This latest approval with Piqray is the seventh authorisation of a therapy with a Qiagen companion diagnostic assay. Credit: QIAGEN.

Qiagen has launched the new therascreen PIK3CA RGQ PCR Kit as a companion diagnostic for the detection of patients who could benefit from treatment with Swiss pharmaceutical company Novartis’ new breast cancer drug, Piqray (alpelisib).

The US Food and Drug Administration (FDA) approved the diagnostic to identify activating mutations in the PIK3CA gene.

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The assay is said to be the first to receive US regulatory approval to facilitate breast cancer treatment decisions using plasma specimens as a liquid biopsy.

It is designed to detect 11 PIK3CA mutations, which are estimated to occur in nearly 40% of hormone receptor-positive (HR) advanced or metastatic breast cancer patients.

The therascreen assay builds on the company’s co-exclusive licence from Johns Hopkins University for PCR-based companion diagnostics based on the PIK3CA gene mutations.

Qiagen Molecular Diagnostics business area senior vice-president and head Thierry Bernard said: “Each year, an estimated 66,500 patients in the US are diagnosed with advanced or metastatic breast cancer.

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“We are making the therascreen PIK3CA Kit available immediately following this FDA approval through leading laboratories in the US as a result of QIAGEN’s Day-One Lab Readiness program for Precision Medicine.”

The company co-developed the therascreen Kit in partnership with Novartis.

Novartis’ Piqray has been approved for use in combination with fulvestrant to treat postmenopausal women, and men, with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

“Each year, an estimated 66,500 patients in the US are diagnosed with advanced or metastatic breast cancer.”

Qiagen currently has master collaboration agreements with more than 25 companies to develop and commercialise companion diagnostic tests for their drug candidates.

This latest approval with Piqray is the seventh FDA authorisation of a therapy with a Qiagen companion diagnostic assay.

Earlier this month, Qiagen partnered with Inovio Pharmaceuticals to create a companion diagnostic to identify patients who are most likely to respond to the drugmaker’s new immunotherapy, VGX-3100.