PARIS – Being first to market does not mean you have won the game. With competition heating up in a new category of in vitro diagnostics (IVDs) called syndromic testing, that lesson is being refreshed as a new case study takes shape. Based on multiplex polymerase chain reaction (PCR) assays, syndromic testing for infectious diseases in just a few years has captured 45 percent of the $2 billion market segment for molecular diagnostics, according to Grand View Research based in San Francisco. With a projected annual growth rate of 13.3 percent PCR-based molecular diagnostics are...

PARIS – Being first to market does not mean you have won the game. With competition heating up in a new category of in vitro diagnostics (IVDs) called syndromic testing, that lesson is being refreshed as a new case study takes shape.

PARIS – It's almost official. After eight years of hard-fought negotiating, the European Parliament repealed the 30-page Medical Device Directives governing the Conformité Européen certification, or CE Mark, and adopted the 600 pages of the Medical Device Regulation (MDR) and In vitro Diagnostic Medical Devices (IVDR). No one in Europe is celebrating. Though April 5, 2017 was called "an historic day for our industry" by the German Medical Association BVMed, based in Berlin, before it carefully described a potential train wreck the new legislation has put in motion. (See Medical Device Daily, Feb. 27, 2017.)...