FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
From - Diagnostic Testing & Emerging Technologies
Physicians often fail to recommend genetic testing for breast cancer patients at high risk for mutations, according to a research letter published Feb…
From - Diagnostic Testing & Emerging Technologies
Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report…
From - Diagnostic Testing & Emerging Technologies
The case has been made repeatedly over the past few years regarding the need to increase physicians' genomics knowledge. Now, for the first time…
From - Diagnostic Testing & Emerging Technologies
Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used…
From - Diagnostic Testing & Emerging Technologies
The application of pharmacogenomics (PGx) into routine, clinical care remains very limited, despite its potential to improve drug and…