Summary: The FDA has approved Genetic Signatures’ EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow for marketing and sale in the U.S.


  1. The EasyScreen Kit can identify eight common gastrointestinal parasites in a single test, covering approximately 90% of parasitic infections in the U.S., with results available in around five hours.
  2. The kit’s automated workflow offers a faster, more reliable alternative to traditional microscopic examination methods, which are time-consuming and labor-intensive, improving patient compliance and diagnostic accuracy.
  3. Genetic Signatures has trained and installed instruments at nine customer-experience sites, with positive feedback and anticipated commercial sales within 60-90 days, targeting hospitals, health departments, and corporate pathology providers.

The U.S. Food & Drug Administration (FDA) has cleared Genetic Signatures EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow(1) for marketing and sale in the U.S.

The EasyScreen Kit

Genetic Signatures’ EasyScreen Gastrointestinal Parasite Detection Kit can identify eight of the most common and clinically relevant gastrointestinal parasites in a single test, representing approximately 90%(2) of all gastrointestinal Parasitic infections in the US. Genetic Signatures’ EasyScreen Gastrointestinal Parasite Detection Kit is highly automated and can provide a result for all eighyt targets in approximately 5 hours.

Gastrointestinal Parasite Testing

The current practice for gastrointestinal parasite testing is predominantly microscopic examination using O&P(3) testing, that is time-consuming, labor intensive, slow to provide a result, of variable sensitivity, and frequently has poor patient compliance across multi-sample protocols. It is estimated there are approximately 65 million annual cases of parasitic gastrointestinal infections in the US which result in approximately 5.5 million O&P tests each year.

Genetic Signatures Prepares Launch of the Kit

Genetic Signatures is prepared for the commercial launch of its EasyScreen Gastrointestinal Parasite Detection Kit. The company has installed instruments and completed training at nine customer‑experience sites which span a range of customer groups including hospitals, health departments and corporate pathology providers under a customer-experience program. The company has received positive feedback from these sites and expects some will become the initial commercial customers. Furthermore, the CPT codes which are relevant for providing reimbursement to end users from both public and private payors have been identified. Genetic Signatures expects first commercial sale of the kit in the U.S. within 60 – 90 days of this clearance once the appropriately packaged and labeled product is available and the company’s pathology provider customers have completed their internal technology evaluation and approval process.

“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,” says Neil Gunn, Interim CEO. “This has been a key focus for the company as the U,S. 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 U.S.”


  1. A Genetic Signatures Automated System for Sample Preparation and PCR Set-Up
  2. Advances in Gastrointestinal Parasite Testing: Molecular Parasite Investigations – Genetic Signatures Whitepaper 2024 
  3. Ova & Parasite

Graphic: Genetic Signatures