New 4-in-1 Blood Donor Screening Assay Targets HIV, Hepatitis B, C, and E in a Single Workflow
The cobas MPX-E assay is now available in CE-mark accepting countries, offering labs a scalable, automated solution for multiplex nucleic acid testing.
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Roche Receives CE Mark for PCR Test Targeting Bacterial Vaginosis and Candida Vaginitis
The cobas BV/CV assay aims to improve diagnostic accuracy over traditional microscopy and pH testing methods for symptomatic patients.
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Labcorp Partners with Roche to Expand Digital Pathology Capabilities
The collaboration will deploy FDA-cleared slide scanners across anatomic pathology services to support AI integration and address pathologist shortage.
Roche Shares Alzheimer’s Drug and Diagnostic Advances at AAIC 2025
At the Alzheimer’s Association International Conference, Roche shared new data on its investigational antibody trontinemab and its Elecsys pTau217 blood test.
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Blood-Based Biomarkers Are Advancing Alzheimer’s Testing
Blood-based biomarker tests are revolutionizing Alzheimer’s diagnostic testing and management of Alzheimer’s disease.
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SeqOnce Biosciences Adds RT-qPCR Measles Panel
SeqOnce has launched Measles Panel A, a new RT-qPCR assay designed to detect all known measles genotypes—including the D8 genotype.
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Should Labs Add Lp(a) Testing to Their Menus?
Lipoprotein(a), or Lp(a), is a genetically determined and under-recognized cardiovascular disease risk factor.
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Access Medical Labs Transitions to Roche Diagnostics
Access Medical Labs has fully transitioned to Roche Diagnostics equipment in under 30 days, increasing testing speed, capacity & efficiency.
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Roche Receives FDA Nod for Lung Cancer Companion Diagnostic
The FDA has approved Roche’s VENTANA MET (SP44) RxDx Assay, the first companion diagnostic for lung cancer.
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PRO-C3 Launched by Roche Diagnostics on cobas Analyzers
Nordic Bioscience’s PRO-C3 test, now launched globally by Roche Diagnostics on cobas analyzers, offers a way to assess liver fibrosis.
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Breakthrough Device Designation Granted for Roche’s VENTANA TROP2 RxDx Device
Roche’s VENTANA TROP2 RxDx Device, a computational companion diagnostic, has received FDA Breakthrough Device Designation.
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HPV Specimen Self-Collection for Cervical Cancer Screening Introduced by Quest
Quest Diagnostics has introduced a self-collection option for HPV screening, improving access to cervical cancer prevention.
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Prognostic Test for Preeclampsia Receives FDA 510(k) Clearance
Roche’s Elecsys sFlt-1/PlGF test received FDA clearance, providing a prognostic way to help ID pregnant women at risk of severe preeclampsia.
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HER2-ultralow Metastatic Breast Cancer Companion Diagnostic Approved by FDA
Roche’s PATHWAY anti-HER2/neu (4B5) test has received FDA approval to ID patients with HR-positive, HER2-ultralow metastatic breast cancer.
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Roche Lp(a) Test Gets FDA Clearance for Cardiovascular Risk Assessment
Roche’s Tina-quant Lp(a) Gen.2 Molarity assay received FDA 510(k) clearance, supporting more precise cardiovascular risk assessment.
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FDA Clears Roche Point-of-Care STI Tests
The FDA granted 510(k) clearance for Roche STI multiplex panels, enabling rapid diagnosis of chlamydia, gonorrhea, and Mycoplasma genitalium.
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Roche Gets FDA Clearance for Highly Sensitive B-cell Lymphoma Test
A new test for Roche received FDA clearance as a sensitive diagnostic tool to differentiate B-cell lymphomas for improved diagnosis.
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Roche’s Digital Pathology System Gets New FDA Clearance for High-Volume Slide Scanner
Roche’s Digital Pathology Dx platform received additional FDA clearance, now incorporating the VENTANA DP 600 slide scanner.
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