Biomedical technology company Biomerica Inc (Nasdaq: BMRA) announced on Wednesday that it has achieved In Vitro Diagnostic Regulation (IVDR) certification in the European Union for its food intolerance tests targeting Crohn's Disease and Ulcerative Colitis.
This milestone allows the company to sell its products in the EU while adhering to stringent safety and quality standards.
The certified products address the growing demand for non-invasive, personalised therapies for these chronic inflammatory bowel diseases which affect millions globally. Biomerica's food intolerance tests use proprietary technology to identify dietary triggers that may exacerbate inflammation in affected patients.
With this achievement, Biomerica is poised to expand its footprint in the European in vitro diagnostic market. IVDR certification also facilitates easier market access in other international markets that recognise EU standards.
US FDA grants Priority Review to Sobi's sBLA for Gamifant in Still's disease-related MAS
Biomerica secures IVDR certification for food intolerance tests
Devonian files patent for Thykamine as antifibrotic agent
Galderma receives marketing authorisation for Nemluvio in the UK and Switzerland
AlzeCure Pharma secures EUR2.5m EU grant for Alzheimer's drug trial
Galderma secures EU approval for Nemluvio in atopic dermatitis and prurigo nodularis
Aqilion AB sells entire Oncorena Holding AB stake
GenSight Biologics reports positive five-year resultsfor LUMEVOQ gene therapy
NLS Pharmaceutics and Kadimastem plan multi-target approach to diabetes
Bio-Thera Solutions secures EMA acceptance for BAT2506 biosimilar application
Bain Capital to acquire Mitsubishi Tanabe Pharma in USD3.3bn deal
Oxford BioDynamics reports high accuracy for blood-based colorectal cancer test
PhaseV collaborates with Alimentiv to address challenges in GI clinical trials
ValiRx enters into evaluation agreement with Altus Formulation for cancer treatment
Cellipont Bioservices partners with Secretome Therapeutics for cGMP manufacturing