Adaptive Announces IVDR Certification for clonoSEQ® in European Union
Adaptive Biotechnologies Corporation (ADPT)
Last adaptive biotechnologies corporation earnings: 2/26 04:05 pm
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Source: GlobeNewswire
SEATTLE, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that clonoSEQ® has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU). The medical diagnostics field has experienced significant technological advancement in recent years, leading the EU to replace its previous regulatory framework, the In Vitro Diagnostics Directive (IVDD), with a more stringent set of standards for quality and safety, known as IVDR. Adaptive worked with EU notified body BSI to complete the certification process and transition the company’s IVDD CE-marked product, the clonoSEQ Assay B-Cell Reagent Set, to this new regulation. clonoSEQ is now the first and only test to receive IVDR certification for the detection of minimal residual disease (
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ADPT
Earnings
- 2/11/25 - Beat
ADPT
Sec Filings
- 2/14/25 - Form 144
- 2/14/25 - Form SCHEDULE
- 2/13/25 - Form 144
- ADPT's page on the SEC website