Category Archives: ASX Announcements

Preliminary Results of EasyScreen™ STI Detection Kit Clinical Validation Trial

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  • 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.”

Click here to download the full press release

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

Genetic Signatures Completes Oversubscribed Share Purchase Plan Offer

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Molecular diagnostics company Genetic Signatures Ltd (ASX: GSS) is pleased to announce that it has successfully completed its share purchase plan offer (SPP Offer).

When the share purchase plan (SPP) was announced on 2 September 2016, it was anticipated that the proceeds of the SPP would be capped at $1 million.

The SPP Offer closed on 23 September 2016 with greater than anticipated interest, which has resulted in the Company receiving applications to participate in the SPP from eligible shareholders that exceeded this proposed cap.

Rather than scale-back applications, the Company has determined to accept all valid applications from eligible shareholders. This has resulted in the Company accepting SPP applications for a total of 2,166,962 shares in the amount of $1,018,504.

Complying with the originally anticipated cap would have resulted in the Company either rejecting a small number of valid applications or refunding a small amount to all applicants, depending on how the Company exercised its discretion to scale-back applications.

The new GSS shares are expected to be allotted on 6 October 2016 and holding statements are expected to be despatched to participating shareholders on 7 October 2016. The new GSS shares are expected to be quoted on ASX on 10 October 2016.

Click here to download the full release

Open Briefing interview with CEO John Melki – Capital Raising and Company Outlook

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Molecular diagnostics company Genetic Signatures Ltd (ASX: GSS) has released an Open Briefing interview with CEO Dr. John Melki to update the market on the Company’s recent capital raising and future outlook.

Read the full interview here

 

About Open Briefing: Open Briefing is an online investor communication platform that provides ASX listed companies with a dedicated site for hosting, distributing and archiving important market updates and provides investors with a central resource for increasing their understanding of a company’s fundamentals and strategic direction.

Clinical Validation of Genetic Signatures EasyScreen™ Sexual Health Detection Kit Commenced

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  • 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[1]
  • 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[2].

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.”

Click here to download the full release


 

[1] 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

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