Cepheid’s Xpert Respiratory Panel, a multiplex PCR test for 13 viral and bacterial pathogens, has received IVDR CE marking and will soon ship to CE-mark countries, expanding diagnostic options on existing GeneXpert systems.
The American Cancer Society now recommends routine PSA-based prostate cancer screening every two years for average-risk men ages 50-69, citing new evidence that screening lowers mortality and advanced-stage diagnoses.
Toumy Guettouche, PhD, chief scientific officer at Mercy BioAnalytics and a study co-author, discusses how a blood test measuring proteins on extracellular vesicles detected signs of early-stage ovarian cancer before diagnosis—and what researchers still need to establish before the approach could be used for routine screening.
The agreement covers an ESR1 mutation detection kit for metastatic breast cancer and a DPYD genotyping kit for assessing chemotherapy toxicity risk.
The FDA has cleared Cepheid’s Xpert Hemorrhagic Fever Panel, a multiplex PCR test that detects four hemorrhagic fever viruses and delivers results in about an hour on GeneXpert Dx systems, according to the company.
Contrario Medical's single-use device uses a two-membrane design to prepare motile sperm from semen samples.
The molecular test could help identify patients more likely to respond to abatacept, with early access expected in 2027.
Researchers developed a simplified metabolic health score using routine blood markers to identify people at greater risk of developing cardiometabolic disease.
The patent expands intellectual property coverage for the blood-based assay ahead of its planned commercial launch.
In a study of 229 patients, an AI-based liquid biopsy matched magnetic resonance elastography in identifying patients with fibrosis stages associated with eligibility for approved MASH treatments.
A study of more than 1,100 transplant recipients found that persistent or later-emerging elevations in donor-derived cell-free DNA were associated with greater risks of rejection and graft loss.
The Cystic Fibrosis Base assay has received IVDR accreditation, ensuring high standards for detecting cystic fibrosis mutations.
Tampa General Hospital is the first in the Southeast to implement the MeMed BV host-response test in its emergency workflow, reporting a 33% reduction in cefepime use and 13% fewer hospitalizations, according to hospital-led research.