Specialist molecular diagnostics (MDx) company Genetic Signatures Limited (ASX: GSS) has received CE-IVD registration for its 3base EasyScreen STI Genital Pathogen Detection Kit, which can detect 10 of the most commonly encountered sexually transmitted infections (STI’s) simultaneously. CE-IVD allows the kit to be marketed freely in the European Union and the UK.
This is the fifth 3base EasyScreen Detection Kit to attain CE-IVD registration, a significant achievement as we continue to execute on our global expansion strategy. Sexually transmitted infections (STI’s) are a large and growing problem globally, and we are pleased to be able to provide a high throughput and accurate diagnostic solution to improve patient outcomes,” John Melki, Genetic Signatures CEO, said.
“Our company continues to work on new products and enhancing current product offerings even while we meet the substantial demand for our EasyScreen SARS-CoV-2 Detection Kits.”
STI’s can have a significant impact on sexual and reproductive health. There are an estimated one million STI’s contracted daily around the world, and the four most commonly reported infections (Chlamydia, Gonorrhoea, Syphilis and Trichomoniasis) account for approximately 376 million cases per annum1. The global testing market value is estimated to be US$420 million pa just for Chlamydia and Gonorrhoea2, and forecast to grow at 7% p.a.
An application for TGA registration was lodged late last year also, and this clearance is anticipated soon.
