Roche
Lack of Standardization Across MDx Infectious Disease Tests Could Undermine Pandemic Preparedness
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Poor cross-compatibility may make it difficult to substitute components of automated sample processing and testing workflows in the case of shortages.
Abbott Laboratories, Beckman Coulter, Siemens Healthineers, Roche Gain FDA Clearances in July
Beckman Coulter's DxC 500 AU Clinical Chemistry Analyzer and Siemens Healthineers' Atellica CI Analyzer are among the 510(k) clearances issued in July.
FDA Approves Foundation Medicine CDx for Use With Janssen Drug in Prostate Cancer Patients
The test will be used as a companion diagnostic for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.
Top Five Articles on 360Dx Last Week: ADLM Taking on LDTs; Juno Dx Shuts Down; and More
Last week, readers were most interested in a story about the Association for Diagnostics & Laboratory Medicine's challenge to FDA's plans to regulate LDTs.
Alzheimer's Dx Firms Aim to Take Advantage of Increased Testing Demand Following Leqembi Approval
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Near term, CSF assays and PET imaging will likely remain the methods of choice for evaluating patients for the drug, but blood tests continue to gain traction.