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Foundation Medicine Test Approved by FDA as CDx for Itovebi in Breast Cancer Patients

NEW YORK – Roche subsidiary Foundation Medicine announced Friday that its FoundationOne Liquid CDx assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Genetech's Itovebi (inavolisib) in combination with Pfizer's Ibrance (palbociclib) and fulvestrant for patients with breast cancer.

The test and drug combination are approved for use in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy, Foundation said in a statement.

FoundationOne Liquid CDx uses next-generation sequencing to analyze 324 genes from circulating cell-free DNA isolated from plasma.

"This approval reinforces the importance of testing for PIK3CA mutations at the time of diagnosis to help guide decision-making in the first-line setting for metastatic breast cancer patients," Foundation Chief Medical Officer Mia Levy said in a statement. "Our high quality liquid biopsy companion diagnostic relies on a routine blood draw to identify patients with PIK3CA mutations, enhancing broader access to genomic testing while allowing more patients to benefit from this new best-in-class first-line treatment regimen."