21 April 2017
STAT-Dx Unveils New In-Vitro Diagnostic System DiagCORE®
Fully-Integrated, Molecular Diagnostics System Unveiled at ECCMID
First Assay for Acute Respiratory Syndromic Testing
BARCELONA – 21 April, 2017 – STAT-Dx, a company specialising in the development of advanced molecular diagnostic systems, is unveiling DiagCORE®, its fully-integrated platform for multiplex real-time PCR diagnosis, at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), taking place in Vienna from 22 – 25 April.
DiagCORE’s multiplex real-time PCR capability offers the possibility to detect and identify up to 48 molecular targets simultaneously in the same sample, making the system suitable for the most complex assays from any clinical sample type. The system utilises single-use cartridges, and provides answers in about one hour with a total sample handling time of less than one minute.
STAT-Dx’s first assay, the DiagCORE® Respiratory Panel, is a qualitative test intended for use with nasopharyngeal swab samples taken from patients with acute respiratory symptoms. The assay is able to detect and identify up to 22 viral and bacterial pathogens simultaneously.
The Company will soon begin registration trials for DiagCORE® Respiratory Panel with the aim of obtaining a CE Mark in the second half of 2017. Further panels are under development, with a focus on clinical microbiology and infectious disease applications. The Company expects its second assay to be a Gastrointestinal Panel which will be commercially available in 2018.
Jordi Carrera, Chief Executive Officer of STAT-Dx, commented: “We are delighted to be unveiling our DiagCORE® system and first Respiratory Panel at ECCMID. STAT-Dx’s fast, syndromic diagnostic system is set to become a key asset in the infectious diseases diagnostic market, which is rapidly embracing innovative multiplex PCR based technologies. DiagCORE’s simplicity and delivery of fast actionable answers has the potential to greatly improve on clinical and economic outcomes. Furthermore, with low manufacturing costs at the core of our design, we are confident on being able to bring a highly competitive product to the market.”
The Company will be presenting its system at booth #43A.
About Syndromic Testing
Syndromic testing, the ability to test simultaneously for the presence or absence of multiple pathogens which may cause or are associated with clinical syndromes, is becoming increasingly important in laboratories and clinics, offering benefits in patient care, antimicrobial stewardship, infection control, epidemiology and surveillance. STAT-Dx believes that DiagCORE’s syndromic testing capability, as well as its convenience and rapid performance, improves clinical decision making, delivers better patient management and generates significant cost savings to the healthcare system.
About the Respiratory Panel
STAT-Dx’s respiratory panel detects Adenovirus, Bocavirus, Coronaviruses 229E, NKU1, NL63, OC43, human Metapneumovirus A/B, Rhinovirus/Enterovirus, Influenza A, Influenza A subtype H1N1 /2009, Influenza B, Parainfluenza viruses 1-4, Respiratory Syncytial virus A, Respiratory Syncytial virus B, as well as Bordetella pertussis, Legionella pneumophilia, Mycoplasma pneumoniae and Chlamydophila pneumoniae.
Founded in 2010 in Barcelona and backed by leading international healthcare investors, STAT-Dx (formerly STAT-Diagnostica) is focused on the development, manufacturing and commercialisation of ‘Closer to Care’ diagnostic solutions in areas where fast and accurate diagnostic results are crucial such as infectious diseases and critical care. Its DiagCORE® in vitro diagnostic system is a versatile, easy-to-use platform that consolidates molecular and immunoassay techniques in a single device.