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.

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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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