Announcements

Genetic Signatures Announces Regulatory Approval for Complete Enteric Product Suite in Australia and Europe and secures 3base^TM Patent in USA

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GenomeWeb, the largest online newsroom focused on advanced molecular research tools, has featured Genetic Signatures and 3base™ technology, in an article about the company’s continued global market rollout of their existing and new suite of products. The new 3base™ multiplex PCR tests include an assay for detecting sexually transmitted infections and another that tests for all flaviviruses and alphaviruses. These assays complement Genetic Signatures’ tests already available which include assays for enteric and respiratory infections.  The GenomeWeb article highlighted Genetic Signatures’ recent clinical trial of their new EasyScreen^TM Flavivirus/Alphavirus Detection kit, which was presented at the infectious diseases conference, ECCMID, in April 2017 (Vienna, Austria).  The article also discussed the ongoing global expansion strategy including the progress of regulatory approval in Australia and a CE-IVD marking of a number of products in the coming months.

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Genetic Signatures presents clinical trial results of EasyScreen^TM Flavivirus/Alphavirus detection kit at ECCMID 2017

Genetic Signatures (GSS) launches new EasyScreen^TM  STI detection kit

Half Yearly Report and Accounts- GSS Appendix 4D 31 December 2016

Quarterly Cash Flow & Activities Report – GSS Appendix 4C 31 December 2016

2016 Annual Report

Quarterly Cash Flow & Activities Report – GSS Appendix 4C 30 September 2016

• Results show 100% concordance with traditional and confirmatory methods
• EasyScreen™ Sexually Transmitted Infection (STI) Detection Kit offers testing for an increased number of disease targets compared to traditional workflows
• Preliminary Results to be presented at the NRL molecular diagnostics workshop, which is an annual meeting of opinion leaders from pathology testing laboratories
• Further progress made toward market release of the EasyScreen™ Sexually Transmitted Infection (STI) Detection Kit

Molecular diagnostics company Genetic Signatures Ltd (ASX: GSS) is pleased to announce that the preliminary results of a clinical validation trial of the Company’s EasyScreen™ Sexually Transmitted Infection (STI) Detection Kit will be presented today at the NRL Molecular Diagnostics Workshop in Melbourne, Australia. The presentation, entitled “Evaluation of a new 3Base™ Assay for Screening of Sexually Transmitted Infections” will be given by Dr. Damien Stark of St. Vincent’s Hospital (SydPath).

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 (WHO) reporting that more than 1 million STIs are contracted on a daily basis^[1]. The EasyScreen™ STI Detection Kit was designed to cater for the large addressable STI testing market, estimated to be US $550M in 2017^[2].

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% 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.

“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 that: “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.”

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About Sexually Transmitted Infections: The WHO has reported that each year, there are an estimated 357 million new infections with one of four STIs: chlamydia, gonorrhoea, syphilis and trichomoniasis. More than 500 million people are estimated to have genital infection with herpes simplex virus (HSV) and more than 290 million women have a human papillomavirus (HPV) infection. The majority of STIs have no symptoms or only mild symptoms that may not be recognized as an STI. STIs such as HSV type 2 and syphilis can increase the risk of HIV acquisition. Over 900,000 pregnant women were infected with syphilis resulting in approximately 350,000 adverse birth outcomes including stillbirth in 2012. In some cases, STIs can have serious reproductive health consequences beyond the immediate impact of the infection itself (e.g, infertility or mother-to-child transmission)^[1].

About the EasyScreen™ STI Detection Kit: The STIs detected by the EasyScreen™ STI Detection Kit are Chlamydia trachomatis (Chlamydia), Neisseria gonorrhoeae (Gonorrhoea), Lymphogranuloma venereum (LGV), Mycoplasma Genitalium, Trichomonas vaginalis,  Ureaplasma spp. Candida spp. (Thrush), Mycoplasma hominis, Streptococcus agalactiae (Group B Streptococcus), Treponema pallidum (Syphilis), Herpes Simplex Virus 1 (HSV1) and Herpes Simplex Virus 2 (HSV2).

[1] http://www.who.int/mediacentre/factsheets/fs110/en/

[2] 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