Genetic Signatures to present results of clinical validation trial

Company News

Molecular diagnostics company Genetic Signatures (ASX:GSS) has announced the preliminary results of a clinical validation trial of its EasyScreen Sexually Transmitted Infection (STI) Detection Kit will be presented at the NRL Molecular Diagnostics Workshop in Melbourne.

The presentation, 'Evaluation of a new 3Base Assay for Screening of Sexually Transmitted Infections', will be given by Dr Damien Stark of St Vincent’s Hospital.

The NRL Molecular Diagnostics Workshop is a leading forum for scientists, regulators, test kit manufacturers and clinicians to meet and discuss current issues and new technologies occurring in the world of molecular pathology for infectious diseases.

Sexually Transmitted Infections (STIs) have a significant impact on sexual and reproductive health with the World Health Organisation reporting that more than 1 million STIs are contracted daily.

According to the company, the EasyScreen STI Detection Kit was designed to cater for the large addressable STI testing market, estimated to be US$550 million in 2017[.

Genetic Signatures said the clinical validation results have shown that the EasyScreen STI Detection Kit allowed the simultaneous identification of 12 of the most significant and commonly encountered STIs with 100 per cent concordance with traditional and confirmatory methods.

"It was shown the assay offered improved accuracy and sensitivity (true positive detection), and additional STI pathogens were identified over existing testing techniques," it said.

“We are very pleased with these results,” said John Melki PhD, CEO of Genetic Signatures. “The rate of STI co-infection is high, and this trial showed that 25.9% of the patient samples had mixed infections (≥2 pathogens detected). These high rates of co- and mixed infections require an assay that can simultaneously screen for a large number of disease targets. As the assay performed so well in this trial we feel confident we have achieved this aim and can now progress toward regulatory approval and market release.”

SydPath is a fully accredited registered pathology laboratory service located within the St Vincent’s Hospital Campus, and an existing customer of the company’s EasyScreen products that screen for a wide range of infectious agents including viral, bacterial and protozoan agents.

SydPath Senior Hospital Scientist Dr Damien Stark commented on the results, saying: “The EasyScreen STI Detection Kit allows simultaneous detection of more STIs than our current methodologies and algorithms. The Genetic Signatures STI test could be easily integrated into our current EasyScreen workflow and would allow us to consolidate our STI screening methods. We look forward to completing the study and publishing these results.”