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The Berlin-based company is the first to be designated and more NBs expect they will be designated by year end.

Investigators at the Foundation for Research and Technology - Hellas, a Greek research institute, are coordinating the effort.

Specific Diagnostics said it plans to apply CE marking to the Reveal system next year, followed by submission to the FDA for 510(k) clearance. 

With the significant overhaul of the European regulatory landscape underway, some fear it may disproportionately affect small and medium-sized IVD companies.

 

The company said its APAS Independence platform can process 200 culture plates per hour and automatically remove nonsignificant plates from the workflow. 

The diagnostics company announced it has entered a memorandum of understanding with Orot[+] to expand distribution of Todos' blood tests into Japan. 

The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1. 

The lack of a ready infrastructure has some manufacturers spooked about a regulatory bottleneck as the date for compliance draws closer.

The new guidance is part of MDR and IVDR, which have increased oversight of diagnostics, many of which were self-certified under previous rules.

VALUE-Dx involves six IVD companies and is being heralded by participants as an opportunity for competitors to work together to improve test adoption.

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