Category Archives: Latest News

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/

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

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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

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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.”

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Genetic Signatures Limited Completes $14m Capital Raising

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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.

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Clostridium difficile is now the most common cause of health care associated infections in the USA

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A recent publication by Shin, Chaves-Olarte, and Warren has described the global epidemiology of Clostridium difficile infection (CDI) as well as new approaches in management, including fecal microbiota transplantation. The publication cites a 2014 study by Magill SS et al that reported that CDI is the most common cause of health care–associated infections in the United States and accounts for 12% of these infections.

Genetic Signatures has a range of real-time PCR-based products for detection of Clostridium difficile in stool. These products allow rapid detection and are compatible with most real-time PCR instruments. As there is no post-PCR handling required, the potential for environmental contamination is virtually eliminated. Click here for more information.

Abstract:
Clostridium difficile is an anaerobic, Gram-positive, spore-forming, toxin-secreting bacillus that has long been recognized to be the most common etiologic pathogen of antibiotic-associated diarrhea. C. difficile infection (CDI) is now the most common cause of health care–associated infections in the United States and accounts for 12% of these infections (Magill SS et al., N Engl J Med 370:1198–1208, 2014). Among emerging pathogens of public health importance in the United States, CDI has the highest population-based incidence, estimated at 147 per 100,000 (Lessa FC et al., N Engl J Med 372:825–834, 2015). In a report on antimicrobial resistance, C. difficile has been categorized by the Centers for Disease Control and Prevention as one of three “urgent” threats (http://www.cdc.gov/drugresistance/threat-report-2013/). Although C. difficile was first described in the late 1970s, the past decade has seen the emergence of hypertoxigenic strains that have caused increased morbidity and mortality worldwide. Pathogenic strains, host susceptibility, and other regional factors vary and may influence the clinical manifestation and approach to intervention. In this article, we describe the global epidemiology of CDI featuring the different strains in circulation outside of North America and Europe where strain NAP1/027/BI/III had originally gained prominence. The elderly population in health care settings has been disproportionately affected, but emergence of CDI in children and healthy young adults in community settings has, likewise, been reported. New approaches in management, including fecal microbiota transplantation, are discussed.

Access the publication here:  Shin J, Chaves-Olarte E, Warren C. 2016. Clostridium difficile Infection. Microbiol Spectrum 4(3):EI10-0007-2015. doi:10.1128/microbiolspec.EI10-0007-2015.

Genetic Signatures Featured in Recent GenomeWeb Article

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GenomeWeb, the largest online newsroom focused on advanced molecular research tools, recently featured Genetic Signatures in an article about the company’s global expansion strategy. The article highlighted the company’s recent launch of Analyte-Specific Reagents in the US and plans to gain FDA approval for its MDx panels. Also discussed was the company’s novel multiplex PCR technology and overall expansion strategy including the ongoing European market penetration program.

Read the full article here

UCLA to launch Genetic Signatures technology after successful completion of study

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  • UCLA successfully completes Genetic Signatures product trial
  • Study demonstrates GSS 3Base™ technology & products as globally impactful
  • Trial results to be officially published by UCLA

Molecular diagnostics company Genetic Signatures Ltd (ASX: GSS) is pleased to announce that the University of California, Los Angeles (UCLA) has notified the Company that a recent GSS product evaluation was successful and showed improved pathogen detection compared to traditional methods.

“We are very pleased with our study results and look forward to working with Genetic Signatures to focus on the best technologies to enhance patient care,” said Romney Humphries, PhD D(ABMM), Section Chief, Clinical Microbiology UCLA. “We will soon be sharing our results in upcoming publications highlighting the infections that can be missed with traditional methods”

Full Press Release

Genetic Signatures Launches Analyte Specific Reagents in the US

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  • 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/2014/09/Alan-Mertz-Written-Statement-for-21st-Century-Cures-Hearing-2014-09-09.pdf

Global, multibillion-dollar fight against superbugs: “Drs should be encouraged to use Diagnostic Tests”

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19 May 2016 – The Age: Superbugs will kill 10 million people a year by 2050

This recent article published in The Age describes a call to action from Britain’s chancellor, George Osborne, to the finance ministers from around the world, to agree on a common approach to fight the threat of antibiotic-resistant bacteria at the September G20 meeting.

“Britain’s Treasury secretary Jim O’Neill released the results of an 18-month review into antimicrobial resistance, warning that superbugs will kill 10 million people a year by 2050 – more than cancer kills today…

“The most effective work would be to reduce the demand for antibiotics, Lord O’Neill said. This was the only way to “change the game permanently”.

Doctors, and patients, needed to “stop treating antibiotics like sweets”. Instead he said doctors should be encouraged to use diagnostic tests to first prove that a patient genuinely needed an antibiotic, before prescribing it.”

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