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Respiratory bacterial panel gets CE-IVD mark

Feb. 28, 2018—ElitechGroup Molecular Diagnostics launched its Respiratory Bacterial Elite MGB Panel, a high-performance multiplex assay for the diagnosis of …

FDA clears QuickVue Influenza A+B test

Feb. 27, 2018—Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay. The assay allows …

FDA clears Sebia Hydrashift 2/4 daratumumab assay

Feb. 26, 2018—Sebia announced it has received FDA 510(k) clearance for its Hydrashift 2/4 daratumumab assay, intended to be used …

The CAP files brief in support of ACLA MSJ

Feb. 23, 2018—The College of American Pathologists filed an amicus curiae brief in support of the American Clinical Laboratory Association’s …

FDA OKs Janssen’s apalutamide product

Feb. 21, 2018—Janssen Pharmaceuticals announced the FDA approval of Erleada (apalutamide) for the treatment of patients with nonmetastic …

Qiagen to buy Stat-Dx

Feb. 20, 2018—Qiagen has entered into an agreement to acquire Stat-Dx, a developer of molecular diagnostics systems, for $147 million. …

Qiagen launches Therascreen PITX2 test in Europe

Feb. 14, 2018—Qiagen announced the European launch of its novel Therascreen PITX2 RGQ PCR Kit, a clinically validated DNA methylation …

Inspirata buys digital pathology company Omnyx

Feb. 13, 2018—Inspirata, a biotechnology and software company, announced it has acquired Pittsburgh-based Omnyx from GE Healthcare. Omnyx’s flagship digital …

Alcor Scientific’s iSED at the Winter Olympics

Feb. 9, 2018—Alcor Scientific announced its iSED Analyzer will be used by the laboratory at the Korean Medicine Center at …

Advanced Instruments single-sample osmometer

Feb. 8, 2018—Advanced Instruments announced its Osmo1 Single-Sample Micro-Osmometer. It is suited for clinical laboratories that directly draw and test …

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