Category Archives: Latest News

Genetic Signatures exhibiting at the 16th Asia- Pacific Congress of Clinical Microbiology and Infection (APCCMI)

By | Latest News | No Comments

Genetic Signatures will exhibit at the 16th Asia-Pacific Congress of Clinical Microbiology and Infection (APCCMI) in Melbourne, Australia on 30 November – 3 December 2016.

Genetic Signatures will be exhibiting their EasyScreen products for the detection of infectious diseases, including kits for diagnosing bacterial, viral and protozoan causes of gastroenteritis direct from faeces, and the causes of respiratory infection from swabs in Viral Transport Media (VTM).

Visit Genetic Signatures at Booth 01 at APCCMI 2016 for more information.

Click here to visit the APCCMI website


About APCCMI: APPCMI is an important meeting on clinical microbiology and infectious diseases offering a unique opportunity for clinicians, scientists, researchers, pharmacists and other healthcare professionals working in the Asia Pacific region to meet international experts from various parts of the world. The programme will include presentations on antibiotic stewardship and antimicrobial resistance, infection prevention and control, public health, mycobacterial diseases, virology including HIV, hepatology, parasitology, bacteriology including diagnostics and vaccines.

 

About Genetic Signatures Limited: Genetic Signatures is a specialist molecular diagnostics (MDx) company focused on the development and commercialisation of its proprietary platform technology, 3Base™. Founded in 2001 by the late Dr Geoffrey Grigg, the former Chief of Molecular Biology at CSIRO, Genetic Signatures has released a suite of real-time Polymerase Chain Reaction (PCR) based products for the routine detection of infectious diseases under the EasyScreen™ brand. MDx is a modern technique increasingly used by hospitals and pathology laboratories to detect specific sequences of the genome, the DNA or RNA that define an organism. Genetic Signatures’ proprietary MDx 3Base™ platform technology provides high-volume hospital and pathology laboratories the ability to screen for a wide array of infectious pathogens, with a high degree of specificity, in a rapid throughput (time-to-result) environment. Genetic Signatures’ current target markets are major hospital and pathology laboratories undertaking infectious disease screening. As the spread of infectious diseases around the world continues to grow, the Company plans to launch additional products for the detection of pathogens associated with MRSA, sexual health infections, tuberculosis, meningitis and, antibiotic resistance.

Preliminary Results of EasyScreen™ STI Detection Kit Clinical Validation Trial

By | ASX Announcements, Latest News | No Comments
  • 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 CEO presentation at the 7th Annual Australian Microcap Investment Conference

By | Latest News | No Comments
  • Genetic Signatures to present its global growth strategy for the development and supply of world leading molecular diagnostic products 
  • The largest conference in Australia focused on microcap investment opportunities 
  • Presentations from the CEOs of 24 of Australia’s leading emerging companies 

Molecular Diagnostic (MDx) company Genetic Signatures (ASX: GSS) is pleased to release a copy of the presentation that Chief Executive Officer, John Melki, PhD., will deliver today at the 7th Annual Australian Microcap Investment Conference.

Dr Melki will present on Genetic Signatures’ commercialisation progress, financial results, and achievements to date. The presentation will also detail the Company’s global growth strategy for the sale of world leading solutions for the rapidly growing infectious disease detection market.

Dr Melki said: “2016 was a successful year for Genetic Signatures with record sales revenues and completion of a $15M capital raising. I am looking forward to updating the microcap conference attendees on our progress over the last 12 months and how we are driving shareholder value by accelerating the Company’s growth on a number of fronts.”

Click here to Download the Full Press Release & Presentation

Hear about Genetic Signatures EasyScreen™ Kits at the upcoming NRL Workshop on Molecular Diagnostics

By | Latest News | No Comments

Genetic Signatures EasyScreen™ Pathogen Detection Kits will be featured in two oral presentations at the upcoming NRL Workshop on Molecular Diagnostics in Melbourne, Australia.

The NRL Molecular Workshop is a forum for scientists, regulators, test kit manufacturers and clinicians to unite and discuss current issues and new technologies occurring in the world of molecular pathology for infectious diseases. The aim of this workshop is to focus specifically on molecular techniques involved in detecting infectious pathogens.

The first presentation titled “Impact of automation in the diagnostic laboratory” will be given by Tony Field from Australian Clinical Labs and the second 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.

Click here to visit the conference website for more information

 


About NRL: NRL was established in 1985 as part of the Australian Government’s HIV/AIDS Strategy, to evaluate HIV tests and adjudicate on the interpretation of HIV test results.  Today, NRL remains a not-for-profit scientific organisation that exists for the benefit of the public.  Its overall goal is to support laboratories, in Australia and internationally, that perform testing for the diagnosis and management of human infectious disease. NRL is designated a WHO Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Blood-borne Infections.

