- Key step in progress toward clinical validation, regulatory approval, and market release of the EasyScreen™ Sexually Transmitted Infection (STI) Detection Kit
- Next step in Genetic Signatures product range expansion
- Large addressable STI testing market estimated at US$550M globally in 2017
- Preliminary results anticipated Q2 FY17
Molecular diagnostics company Genetic Signatures Ltd (ASX: GSS) is pleased to announce that a trial of the EasyScreen™ Sexually Transmitted Infection (STI) Detection Kit has commenced with a clinical partner. The trial will examine clinical patient specimens and compare the EasyScreen™ results with those obtained via current testing standards.
Sexually Transmitted Infections (STIs) have a significant impact on sexual and reproductive health with the World Health Organisation (WHO) reporting that more than 1 million STIs are contracted on a daily basis.
The EasyScreen™ STI Detection Kit was developed over fifteen months and leverages the company’s proprietary molecular diagnostic (MDx) 3Base™ platform technology. The EasyScreen™ STI Detection Kit can simultaneously identify twelve of the most significant and commonly encountered STIs. The trial data will be used to support full regulatory approvals.
“This is an important step in our EasyScreen™ product range expansion strategy. Clinical validation data will allow us to progress toward market release and regulatory approval for this product.” said Genetic Signatures’ Chief Executive Officer, John Melki PhD. “Our 3base™ technology allowed us to develop a panel that covers a broad range of significant pathogens for genuine STI screening. As many STIs are asymptomatic and require screening for diagnosis, our test will allow clinicians to detect a broad range of STIs with a single molecular diagnostic assay.”
 Source: World Market for Molecular Diagnostics, 5th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas) Kalorama Information, Published: 1/9/2013, page 168