Genetic Signatures announced it has completed recruitment for the clinical trial of their 3base® EasyScreenTM Enteric Protozoan Diagnostic Kit in the United States (U.S). This is an essential step to support an application to the Food and Drug Administration (FDA), with submission of a 510(k) application planned during the 4th quarter of CY2022. Once cleared, Genetic Signatures will market this unique syndromic PCR test to the U.S. market.

Genetic Signatures' EasyScreenTM Enteric Protozoan Diagnostic Kit uses the Company's proprietary 3base® technology to analyse the genetic profiles of protozoan pathogens. This allows, in a single sample, the rapid and accurate detection of up to eight species of clinically relevant gastrointestinal parasites. Results from EasyScreenTM tests are available within hours, compared with days or weeks for culture-based methods, and are typically able to identify more infections than traditional methods.

To support Genetic Signatures' 510(k) application, the FDA required the Company to provide data from 1,500 clinical samples collected across three different sites in the U.S. Due to the innovative test design and broad content the samples will be analysed for comparative purposes using commercially available tests where available or with in-house developed validated comparative tests, where no commercially available predicate exists. Once completed, Genetic Signatures anticipates an FDA 510(k) application for its EasyScreenTM Enteric Protozoan Diagnostic Kit to be submitted during the 4th quarter CY2022, after which the FDA will review the application. The FDA has a goal of responding with a decision 90 days from submission.