Molecular diagnostics company Genetic Signatures has finished recruiting for a clinical trial of their 3base EasyScreen Enteric Protozoan Diagnostic Kit.
According to a press release from July 28th, the diagnostic kit will enable users to test for up to eight different types of gastrointestinal parasites simultaneously, with quick and precise results. Using simple, cost-effective methods, parasitic infections will be able to be identified without the need for extensive laboratory facilities or trained personnel.
More than 350 million instances of gastrointestinal infections are reported in the United States each year, with parasites frequently causing serious sickness or even death. Illnesses caused by gastrointestinal parasites place a significant burden on healthcare providers globally and have been identified as the leading cause of death in children under five years old. The new diagnostic kit would allow for rapid and accurate identification of gastrointestinal parasites, proving critical in providing appropriate and timely care for patients.
After the trial, Genetic Signatures has expressed plans to submit for FDA 510(k) clearance by the end of 2022. This would permit the kit to be sold and distributed throughout the United States, setting a new standard for the diagnosis of gastrointestinal parasites.
Read the press release in full here.