Genetic Signatures

7 Eliza Street
Newtown,  NSW  2042

Australia
https://www.geneticsignatures.com

• Booth: 1463

Genetic Signatures is a specialty molecular diagnostics company focused on the development and commercialization of its proprietary technology, 3base™ to provide hospitals and laboratories the ability to screen for a wide array of pathogens in a high throughput environment. For more information about Genetic Signatures please speak to one of our local representatives.

 Press Releases

• Webinar 1 of 3 - The Burden of Gastrointestinal Parasites and Advances in O (Jun 29, 2024)

  This webinar is the first of a three-part series on Advances in Gastrointestinal Protozoa Testing: Molecular Ova and Parasite Investigations that aims to highlight the prevalence of gastrointestinal (GI) protozoan infection, the significant health and economic burden, and the recent advances in rapid and accurate testing techniques.

  Traditional screening methods for detecting ova and parasites (O&P) have many challenges including longer sample-to-result time and the potential for missed diagnosis. Delayed treatment presents considerable challenges for patients and health professionals alike, with some pathogenic protozoan infections lasting for long periods of time. Recent advances in molecular diagnostics can complement traditional methods, while reducing the time in detecting GI protozoa and coinfection.

  The webinar features two leading experts in parasitology:

  • David Bruckner, ScD
    Professor of Pathology and Laboratory Medicine
    Olive View-UCLA Medical Center
  • Marc Couturier, PhD
    Medical Director, Microbial Immunology, Parasitology and Fecal Testing, and Infectious Disease Rapid Testing
    ARUP Laboratories

  Attendees will learn about:

  • Disease burden and current laboratory testing methodologies for GI protozoa in the US.
  • The challenges faced by clinicians and pathology laboratories using traditional O&P detection methods.
  • Workflow advantages of molecular ova and parasite investigation.
  • Benefits of molecular testing to support laboratory workflow.

• Webinar 2 of 3 - Molecular O&P: A Streamlined Workflow for Ova and Parasite (Jun 29, 2024)

  This webinar is the second of a three-part series on Advances in Gastrointestinal Protozoa Testing.

  The first webinar gave a broad overview of the key parasites causing gastrointestinal disease, traditional diagnostic methods used to detect ova and protozoa, and the benefits of employing a molecular approach.

  In this second live webinar, two leading experts in medical diagnostics, Lynne Garcia and Damien Stark, further discuss the advantages of the molecular detection of gastrointestinal parasites and provide an overview of the molecular diagnostic workflow for pathology laboratories. The workflow from sample to result and reporting is described, and the subsequent clinical support for improved patient management. Clinically relevant protozoan pathogens that cause significant disease and negative health outcomes are discussed including:

  • Giardia spp.
  • Cryptosporidium spp.
  • Cyclospora cayetanensis
  • Entamoeba histolytica
  • Dientamoeba fragilis 
  • Blastocystis spp.
  • Microsporidia

• Webinar 3 of 3 - Molecular O&P: Advances in Gastrointestinal Parasite Testi (Jun 29, 2024)

  This is the final webinar in the three-part educational webinar series on Advances in Gastrointestinal Parasite Testing.

  In this third webinar, three experts in medical diagnostics, Dr. Susan Madison-Antenucci, Prof. Marc Couturier and Dr. Damien Stark describe the benefits of employing a broader syndromic panel to include the detection of the other leading pathogenic parasites causing GI disease, with a focus on Entamoeba, Dientamoeba fragilis, and microsporidia.

  1. D. fragilis and microsporidia, despite their frequent association with human GI disorders and disease, are often overlooked in their role as pathogens, and subsequently excluded from routine testing for suspected GI infections. The speakers will discuss the clinical significance of D. fragilis and microsporidia, and the benefits of including these targets in the broader syndromic molecular detection of GI parasites.

