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Karius Test Gets Breakthrough Device Designation for Infectious Disease Diagnosis

The Karius Test, a diagnostic tool for lung infections in immunocompromised patients, received Breakthrough Device Designation from the FDA.

Consolidation, legislation, new testing types, and a shift to more consumer-driven testing are some clinical laboratory predictions for 2024.

Veracyte and Illumina will develop high-performing molecular tests as decentralized IVD tests on Illumina’s NextSeq 550Dx NGS instrument.

Researchers have developed an electronic device for continuously monitoring the health of transplanted organs in real-time.

Diagnostic tests for an H. pylori infection can be invasive or noninvasive. Noninvasive testing is more cost-effective.