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Adaptive Announces IVDR Certification for clonoSEQ® in European Union
Adaptive Biotechnologies (Nasdaq: ADPT) has announced that its clonoSEQ® test has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union. This makes clonoSEQ the first IVDR-certified test for detecting minimal residual disease (MRD) in patients with lymphoid malignancies. The certification allows for broad use in assessing MRD status and changes in disease burden for B-cell malignancies.
clonoSEQ is widely adopted in patient care and clinical trials, with over 3,700 clinicians using it clinically in the past year and its inclusion in more than 160 active biopharma-sponsored trials. The test is available in several European countries through technology transfer partnerships with major academic laboratories, with additional partnerships expected later in 2024.
clonoSEQ is widely adopted in patient care and clinical trials, with over 3,700 clinicians using it clinically in the past year and its inclusion in more than 160 active biopharma-sponsored trials. The test is available in several European countries through technology transfer partnerships with major academic laboratories, with additional partnerships expected later in 2024.
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