Darmstadt, August 20, 2026
Blood-based multi-cancer early detection (MCED) test certified under Regulation (EU) 2017/746 (IVDR) by the notified body TÜV Rheinland — confirming compliance with the highest EU requirements for safety, quality and performance for in vitro diagnostics.
- PanTum Detect®, a blood-based multi-cancer early detection (MCED) test built on Zyagnum’s EDIM® technology, has received CE-marking under the EU In Vitro Diagnostic Regulation (IVDR 2017/746).
- Based on information available to Zyagnum, PanTum Detect® is the first multi-cancer early detection (MCED) screening test to be certified under the IVDR.
- Certification confirms that the test meets the IVDR’s stringent requirements for analytical and clinical performance, quality management and ongoing post-market surveillance.
- The test is intended for the screening of asymptomatic adults for the possible presence of solid tumours; it does not replace established diagnostic procedures and requires medical follow-up of abnormal findings.
Darmstadt, August 20, 2026: Zyagnum AG, has received European Union certification for its multi-cancer early detection test PanTum Detect® under the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). The certificate was issued by the notified body TÜV Rheinland LGA Products GmbH. The IVDR replaces the previous In Vitro Diagnostic Directive (IVDD) and sets markedly higher standards for the safety, quality and performance of diagnostic tests placed on the EU market.
About PanTum Detect®
PanTum Detect® is a blood-based in vitro diagnostic test for multi-cancer early detection (MCED). It is based on Zyagnum’s EDIM® (Epitope Detection in Monocytes) technology, which uses the body’s own immune cells for early biomarker detection: when macrophages phagocytose degenerated tumour cells, they take up the tumour-associated biomarkers Apo10 (DNaseX) and TKTL1. Detecting these biomarkers in macrophages — identified via the surface markers CD14 and CD16 — can indicate the possible presence of a solid tumour. Abnormal findings do not constitute a diagnosis and require further diagnostic investigation.
A higher standard for In Vitro Diagnostics
The In Vitro Diagnostic Regulation (EU) 2017/746 introduces a risk-based classification system (Classes A to D), a more in-depth involvement of notified bodies in the conformity assessment, and stricter requirements for technical documentation and for the demonstration of analytical and clinical performance. Manufacturers must also meet extensive data-collection and assessment obligations as part of ongoing post-market surveillance. For users and treating clinicians, IVDR certification means that the product meets these regulatory requirements within the assessed scope of application and remains under continuous surveillance.
Market context
Internationally, the multi-cancer early detection field is gaining regulatory and reimbursement attention. In the United States, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act entered into force on 3 February 2026, creating a framework for Medicare reimbursement of FDA-approved MCED tests from 2028. This concerns the US market, presupposes FDA approval, and is independent of the EU conformity assessment described above.
About Zyagnum AG
Zyagnum AG is a German Biotechnology company based in Darmstadt, Germany. The company develops In vitro diagnostics based on its EDIM® technology, including the multi-cancer early detection test PanTum Detect®.
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