Qiagen gets FDA approval for Ayvakit companion diagnostic test (NYSE:QGEN)

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Waldemarus

Qiagen (NYSE:QGEN) said that it has received FDA approval for its therascreen PDGFRA kit, a companion diagnostic for the gastrointestinal cancer drug Ayvakit.

The diagnostic is used to help identify patients with gastrointestinal stromal tumors, or GIST, who may be eligible for treatment with Ayvakit, also known as avapritinib. The companion diagnostic was co-developed with Blueprint Medicines.

Therascreen PDGFRA is Qiagen’s 12th companion diagnostic to receive FDA approval, according to the company.

The Dutch medtech company is expected to release its quarterly earnings report on Tuesday.