FDA approves Illumina's colorectal cancer diagnostic kit

The Food and Drug Administration on Thursday approved Illumina's next-generation sequencing kit for patients with colorectal cancer.

The kit, used on the Illumina MiSeqDx System, helps clinicians identify which patients are eligible for treatment with Amgen's cancer drug Vectibix.

"The [kit] enables labs to implement an in-house solution for precision oncology and signifies that [next generation sequencing] has reached a milestone as a clinical diagnostic platform to aid therapeutic decision-making in oncology," said Garret Hampton, PhD, Illumina's executive vice president of clinical genomics.

Illumina will launch the kit in the third quarter of 2017.

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