FDA Gives Green Light to Roche Cancer Test
The US Food and Drug Administration has given the green light to Roche for its FoundationOne CDx personalised diagnostic cancer test, the Swiss group said Monday.
Roche said the FDA had approved the test helping doctors understand the genetic profile of patients' tumors to enable better-targeted therapies and clinical tests.
"The approval of FoundationOne CDx represents a major advance in the personalisation of cancer care, facilitating access for patients in the US to a comprehensive pan-tumour companion diagnostic that will help identify approved treatment options based on the molecular footprint of each individual’s cancer," said Roche's Chief Medical Officer Sandra Horning, also the firm's head of global product development.
"Our belief is that profiling will increasingly become routine in clinical practice, so we have worked closely with Foundation Medicine to develop an extensive clinically and analytically validated platform that can support both existing and future companion diagnostic needs," Horning said in a statement.
Pharmaceutical companies see development of personally tailored treatment as the way ahead to tackle cancer.