{"id":62845,"date":"2026-03-26T07:02:20","date_gmt":"2026-03-26T06:02:20","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/invivoscribe-expands-ivdr-portfolio-with-identiclone-dx-igh-assay-certification\/"},"modified":"2026-03-26T07:02:20","modified_gmt":"2026-03-26T06:02:20","slug":"invivoscribe-expands-ivdr-portfolio-with-identiclone-dx-igh-assay-certification","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/invivoscribe-expands-ivdr-portfolio-with-identiclone-dx-igh-assay-certification\/","title":{"rendered":"Invivoscribe\u00ae Expands IVDR Portfolio with IdentiClone\u00ae Dx IGH Assay Certification"},"content":{"rendered":"
\n

\nIdentiClone\u00ae<\/sup> Dx IGH <\/i>is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease.<\/b><\/p>\n

<\/a>
<\/a><\/p>\n

SAN DIEGO–(BUSINESS WIRE)–Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH<\/i> Assay has received In Vitro<\/i> Diagnostic Regulation (IVDR) 2017\/746 Class C certification in the European Union (EU). Commercial availability of the IVDR-certified assay is anticipated by early April 2026.<\/p>\n

\nThe IVDR replaces the former In Vitro<\/i> Diagnostics Directive (IVDD), introducing significantly more stringent requirements for clinical evidence, performance evaluation, traceability, and post-market surveillance. Under IVDR, in vitro<\/i> diagnostic devices are classified according to risk from Class A (lowest risk) to Class D (highest risk). Class C devices, such as IdentiClone Dx IGH<\/i>, are considered high-risk tests that play a critical role in disease diagnosis and patient management.<\/p>\n

\nBSI (Netherlands), an EU-designated Notified Body, granted CE certification for the IdentiClone Dx IGH<\/i> Assay following an independent conformity assessment under the IVDR. This approval marks Invivoscribe\u2019s second successful IVDR certification, underscoring the company\u2019s proven regulatory expertise and long-standing commitment to quality, compliance, and patient safety.<\/p>\n

\n\u201cAchieving IVDR certification for the IdentiClone Dx IGH<\/i> Assay is a significant milestone for Invivoscribe and reflects decades of regulatory rigor, scientific excellence, and dedication to international standards,\u201d said Jason Gerhold, Vice President of Global Regulatory, Quality, and Clinical Affairs at Invivoscribe. \u201cThis certification demonstrates our ability to meet the most stringent regulatory requirements and positions us to continue supporting laboratories and clinicians across the EU with high-quality, compliant diagnostic solutions.\u201d<\/p>\n

\nThe IdentiClone Dx IGH<\/i> Assay is a PCR-based in vitro diagnostic device designed for the capillary electrophoresis-based detection of clonality in immunoglobulin heavy chain (IGH<\/i>) gene rearrangements from peripheral blood specimens. The assay now includes integrated analysis software that automates data processing and interpretation, providing standardized, objective results with transparent reporting and full traceability. It serves as an adjunctive tool in the evaluation of patients suspected of having B-cell lymphoproliferative disorders, in which abnormal proliferation of a single B-cell clone produces a population of cells with identical (clonal) IGH<\/i> gene rearrangements, a defining molecular hallmark of B-cell malignancies.<\/p>\n

\nAbout Invivoscribe<\/b><\/p>\n

\nInvivoscribe is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics\u00ae<\/sup><\/i>. For more than thirty years, Invivoscribe has advanced the quality of healthcare worldwide by delivering high-quality, standardized reagents, diagnostic assays, and bioinformatics solutions that support precision medicine. The company has a proven track record of partnering with pharmaceutical and biotechnology organizations to support clinical trial testing through its global laboratory network in the United States, Germany, Japan, and China, as well as to develop and commercialize companion diagnostics, leveraging deep expertise in regulatory strategy and laboratory services. By offering both distributable diagnostic kits and clinical testing services through its globally located clinical laboratory subsidiaries, LabPMM\u00ae<\/sup>, Invivoscribe is an ideal partner across the full diagnostic lifecycle – from development and clinical trials through regulatory submission and commercialization.<\/p>\n

\nFor more information, please visit www.invivoscribe.com<\/b><\/a>, contact inquiry@invivoscribe.com<\/a><\/b>, or follow Invivoscribe on LinkedIn.<\/p>\n

Contacts<\/b> <\/p>\n

\ninquiry@invivoscribe.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

IdentiClone\u00ae Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. SAN DIEGO–(BUSINESS WIRE)–Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH Assay has received In Vitro Diagnostic Regulation (IVDR) … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62845","6":"format-standard","7":"category-industry"},"yoast_head":"\nInvivoscribe\u00ae Expands IVDR Portfolio with IdentiClone\u00ae Dx IGH Assay Certification - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/invivoscribe-expands-ivdr-portfolio-with-identiclone-dx-igh-assay-certification\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Invivoscribe\u00ae Expands IVDR Portfolio with IdentiClone\u00ae Dx IGH Assay Certification - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"IdentiClone\u00ae Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. 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