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FDA approves first at-home chlamydia and gonorrhoea sample collection in US
2023-11-17
The US Food and Drug Administration (FDA) has approved LetsGetChecked’s at-home testing system for chlamydia and gonorrhoea.
Roche Hepatitis E Serology Tests Get CE Marking
2023-11-17
Roche announced on Thursday it received CE marking for two serology tests for hepatitis E.
Sansure Obtains CE Mark Under IVDR Certification for Surelite Automated CLIA System
2023-11-16
Sansure Biotech has achieved a milestone in the field of immunodiagnostics, marking significant progress in international strategic expansion. On the evening of November 14, Sansure Biotech announced that its automated chemiluminescence immunoassay (CLIA) systems recently received the EU CE IVDR certification.
Foundation Medicine Announces Collaboration with Pierre Fabre Laboratories to Develop Companion Diagnostics in Non-Small Cell Lung Cancer
2023-11-16
Foundation Medicine, Inc., and Pierre Fabre Laboratories today announced a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC).
50+ Chinese IVD companies reported Q3 earnings
2023-11-15
As of 31 October 2023, over 50 Chinese IVD listed companies have announced their Q3 financial results.
AnchorDx, DiaCarta to collaborate on cancer diagnostics
2023-11-15
Biotech company AnchorDx has entered into a long-term partnership with molecular diagnostics firm DiaCarta to develop and commercialize cancer diagnostic products for the global market.
Agilent Gets FDA Approval of Expanded Use of CDx Assay for Keytruda
2023-11-15
Agilent Technologies on Tuesday said it gained US Food and Drug Administration approval of the firm's PD-L1 companion diagnostic assay for use in identifying gastric or gastroesophageal junction adenocarcinoma patients for a combination treatment with Merck's Keytruda (pembrolizumab) checkpoint inhibitor.
The Annual Report of China IVD Industry 2021 Part II-II Challenges
2023-11-14
China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.
Cue Health Reports Third Quarter 2023 Financial Results
2023-11-14
Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the third quarter 2023.
Natera Reports Third Quarter 2023 Financial Results
2023-11-14
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today reported financial results for the third quarter ended September 30, 2023.
IVD China this week: Roche and Dian Diagnostic, SCIEX and Calibre, BD and Purui Biotech, Kingmed Diagnostics and Gilead, Kingmed Diagnostics and Takeda
2023-11-13
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Hologic Non-COVID Fiscal Q4 Dx Revenues Rise 17 Percent
2023-11-13
Hologic reported after the close of the market Thursday that its non-COVID fiscal fourth quarter organic revenues grew 17 percent compared to one year earlier on a constant currency basis with double-digit organic growth across all its divisions.
ARUP Laboratories Gains IVDR-CE Mark for Hemophilia Gene Therapy CDx
2023-11-13
ARUP Laboratories said Friday its companion diagnostic to help identify which patients are eligible for treatment with a gene therapy for hemophilia A received CE marking under the European Union's In Vitro Diagnostics Regulation (IVDR).
Illumina Reports Financial Results for Third Quarter of Fiscal Year 2023
2023-11-10
Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") today announced its financial results for the third quarter of fiscal year 2023, which include the consolidated financial results for GRAIL.
BD Reports Fourth Quarter and Full Year Fiscal 2023 Financial Results
2023-11-10
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced results for its fourth quarter and full year of fiscal 2023, which ended September 30, 2023.
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