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FDA Approves Foundation Medicine CDx for Use With Janssen Drug in Prostate Cancer Patients

NEW YORK – Roche subsidiary Foundation Medicine announced on Monday that its FoundationOne CDx test received approval from the US Food and Drug Administration for use as a companion diagnostic for Janssen Biotech's Akeega (niraparib and abiraterone acetate).

The drug, administered in a dual-action tablet, was approved by the FDA to treat adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, Foundation Medicine said in a statement. FoundationOne CDx is a next-generation sequencing-based test that uses a tissue sample to analyze 324 cancer-related genes to detect genomic alterations in a patient's tumor and has more than 30 companion diagnostic indications.

"With such a rapidly evolving therapeutic landscape in prostate cancer, high-quality companion diagnostics are important tools to support oncologists in the development of personalized treatment plans for each unique patient," Mia Levy, Foundation Medicine's chief medical officer, said in a statement, adding that FoundationOne CDx "specifically will help enable broader access to an important new therapy option" in BRCA-mutated metastatic castration-resistant prostate cancer.

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