The firm is starting a trial that it anticipates will lead to an application for marketing clearance with the US Food and Drug Administration by next year.
The firm noted that its study showed strong performance data, including high sensitivity and high specificity, in providing results direct from blood.
During its earnings call this week, the liquid biopsy firm said it is planning a 10,000-patient trial to test its Lunar assay for colorectal cancer screening.
The British molecular diagnostics firm recently completely a redesign of its point-of-care system, called Q-POC, and is planning to seek a CE-IVD mark for the device later this year.
The BioFire FilmArray Pneumonia panel will be used to optimize clinical trial enrollment for an antibiotic to treat combat carbapenem-resistant A. baumannii infections.
The qPCR assay measures methylation of six genes and could help doctors identify aggressive vs indolent prostate cancer more accurately than PSA.
Following promising data from its Circulating Cell-free Genome Atlas study, the firm decided to pivot its breast cancer trial to support its multi-cancer test.
The company is developing a new gold standard comparator test after it encountered problems with typical culture methods it used in developing a new pneumonia assay.
NX Prenatal and Indiana University School of Medicine are collaborating to develop exosome blood tests for preterm birth risk and preeclampsia.
Celcuity's HER2 assay will be used to assess Puma Bio's Nerlynx and chemotherapy on patients with early-stage triple-negative breast cancer.