The US Food and Drug Administration granted clearances for PCR-based infectious disease tests from multiple entities as well as other in vitro diagnostic tests.

The new ruling reverses a jury verdict from four years ago that handed ArcherDx, which no longer exists, $4.7 million in damages.

TBI is a potential new application area for the 8-year-old company, while it continues to commercialize its stroke triage test.

ArteraAI Prostate is authorized for use as a tool to prognosticate long-term outcomes for patients with non-metastatic prostate cancer.

The firm said that it will use the money for working capital and general corporate purposes, and the raise follows a $3.25 million public offering that closed in May.

NEW YORK – The World Health Organization on Monday released an update to its operational handbook on the diagnosis of tuberculosis that provides laboratory personnel, clinicians, ministries of health, ...

Last week, readers were most interested in a story about Diasorin's preparation to enter the point-of-care molecular testing space with a benchtop instrument.

Stakeholders suggested that while the FDA rule is dead, updates to LDT regulation are coming, nonetheless, and the industry ...

Danaher subsidiaries Beckman Coulter, Cepheid, and Leica Biosystems will be working together with external partners to focus ...

The South Korean firm said that its CURECA system offers walkaway PCR testing with 24/7 operation without human intervention ...

The target device includes a portable instrument and 30-minute, $5 assays requiring only small volumes of whole capillary blood.

The laboratory medicine organization is focused on the benefits of using data science within laboratories to more effectively care for patients and track utilization.