Australian molecular diagnostics company Genetic Signatures has received the US Food and Drug Administration (FDA) approval for its EasyScreen Gastrointestinal Parasite Detection Kit.
The FDA approval also includes GS1 automated workflow, which enables both sample extraction, rapid sample processing, and 96-well PCR setup on a single platform.
EasyScreen can identify eight of the most common and clinically relevant gastrointestinal parasites in a single test, representing around 90% of all such infections in the US.
The highly automated test is designed to provide results for all eight targets within 5 hours and provides a broad coverage of the FDA-approved molecular tests.
Genetic Signatures interim CEO Neil Gunn said: “We are very excited to have secured our first FDA clearance for a unique and highly differentiated molecular test based on our proprietary 3base technology.
“This has been a key focus for the Company as the US is the largest single market for molecular diagnostics representing approximately 40% of the global market.
“We believe the unique configuration of our test combined with the significant operational efficiencies and potential impact on patient management will make this an attractive product for laboratories and pathology providers in the US.”
Currently, gastrointestinal parasite testing primarily relies on microscopic examination using O&P testing, which is time-consuming, labour-intensive, and slow to provide a result.
Also, the microscopic examination is associated with variable sensitivity with poor patient compliance across multi-sample protocols.
Genetic Signatures is preparing for a commercial launch of its EasyScreen Gastrointestinal Parasite Detection Kit, by installing instruments and completing training at nine sites.
The customer‑experience sites include hospitals, health departments and corporate pathology providers under a customer-experience initiative.
In addition, Genetic Signatures has already identified the CPT codes that are relevant for providing reimbursement to end users from both public and private payors.
The Australian molecular diagnostics company anticipates the first commercial sale of the test kit in the US within the next 60 to 90 days.
