FDA Clears Genetic Signatures’ Molecular Diagnostic Solution for Gastrointestinal Parasites
A comprehensive and uniquely differentiated multiplex PCR test for gastrointestinal parasites
Newtown, New South Wales, Australia, 4th Jun 2024 – Genetic Signatures Limited (ASX: GSS), a leader in molecular diagnostic solutions for infectious disease, announces United States (US) Food and Drug Administration (FDA) 510(k) clearance for its EasyScreen™ Gastrointestinal Parasite Detection Kit and GS1 automated workflow. This milestone represents a significant advancement in clinical diagnostics for expanded gastrointestinal (GI) parasite testing, providing healthcare professionals with a powerful, innovative tool for accurate and timely diagnosis.
Each year, over 3.5 billion people worldwide are infected with GI parasites, resulting in over 200,000 deaths and significant health and economic burdens. It is estimated that there are approximately 65 million cases of parasitic GI infections per annum in the US with only 15% presenting to medical professionals. The incidence of gastrointestinal parasites in the US remains a public concern. Local cases are often linked to contaminated water, food or surfaces. Additionally, GI parasites can be acquired during international travel or by intra family transmission, with asymptomatic cases playing a role in spreading infection. In the US, diagnosis primarily relies on microscopy, which is time-consuming, complex, labour intensive, variable in reliability, and heavily reliant on highly trained staff.
Genetic Signatures’ EasyScreen™ Gastrointestinal Parasite Detection Kit is a comprehensive FDA-cleared solution, that enhances accuracy and efficiency in parasite detection. The automated, molecular workflow offer significant advantages for clinical detection of GI parasites. Utilising patented 3base™ technology, this highly sensitive solution can identify eight of the most common and clinically relevant gastrointestinal parasites in a single test, from a single patient sample. This automation addresses the many challenges of microscopic examination, streamlining and simplifying the diagnostic workflow to provide a significant walkaway time advantage, and same-day reporting. This rapid turnaround enables timely and appropriate patient management, significantly improving health outcomes and reducing healthcare costs.
“Genetic Signatures’ gastrointestinal parasite panel advances molecular microbiology by providing rapid diagnostics with increased sensitivity and specificity over routine methods, resulting in improved patient outcomes,” said Lynne S. Garcia, Director, LSG & Associates.
Genetic Signatures’ FDA-cleared assay also offers an alternative to enteric lab-developed tests (LTDs), which have significant cost and complexity associated with development, validation and maintenance.
“With the recent FDA enforcement of LDTs, more and more laboratories will be looking for FDA cleared solutions for everyday laboratory challenges. Gastrointestinal protozoa testing continues to be one of the biggest challenges in large microbiology laboratories. The 510(k) clearance of the Genetic Signatures EasyScreen™ Gastrointestinal Parasite Detection Kit is significant in that it provides a solution for protozoal testing while obviating the need for laboratories to manage and maintain an LDT within the future framework of the FDA.” said Professor Marc Couturier, Medical Director of Parasitology/Fecal Testing, Infectious Disease Antigen Testing, Medical Director over Emerging Public Health Crises, ARUP Laboratories.
“Securing FDA clearance marks a major milestone for Genetic Signatures,” said Neil Gunn, interim CEO, Genetic Signatures. “We are excited to offer patients and customers a new solution to a major health care issue in the US. 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. We have established a highly experienced and dedicated team in North America and are excited to assist laboratories introduce and expand use of 3base™ technology, to help patients who experience gastrointestinal parasitic infections.”
For more information visit www.geneticsignatures.com
Media Contact:
Dr Angela Curtis
Global Marketing Manager
Genetic Signatures
Investor Contact: [email protected]
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Authorisation and Additional Information
This announcement was authorised by the Board of Directors of Genetic Signatures Limited.
About Genetic Signatures Limited: Genetic Signatures is a specialist molecular diagnostics (MDx) company focused on the development and commercialisation of its proprietary platform technology, 3base®. Genetic Signatures designs and manufactures a suite of real-time Polymerase Chain Reaction (PCR) based products for the routine detection of infectious diseases under the EasyScreen™ brand. Genetic Signatures’ proprietary MDx 3base® platform technology provides hospital and pathology laboratories with the ability to screen for a wide array of infectious pathogens, with a high degree of specificity, in a rapid throughput (time-to-result) environment.