Formal application and written agreement support continued EU market access under the IVDR transitional provisions through December 31, 2028
SAN DIEGO, CA — July 23, 2026 — SeekIn Inc. (“SeekIn”), a leader in next-generation sequencing (NGS)-based diagnostics and multi-cancer early detection (MCED), today announced that it has received a confirmation letter from TÜV SÜD Product Service GmbH (Notified Body 0123) regarding the European Union In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) transitional status of six of its in vitro diagnostic products.
The confirmation letter confirms that TÜV SÜD has received SeekIn’s formal IVDR application in accordance with the first subparagraph of Section 4.3 of Annex VII to the IVDR and has entered into the required written agreement with the company. Subject to SeekIn’s continued compliance with the applicable conditions under Article 110(3c) of the IVDR, the six products are eligible for the transitional period through December 31, 2028.
“This confirmation represents an important milestone in SeekIn’s transition to the IVDR framework and supports the continued availability of our diagnostic solutions in the European market,” said Dr. Mao Mao, Founder and CEO of SeekIn. “We remain committed to rigorous quality standards and are working closely with TÜV SÜD to advance the conformity assessment process for our oncology and molecular diagnostic portfolio, including our multi-cancer early detection and monitoring solutions.”
Products Covered by the Confirmation Letter
The following products are classified as Class C devices for professional use under the IVDR under the IVDR and are covered by the formal application and written agreement:
- OncoSeek® Multi-Cancer Detection Test (protein marker-based multi-cancer early detection)
- SeekInCare® Cancer Detection Kit (multi-omics multi-cancer early detection)
- SeekInCure® Cancer Recurrence Monitoring Kit (recurrence surveillance)
- SeekInClarity® Cancer Treatment Response Monitoring Kit (therapy response monitoring)
- LeukoPrint® Molecular Karyotyping Kit (molecular karyotyping for hematologic malignancies)
- PanCanSeek® Cancer Mutation Detection Kit (NGS-based somatic mutation detection)
About SeekIn
SeekIn Inc. is a biotech company founded in early 2018 in Shenzhen, China, focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since its founding, SeekIn has been committed to providing cutting-edge and cost-effective solutions for cancer early detection, postoperative recurrence monitoring, and treatment response evaluation. SeekIn has also developed novel molecular tests for leukemia patients, and its cancer early detection technology has also been applied in canine cancer detection. With its proprietary technical advances, SeekIn has launched several research and clinical studies in collaboration with top-tier hospitals in China. SeekIn envisions that, by leading a new norm for cancer early detection, the clinical outcomes of mid-/late-stage cancer patients can be reversed, and the cancer mortality rate can be reduced by 15%. For more information about SeekIn's cutting-edge technologies and products, visit www.seekincancer.com.
Regulatory Notice
The Notified Body confirmation letter confirms the status of SeekIn’s formal IVDR application and written agreement for the devices listed above. It does not constitute an IVDR CE certificate or indicate that the final IVDR conformity assessment has been completed. Continued eligibility for the transitional period is subject to the manufacturer’s ongoing compliance with all applicable regulatory conditions under the IVDR and relevant national requirements.