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Stat-Dx POC Syndromic Testing Platform, Respiratory MDx Receive CE-IVD Mark

NEW YORK (GenomeWeb) – Molecular diagnostics developer Stat-Dx has received CE-IVD marking on a syndromic testing platform and a respiratory panel, the firm announced today.

The DiagCore system, which was unveiled last year, is fully integrated, cartridge based, and relies on real-time PCR for molecular detection of pathogen nucleic acids. The firm had previously reported that tests on the system take between 30 minutes and 80 minutes to run, and has said it intends to develop DiagCore for decentralized testing settings.

The panel, called Respiratory Panel 1, uses patient nasopharyngeal specimens to detect 21 common bacteria and viruses that can cause respiratory infections. It can help clinicians make decisions about antiviral or antimicrobial treatment, hospital admission, or infection control measures based on the knowledge of the presence or absence of these pathogens, the firm noted.

"This is a key milestone for Stat-Dx and the DiagCore system, one which paves the way for commercialization of the system in Europe, on track for 2018," Stat-Dx CEO Jordi Carrera said in a statement.

The company will present clinical data from evaluation studies of the respiratory panel at the European Congress of Clinical Microbiology and Infectious Diseases conference in April. Stat-Dx also noted that it is developing other syndromic panels focused on clinical microbiology and infectious disease applications, adding that it expects to CE mark a gastrointestinal panel in Q1 2018. The firm has also described immunoassay capabilities for its platform also under development.