In Vitro Diagnostics Ivd Market, By Product (Reagents & Kits, Instruments), By Test Type (Clinical Chemistry, Immunoassay, Hematology, Molecular Diagnostics, Microbiology, Coagulation, Others), By Application (Infectious Diseases, Diabetes, Oncology, Cardiology, Nephrology, Autoimmune Disorders, Others), By End User (Hospitals & Clinics, Diagnostic Laboratories, Academic & Research Institutes, Others), By Geography (North America, Latin America, Europe, Asia Pacific, Middle East & Africa)

Published In : Mar 2024

Code : CMI195

Pages :262

Formats :

Excel and PDF

Industry : Clinical Diagnostic

Key Developments

On March 06, 2024, CleanNA, a Netherlands-based manufacturer of magnetic bead-based nucleic acid extraction kits and systems, introduced its second CE-IVD-certified product. The Clean Quick Viral DNA/RNA (CE-IVD) kit extracts viral DNA and RNA from nasopharyngeal or oropharyngeal swabs that have been maintained in an inactivating viral transport medium.
On February 12, 2024, Roche, a multinational healthcare company, introduced three new coagulation tests for the oral Factor Xa inhibitors apixaban, edoxaban, and rivaroxaban in countries that accept the CE mark. These anticoagulants were added to the World Health Organization's Model List of Essential Medicines in 2019 due to their potential advantages for patients.
On January 04, 2024, HORIBA Medical, a manufacturer of in vitro diagnostic equipment, launched the new HELO 2.0 high throughput automated hematology platform, which is CE-IVDR approved and awaiting U.S. FDA certification. Following the success of HORIBA Medical's prior HELO, this next generation high-end hematology line was developed in collaboration with customers to further improve and meet all of the needs of high throughput fully automated hematology.
In July 2022, DiaCarta Inc., a molecular diagnostics company, announced that the company had received CE-IVD Mark (CE Marking according to the Requirements of European Directive) for its newly developed QuantiVirus SARS-CoV-2 & Flu A/B test. The QuantiVirus SARS-CoV-2 & Flu A/B Detection Test is a real-time PCR test for the qualitative detection of SARS-CoV-2 and influenza virus nucleic acids in nasopharyngeal swabs or saliva from people with suspected COVID-19 and/or flu.
In June 2022, Agilent Technologies Inc., an American analytical instrumentation development and manufacturing company, announced that previously CE-IVD marked instruments, kits and reagents had been approved as IVDR Class A under the new EU IVDR regulation on May 26, 2022. This introduction of Class A IVDR-compliant products ensures that EU laboratories that rely on Agilent IVDR instruments, kits and reagents in their diagnostic workflows can continue to use these products without interruption.