AstraZeneca

The companies have worked together on a number of other cancer-related projects, including a companion diagnostic for the ovarian cancer treatment olaparib.

The company aims to use the methylation technology from its multi-cancer screening assay to detect minimal residual disease in early-stage cancer patients.

The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.

Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.

ArcherDx will develop sequencing-based circulating tumor DNA assays for use in AstraZeneca's recently launched Phase III MERMAID-1 trial of durvalumab (Imfinzi).

The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.

The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.

The collaboration includes setting up a new testing laboratory that will investigate the use of alternative chemical reagents for test kits.

Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.