Cellgen Diagnostics and Genomic Testing Cooperative announced a collaboration that promises to provide the pharmaceutical industry with the seamless integration of biomarker discovery, validation, and IVD development.
IVD - News
If Chembio Diagnostics and Perseus Science Group are able to get a test on the market, the two would directly compete against Banyan Biomarkers, a company that received a nod from FDA for a concussion test platform last year.
FDA will continue to require a 510(k) clearance for in vitro diagnostic devices designed to detect the bacteria that causes anthrax.
The Redwood City, CA-based company said it would acquire Bellwether Bio, which is focused on improving oncology patient care through pioneering research into the epigenomic content of cell free DNA.
The patent infringement suit was filed by CareDx and is over the non-invasive monitoring for organ transplant rejection through cell-free DNA analysis.
The diagnostic testing community will be able to use it as a resource for a variety of applications, including assay development, test validation, and quality control.
Product launches, study results, and approvals were signs of a pretty significant week in diagnostics, as FDA, CMS, and CDC formed a task force to make diagnostics rapidly available during public health emergencies.
Influenza and its complications cause as many as 140,000 to 710,000 hospitalizations and 12,000 to 56,000 deaths annually in the U.S.
Indiana University of Medicine researchers said the test can help identify biomarkers in the blood and could actually help in the fight against opioid abuse.
The research behind the development of the test was supported by the National Institute of Allergy and Infectious Diseases, part of NIH.
Biodesix and MRM are the latest diagnostic firms to enter into a partnership geared at the early detection of lung cancer.
In addition, the company said it has received a breakthrough device designation for the test, which predicts amyloid PET scan results in patients.
Day Zero Diagnostics has raised $8.6 million to further develop a sequencing-based rapid diagnostic that identifies, within hours, both the species and the antibiotic resistance profile of a bacterial pathogen.
The Mountain View, CA-based company received a nod from FDA for the MUTYH-Associated Polyposis Genetic Health Risk report.