NEW YORK – Genetic Signatures said Monday that it has ceased development of a molecular respiratory disease test for the US market due to increased competition and a changing market for such assays.
The Australian infectious disease diagnostics firm said it halted development of its real-time PCR-based EasyScreen Essentials Respiratory Detection Kit for the US and no longer intends to submit it to the US Food and Drug Administration for 510(k) clearance.
The firm said it originally planned to develop the syndromic panel for the US market in response to increased molecular testing for respiratory pathogens during the COVID-19 pandemic. Since then, though, several high-throughput fully automated syndromic panels for respiratory diseases have become established, while molecular testing for respiratory pathogens has declined.
"Based on our assessment of the commercial opportunity and the feedback we have had from our potential US customers, we are not sufficiently confident that our US respiratory product will be able to rapidly win market share from the incumbent products in this increasingly competitive market," Genetic Signatures interim CEO Neil Gunn said in a statement.
However, the firm said it remains committed to the sales of its respiratory products in Australia, and it predicts increasing use of those products during the winter.
The company now plans to focus on the imminent US launch of its EasyScreen Gastrointestinal Parasite Detection Kit for the detection of eight common parasites. Last September, it filed a 510(k) submission for the PCR-based syndromic enteric protozoa test.
At the end of last year, Genetic Signatures raised A$15.9 million (US$10.8 million) through a placement and a rights offering.