Grail Sets Fast Pace in Liquid Biopsy with New Milestones
The Menlo Park, CA-based company has been granted Break Through Device Designation by FDA, in addition, the company will share new data from the Circulating Cell-free Genome Atlas, at ASCO.
Medical Device and Diagnostics Industry
IVD
How POC Diagnostics Are Becoming the Norm
Point-of-Care diagnostics are more common place as consumer demand is increasing in healthcare.
Medical Design Excellence Awards 2019 Finalists: Testing and Diagnostic Products and Systems
The following are the finalists for the Testing and Diagnostic Products and Systems category.
10 Deals That Shook up the Diagnostics Industry
MD+DI looks at 10 deals that fundamentally changed the diagnostics industry.
NGS and IVD Manufacturer Team up to Improve Clinical Trials
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.
Collaboration Leads to Blood-Based Concussion and TBI Test
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 Classifies Anthrax Tests as Class II with Controls
FDA will continue to require a 510(k) clearance for in vitro diagnostic devices designed to detect the bacteria that causes anthrax.
Guardant Tests Out M&A Waters with Bellwether Bio
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.
CareDx and Natera Clash in Patent Dispute
The patent infringement suit was filed by CareDx and is over the non-invasive monitoring for organ transplant rejection through cell-free DNA analysis.
First Known Catalog of Somatic Reference Samples for NGS-Based Oncology Tests Now Available
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.
7 Mind-Blowing Moments from HBO's Theranos Documentary
The story of Theranos and its CEO Elizabeth Holmes is wrought with alleged fraud, betrayal, lawsuits, a secret romance, and jumpy houses. Yes, we said jumpy houses. Here are seven times HBO's documentary, The Inventor: Out for Blood in Silicon Valley blew our minds.
Top 10 Patient Safety Concerns in 2019
The ECRI Institute identified these issues as the biggest patient safety concerns in 2019. Can medtech help tackle them?
Could CRISPR Diagnostics Provide a Valuable Weapon in the Fight against Pandemic Flu?
The new diagnostic assay format could provide a means of performing low-cost tests for particular strains of flu at the point of care, but there are challenges to address.
A New Task Force Promises to Cut Through Emergency Diagnostics Clutter
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.
Abbott Offers up Rapid Influenza Diagnostic
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.
A Blood Test for Pain?
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.