 

About Genetic Signatures Limited: Genetic Signatures is a specialist molecular diagnostics (MDx) company focused on the development and commercialisation of its proprietary platform technology, 3Base™. Founded in 2001 by the late Dr Geoffrey Grigg, the former Chief of Molecular Biology at CSIRO, Genetic Signatures has released a suite of real-time Polymerase Chain Reaction (PCR) based products for the routine detection of infectious diseases under the EasyScreen™ brand. MDx is a modern technique increasingly used by hospitals and pathology laboratories to detect specific sequences of the genome, the DNA or RNA that define an organism. Genetic Signatures’ proprietary MDx 3Base™ platform technology provides high-volume hospital and pathology laboratories the ability to screen for a wide array of infectious pathogens, with a high degree of specificity, in a rapid throughput (time-to-result) environment. Genetic Signatures’ current target markets are major hospital and pathology laboratories undertaking infectious disease screening. As the spread of infectious diseases around the world continues to grow, the Company plans to launch additional products for the detection of pathogens associated with MRSA, sexual health infections, tuberculosis, meningitis and, antibiotic resistance.

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

By | ASX Announcements, Latest News | No Comments

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

By | ASX Announcements, Latest News | No Comments
  • 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/

EasyScreen™ Kit shows superior specificity detecting Dientamoeba fragilis in animal faeces

By | Latest News | No Comments

A recent publication in Veterinary Parasitology by Chan et al. “Detection of Dientamoeba fragilis in animal faeces using species-specific real-time PCR assay” has shown that the EasyScreen™ Enteric Protozoan Detection Kit shows superior specificity detecting Dientamoeba fragilis in animal faeces. The EasyScreen™ kit was compared to two previously published PCR methods. The two previously published PCR methods demonstrated cross-reactivity with other trichomonads commonly found in animal samples whereas the EasyScreen™ kit  showed excellent specificity.

It is of interest that this publication suggests that companion animals may play a role in Dientamoeba fragilis transmission, however, the authors note that further investigation is needed into the epidemiology of D. fragilis infection and in particular when identifying animal hosts of D. fragilis.

Abstract
Dientamoeba fragilis is a potentially pathogenic, enteric, protozoan parasite with a worldwide distribution. While clinical case reports and prevalence studies appear regularly in the scientific literature, little attention has been paid to this parasite’s biology, life cycle, host range, and possible transmission routes. Overall, these aspects of Dientamoeba biology remain poorly understood at best. In this study, a total of 420 animal samples, collected from Australia, were surveyed for the presence of Dientamoeba fragilis using PCR. Several PCR assays were evaluated for sensitivity and specificity. Two previously published PCR methods demonstrated cross-reactivity with other trichomonads commonly found in animal samples. Only one assay exhibited excellent specificity. Using this assay D. fragilis was detected from one dog and one cat sample. This is the first report of D. fragilis from these animals and highlights the role companion animals may play in D. fragilis transmission. This study demonstrated that some published D. fragilis molecular assays cross-react with other closely related trichomonads and consequently are not suitable for animal prevalence studies.

Access the publication here

Genetic Signatures issues first tranche of $14 million share placement

By | ASX Announcements, Latest News | No Comments

Molecular diagnostics company Genetic Signatures Limited (ASX:GSS or the Company) is pleased to announce that further to its ASX Announcement of 2nd September 2016, the Board on Thursday 8 September 2016 confirmed the allotment of Tranche 1 of 10,901,161 new shares to be allotted via an institutional placement at an issue price of $0.47, effectively raising $5.1 million.

The Company looks forward to announcing the further approval of the Tranche 2 allotment of 17,906,074 shares to raise a further $8.8 million and a Shareholder Placement Plan (SPP) to raise a further $1 million, which will be considered as resolutions at the coming EGM proposed for Thursday 13 October 2016.

Genetic Signatures’ Chairman, Dr. Nick Samaras, said “I take this opportunity, on behalf of the board, to welcome our new international and domestic shareholders to the register. I also extend our gratitude to existing shareholders who participated in the placement and to those who will participate in the Share Purchase Plan. The proceeds of this oversubscribed placement will enable Genetic Signatures to accelerate its global commercial expansion.”

Click here to read the full release

Genetic Signatures Limited Completes $14m Capital Raising

By | ASX Announcements, Latest News | No Comments

Molecular diagnostics company Genetic Signatures Ltd (ASX: GSS) is pleased to announce that it has successfully completed an institutional placement to raise $14 million through the issue of 29.8 million new shares (Offer).

The proceeds from the Offer will be used for commercial expansion in Australia, the European Union and USA, obtaining further regulatory approvals for Genetic Signatures’ products, continued product development and working capital purposes.

Click here to read the full press release