Roche wins first cancer blood test approval from FDA
Roche has won approval from the US FDA for its 'liquid biopsy' to test for genetic mutations associated with a type of lung cancer, the first such "cancer blood test" to be approved by the US regulator, frequently seen as the bellwether for regulatory approval across the world. The liquid biopsy, Cobas EGFR Mutation Test, is permitted to be used as a companion diagnostic for Roche's erlotinib cancer drug, which is already on the market. Liquid biopsies are seen as preferable to standard tumour biopsies, as they are much less invasive. Many drug companies are investigating so-called companion diagnostics, devices or tests that allow doctors to prescribe patients drugs on a specific genetic basis. 

NEW YORK (GenomeWeb) – The US Food and Drug Administration today announced it has approved Roche's blood-based cobas EGFR Mutation Test v2 to detect EGFR mutations associated with non-small cell lung cancers.

This is the first blood-based genetic test for NSCLC-related mutations approved by the agency. It can now be used as a companion diagnostic for Genentech's cancer drug Tarceva (erlotinib). Specifically, the detection of exon 19 deletion or exon 21 (L858R) substitution mutations in blood samples aids in selecting patients who may benefit from treatment with the drug.

The test was originally approved in 2013 for use on DNA derived from formalin-fixed, paraffin-embedded tumor tissue from NSCLC patients, and was the first companion diagnostic gauging EGFR mutations to receive a nod from the FDA.

Liquid biopsies "have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement.

Following a negative result, the agency advises doctors perform a tumor biopsy. But a positive liquid biopsy test could be beneficial to a patient who may be too ill or otherwise unable to provide a tumor specimen.