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
The FY 2018 omnibus appropriations bill, passed by Congress in late March, included a little noticed provision that could ultimately bring significant changes to the laboratory industry…
From - Diagnostic Testing & Emerging Technologies
Raw data from direct-to-consumer (DTC) genetic tests have an "alarmingly high" false-positive rate, according to a study published…
From - Diagnostic Testing & Emerging Technologies
The vast majority of sudden infant death syndrome (SIDS) cases are not the result of genetic heart diseases (GHDs) or a single genetic cause…
From - Diagnostic Testing & Emerging Technologies
Researchers have developed the first multiplex array for diagnosis of tickborne diseases, according to a study published online…