Madeleine Johnson

The firm will enter studies this month aimed at obtaining CLIA waiver for its FDA-cleared FebriDx assay to distinguish bacterial from nonbacterial infections.

The firm launched the QiAcuityDx system on Monday and will seek US Food and Drug Administration 510(k) clearance along with a BCR-ABL assay.

The PCR and AI-based method from Dutch microbiology diagnostics developer Inbiome can identify more than 200 bacterial organisms in less than four hours.

The firm will enter clinical trials in November for a combined flu, RSV, and COVID test and expects to debut additional small syndromic panels later.

Global organizations are calling for an increase in diagnostic tests — particularly point-of-care molecular assays — to meet the challenge of a new outbreak.

Though the use of AI in healthcare is increasing exponentially, clinicians and communities need to be involved at all stages to prevent amplifying existing biases.

Bio-Rad is expecting a decline in revenues for the full year due to a slower pace of recovery among customers of its core businesses.

The San Diego-based in vitro diagnostics company plans to reduce its real estate footprint by selling facilities in California and New Jersey.

The firm announced its four-year plan on Monday during an analyst day event held at the New York Stock Exchange.

New systems to directly detect nucleic acids from patient samples are on the horizon, but still fall short of gold standard amplification-based techniques and likely face a difficult regulatory path.