diagnostics company specialising in its own technology called 3base®. The Company develops and commercialises real-time Polymerase Chain Reaction (PCR) products for detecting infectious diseases, branded as EasyScreen™. This technology allows large hospitals and labs to quickly and accurately screen for various infectious pathogens.
The Company targets large hospitals and labs conducting infectious disease screenings, including antibiotic-resistant bacteria, sexually transmitted infections, meningitis, and mosquito-borne diseases.
For the full year ending in 30 June 2023, GSS recorded $16.93m revenue primarily from sales of non-COVID detection kits. This was a 52% decrease from FY22 revenue of $35.42m. As a result, the Company incurred a Net Loss After Tax (NLAT) of $14.05m for the year, primarily attributable to lower sales volumes during the year and heightened supply chain and operational costs, as well as investments to advance growth in US and Europe.
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