Biomarker-Driven Developments in the Context of the New Regulatory Framework for Companion Diagnostics in the European Union.

The new In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) introduces important changes in the EU legal framework for companion diagnostics (CDx), including a new risk-based classification system for in vitro diagnostic tests (IVDs), a first legal definition for CDx and enhanced involvement of notified bodies in the conformity assessment and certification process of CDx. The IVDR also establishes an important link between the assessment of a CDx and the corresponding medicinal product by requiring the notified body to seek a scientific opinion from the medicines regulator on the suitability of the CDx for use with the concerned medicinal product(s) before issuing an IVD certificate. Whereas the IVDR aims at establishing a robust regulatory framework for IVDs, it is also associated with several challenges, such as insufficient capacity of notified bodies and readiness of manufacturers.

Achieving superior carbon transfer efficiency and pH control using membrane carbonation with a wide range of CO contents for the coccolithophore Emiliania huxleyi.

The economic viability of microalgal-derived products relies on rapid CO transfer in a cost-effective manner. Many industrial gas streams contain concentrated CO that, if converted to useful products, would lower greenhouse gas emissions and valorize the wasted CO. Membrane carbonation (MC) uses non-porous hollow-fiber gas-transfer membranes to deliver CO without bubble formation, which makes it possible to achieve a high carbon-transfer efficiency (CTE).

Radiotherapy in the treatment of multiple myeloma.

Fifty-nine patients with multiple myeloma referred for treatment of painful bony lesions received irradiation to 95 local areas, and 16 of the 59 were irradiated using hemibody techniques. Pain relief was obtained in practically all of the irradiated regions. Most local areas were treated to doses of 3000 cGy in 10 to 15 fractions.