The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.
The European Commission is taking steps to ensure that ongoing challenges posed by the implementation of the In Vitro Diagnostic Regulation (IVDR) does not cause unintentional delays to drug clinical trials that are to be run in combination with IVD studies.
Concerns on this front were highlighted in a recent survey by the European industry federation for research-based drug companies, EFPIA. The survey showed that between 82 and 160 drug trials...
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
