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The rapid lateral flow assay from Lumos Diagnostics distinguishes bacterial and nonbacterial respiratory infections using a drop of blood.
The agency said that the test is unnecessary for the screening of whole blood and blood components that are screened with nucleic acid tests and core antigen tests.
The US Food and Drug Administration granted clearances for infectious disease tests, digital pathology software, and hematology analyzers, among other in vitro diagnostic technologies.
The Determine Antenatal Care Panel is used for the simultaneous detection of infectious diseases that threaten maternal and pediatric health.
The partnership will initially focus on low-abundance biomarkers supporting translational research in Alzheimer's disease.
The company's next-generation sequencing-based test is used to aid the detection of cancers in patients with indeterminate ...
NEW YORK – QuidelOrtho announced Monday an integration deal making fecal biomarker testing from Bühlmann Laboratories available on QuidelOrtho's Vitros system. The Bühlmann fecal tests detect ...
Last week, readers were most interested in a story about an extended collaboration between Personalis and Tempus to include colorectal cancer.
Oncologists were one of the few provider groups to register support for the FDA rule, reflecting the challenge of assessing ...
Investigators compared risk prediction using PathomIQ's platform to molecular test results, evaluating its ability to predict biochemical recurrence in high-risk patients.
The Glasgow, Scotland-based firm's Panaromic Platform uses an infrared spectroscopy-based test with machine learning-developed algorithms to detect signals of cancer.
The San Diego-based firm said that it is transitioning beyond laboratory-developed tests and expanding access to its tests for the detection of early-stage cancers.
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