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Svetlana Nikic: How IVDR is affecting cancer research

Svetlana Nikic/precision-oncology-consulting.com

Jul 17, 2024, 21:42

Svetlana Nikic: How IVDR is affecting cancer research

Svetlana Nikic shared a post by Evandro de Azambuja, President of BSMO (The Belgian Society of Medical Oncology) on LinkedIn, adding:

“ESMO – European Society for Medical Oncology is gathering experiences from the European laboratories on how the IVDR (In Vitro Diagnostic Medical Devices Regulation) is affecting their cancer research so this is the time to speak up!

While the initial goal of upcoming IVDR is to ensure better quality, performance and patient safety with regards to in vitro diagnostics, it has faced lots of practical and administrative challenges which are impacting directly European cancer patients’ lives by: .

– not making available access to innovative therapies,
– companies within diagnostic space are faced with additional and significant costs and
– pharmas drug development pipelines might be faced with significant delays and / or alternatively will be moving outside of Europe

At this moment, ESMO is seeking your feedback in order to have a stronger voice in advocating for a better future of cancer research and for the benefit of cancer patients.

Please share your observations by emailing to [email protected].”

Quoting

“How In Vitro Diagnostics Medical Devices Regulation (IVDR) will impact Clinical Trials and cancer research across Europe?

ESMO set out to gather real-world proof that we must act immediately to secure Europe’s role in the vanguard of Oncology Research. Please share your experience about how the IVDR is affecting your research, so that the Society can amplify the community’s voice in advocating for an IVDR which really improves safety and transparency, while facilitating Patient Access, Innovative Therapies, Clinical Trials.

Let us safeguard the future of Cancer Research in Europe for the benefit of Patients With Cancer.”

Sources: Svetlana Nikic/LinkedIn and

Svetlana Nikic, with 18 years of experience in international diagnostic and life sciences, has made contributions to genomics and diagnostics. With a background including roles at Roche Diagnostics and Illumina, she focuses on advancing molecular methods in clinical settings. Svetlana spearheaded initiatives to integrate genomics-based approaches like whole-genome sequencing into oncology routine testing.

Her achievements include establishing an oncology expert network and supporting the introduction of advanced genomic analysis in Swedish leukemia patient care. Svetlana holds advanced degrees in biochemistry, molecular biology, and marketing management, currently pursuing Harvard Medical School courses in Clinical Drug Development and Pharmacology.