September 28, 2016
Open Briefing interview with CEO John Melki – Capital Raising and Company Outlook
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.
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.
September 27, 2016
Clinical Validation of Genetic Signatures EasyScreen™ Sexual Health Detection Kit Commenced
- 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/
September 23, 2016
Date of 2016 Annual General Meeting of Shareholders (GSS: ASX)
Genetic Signatures Limited (ASX: GSS) advises that its 2016 Annual General Meeting will be held on Tuesday 29 November 2016 at 11.00am (Sydney time).
Shareholders will be advised of further details regarding the 2016 Annual General Meeting in a separate Notice of Meeting, which will be provided to shareholders in October 2016.
September 12, 2016
Genetic Signatures issues first tranche of $14 million share placement
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.”
September 12, 2016
Notice of Extraordinary General Meeting/Proxy Form
Notice is given that the Extraordinary General Meeting of members of Genetic Signatures Limited (Company or Genetic Signatures) will be held as follows:
Date: Thursday, 13 October 2016
Time: 11.00am (AEDT)
Venue: BDO Level 11 1 Margaret Street Sydney NSW 2000
Download the Notice of Extraordinary General Meeting/Proxy Form here
September 2, 2016
Genetic Signatures Limited Completes $14m Capital Raising
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.
August 30, 2016
Preliminary Final Report – GSS Appendix 4E 30 June 2016
July 22, 2016
GSS Non-Deal Roadshow Presentation – July 2016
July 21, 2016
Quarterly Cash Flow & Activities Report – GSS Appendix 4C 30 June 2016
June 17, 2016
Genetic Signatures Launches Analyte Specific Reagents in the US
- Further step towards full product suite commercialisation in the US
- Allows uptake of Genetic Signatures 3base™ technology in up to 11,000 CLIA certified laboratories in the US
- To be officially launched during the American Society of Microbiology conference on June 17, 2016
Sydney, Australia, 17 June, 2016: Molecular diagnostics company Genetic Signatures Ltd (ASX: GSS) will today launch a range of Analyte Specific Reagents (ASRs) in the United States. These ASR products utilise the company’s proprietary 3base™ technology and cover a range of pathogen targets. US Laboratories regulated by the Clinical Laboratory Improvement Act (CLIA) may purchase and use ASRs as building blocks to develop and validate proprietary tests for the diagnosis of infectious diseases. These laboratory-developed tests are commonly used in the US market and are offered in up to 11,000 CLIA certified laboratories1.
The ASR products will be officially launched at the American Society of Microbiology conference, Boston, June 17-20, 2016. Genetic Signatures will be exhibiting and showcasing their full product range to more than 10,000 attendees.
“We know that the market in the US seeks technologically superior products that may be used in laboratory-developed tests.” said Mr. Mike Aicher, President of Genetic Signatures US. “This is the next logical step for Genetic Signatures after FDA listing of our Clinical Concentrator Kit, which we completed in August of 2015.”
“This progressive step in our US market entry strategy brings our proprietary 3Base™ technology to the majority of hospital and commercial laboratories in the US,” said Genetic Signatures’ Chief Executive Officer, John Melki PhD. “We believe that our technologically superior ASRs will be well received by the American market.”
About Analyte Specific Reagents: The US Food and Drug Administration (FDA) defines Analyte Specific Reagents as “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents, which through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.” 21 CFR 864.4020
1http://www.acla.com/wp-content/uploads/sites/3/2014/09/Alan-Mertz-Written-Statement-for-21st-Century-Cures-Hearing-2014-09-09.pdf
