Roche launches its first digital PCR for cancer, other diseases

By The Science Advisory Board staff writers

August 24, 2022 -- Diagnostics company Roche has launched its first digital polymerase chain reaction (PCR) system, designed to accurately quantify trace amounts of specific DNA and RNA targets not typically detectable by traditional PCR technology.

Aimed at the areas of oncology and infectious disease, Roche's Digital LightCycler System can find ultra-rare, hard to detect mutations and accurately quantify how much of the target DNA or RNA there is at a molecular level, as well as other high-precision analysis, according to the announcement.

"Understanding the hidden characteristics of serious diseases is fundamental for ensuring that the most effective treatment is selected for each patient," Thomas Schinecker, chief executive officer of Roche Diagnostics, said in a statement. "The Digital LightCycler System will support clinical researchers and laboratories in identifying rare and emerging disease mutations. This can be instrumental in early diagnosis and therapy decisions."

The system, which has an U.S. Food and Drug Administration 510(k) exempt status and will receive a CE Mark, is planned to be available in 15 countries worldwide in 2022 with plans to launch into additional countries.


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