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FoundationOne Test Nabs FDA Approval as CDx for AstraZeneca Breast Cancer Combination Therapy

NEW YORK – Roche subsidiary Foundation Medicine announced on Monday that its FoundationOne CDx assay has been approved by the US Food and Drug Administration as a companion diagnostic for AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) for breast cancer patients.

The drug combination therapy has been approved by the FDA to treatment adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations after progression on at least one endocrine-based therapy regimen in the metastatic setting or recurrence on or within a year of finishing adjuvant therapy, Foundation said in a statement. 

The company noted that FoundationOne CDx will be the first FDA-approved assay to identify this subset of breast cancer patients for treatment with Truqap. According to Foundation, approximately 70 percent of advanced breast cancers are HR-positive, and PI3K-AKT pathway alterations occur in the tumors of up to 50 percent of those HR-positive patients.

Foundation's next-generation sequencing-based test analyzes tissue samples to detect substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements. It also detects genomic signatures, such as microsatellite instability and tumor mutational burden. 

"This companion diagnostic approval adds to the growing utility of Foundation Medicine's high-quality diagnostic test portfolio in treating advanced breast cancer," Troy Schurr, Foundation's chief biopharma business officer, said in a statement.