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The firm plans to submit an EUA application for its quantitative Sanger sequencing COVID-19 test, which could run on hundreds of available CE instruments.
Investigators reported on how ctDNA, measured using Natera's patient-specific Signatera assays, corresponded to a patient's disease progression and other biomarkers.
After validating its pathogen detection platform for multiple viruses, the firm aims to initially offer a point-of-care diagnostic testing panel by the third quarter.
Researchers published the most comprehensive data to date showing that Grail's screening approach can detect and distinguish a significant number of cancers.
Droplet digital PCR tests for SARS-CoV-2 can potentially detect the very low viral loads seen in asymptomatic and convalescent cases.
Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.
The firm will be validating the test with collaborators in China, and plans to pursue Emergency Use Authorization both in China and the US.
Directing lab-developed tests through the emergency use authorization process has brought to light reagent supply shortages and other hurdles.
After pilot programs showed patients and physicians are interested in genomics, NorthShore is working on "hardwiring" genetics into routine care.
Aiming to improve patient access to critical drugs and tests, a group of legislators have started a caucus to shore up bipartisan support for personalized medicine.