• Press Release - FDA Clears Genetic Signatures’ Molecular Diagnostic Solut (Jun 29, 2024)

  A comprehensive and uniquely differentiated multiplex PCR test for gastrointestinal parasites

  Newtown, New South Wales, Australia, 4^th Jun 2024 – Genetic Signatures Limited (ASX: GSS), a leader in molecular diagnostic solutions for infectious disease, announces United States (US) Food and Drug Administration (FDA) 510(k) clearance for its EasyScreen™ Gastrointestinal Parasite Detection Kit and GS1 automated workflow. This milestone represents a significant advancement in clinical diagnostics for expanded gastrointestinal (GI) parasite testing, providing healthcare professionals with a powerful, innovative tool for accurate and timely diagnosis.

  Each year, over 3.5 billion people worldwide are infected with GI parasites, resulting in over 200,000 deaths and significant health and economic burdens. It is estimated that there are approximately 65 million cases of parasitic GI infections per annum in the US with only 15% presenting to medical professionals. The incidence of gastrointestinal parasites in the US remains a public concern. Local cases are often linked to contaminated water, food or surfaces. Additionally, GI parasites can be acquired during international travel or by intra family transmission, with asymptomatic cases playing a role in spreading infection. In the US, diagnosis primarily relies on microscopy, which is time-consuming, complex, labour intensive, variable in reliability, and heavily reliant on highly trained staff.

   Genetic Signatures’ EasyScreen™ Gastrointestinal Parasite Detection Kit is a comprehensive FDA-cleared solution, that enhances accuracy and efficiency in parasite detection. The automated, molecular workflow offer significant advantages for clinical detection of GI parasites. Utilising patented 3base™ technology, this highly sensitive solution can identify eight of the most common and clinically relevant gastrointestinal parasites in a single test, from a single patient sample. This automation addresses the many challenges of microscopic examination, streamlining and simplifying the diagnostic workflow to provide a significant walkaway time advantage, and same-day reporting. This rapid turnaround enables timely and appropriate patient management, significantly improving health outcomes and reducing healthcare costs.

  “Genetic Signatures’ gastrointestinal parasite panel advances molecular microbiology by providing rapid diagnostics with increased sensitivity and specificity over routine methods, resulting in improved patient outcomes,” said Lynne S. Garcia, Director, LSG & Associates.

  Genetic Signatures’ FDA-cleared assay also offers an alternative to enteric lab-developed tests (LTDs), which have significant cost and complexity associated with development, validation and maintenance.

   “With the recent FDA enforcement of LDTs, more and more laboratories will be looking for FDA cleared solutions for everyday laboratory challenges. Gastrointestinal protozoa testing continues to be one of the biggest challenges in large microbiology laboratories. The 510(k) clearance of the Genetic Signatures EasyScreen™ Gastrointestinal Parasite Detection Kit is significant in that it provides a solution for protozoal testing while obviating the need for laboratories to manage and maintain an LDT within the future framework of the FDA.” said Professor Marc Couturier, Medical Director of Parasitology/Fecal Testing, Infectious Disease Antigen Testing, Medical Director over Emerging Public Health Crises, ARUP Laboratories.

  “Securing FDA clearance marks a major milestone for Genetic Signatures,” said Neil Gunn, interim CEO, Genetic Signatures. “We are excited to offer patients and customers a new solution to a major health care issue in the US. Our unique 3base™ technology offers significant differentiation and advantages for molecular testing of the most challenging samples and gastrointestinal parasites that impact over 60 million patients a year in the US. We have established a highly experienced and dedicated team in North America and are excited to assist laboratories introduce and expand use of 3base™ technology, to help patients who experience gastrointestinal parasitic infections.”

   

  To learn more about the benefits of molecular detection for gastrointestinal parasites, click here.

   

  For more information visit www.geneticsignatures.com

   Media Contact:

  Dr Angela Curtis

  Global Marketing Manager

  Genetic Signatures

  marketing@geneticsignatures.com

  Investor Contact: investors@geneticsignatures.com

   

  –  ENDS –