NEW YORK – Infectious disease diagnostics firm Genetic Signatures on Monday said it filed a 510(k) submission with the US Food and Drug Administration for a syndromic enteric protozoa detection kit.
The Australian firm said it is seeking regulatory clearance to market in the US its PCR-based EasyScreen Gastrointestinal Parasite Detection Kit for eight of the most common and clinically relevant gastrointestinal parasites. It said the kit provides a rapid molecular alternative to culture and microscopy, which can be time-consuming, labor-intensive, and sometimes unreliable.
The firm expects the costs of the test will be covered under CPT code 87506, which has a reimbursement rate of $263.
Genetic Signatures' protozoa test kits are already available in Australia, Europe, and Canada, and company officials said in 2020 they planned to expand their operations in the US and seek FDA clearance for a GI parasite detection kit. The 510(k) application is supported by clinical data collected through testing on 1,500 samples at three US sites.
The company said it has been recruiting additional sales and support staff and investing in warehousing and laboratory facilities in anticipation of FDA clearance. It also is conducting clinical studies to support an FDA 510(k) submission in the first half of 2024 for a viral respiratory infection test.
"The US is the largest, single market for molecular diagnostic tests and represents significant opportunity for our EasyScreen Gastrointestinal Parasite Detection Kit," Genetic Signatures Managing Director and CEO John Melki said in a statement. "With a greater range of GI parasite targets provided in this syndromic solution, and the unique advantages of our 3base technology to detect these parasites, it is the ideal product to launch into the US market."