FDA Approves First Companion Diagnostic for HER2 Low Metastatic Breast Cancer

Dr. Shalini Singh, MD, Chief Medical Partner Oncology Network currently serving on the Clinical Development and Medical Affairs leadership team at Roche Diagnostics Solutions discusses the FDA approval of a new indication for Roche’s PATHWAY anti-HER2 (4B5) test to identify metastatic breast cancer patients with low HER2 expression for whom recently FDA approved ENHERTU ® may be considered as a targeted treatment.

Shalini Singh, MD, Chief Medical Partner Oncology Network currently serves on the Clinical Development and Medical Affairs leadership team at Roche Diagnostics Solutions.

At Roche, Shalini’s leadership role and strategic guidance focuses on oncology, pathology tissue diagnostics, digital pathology, translational medicine and cancer immunotherapy. She has extensive experience collaborating with teams in R&D, Business Development, Lifecycle Management and Regulatory Affairs to facilitate in vitro diagnostics product development during phases of feasibility, verification and validation for marketing approval submissions to the U.S. Food & Drug Administration (FDA).

Dr. Singh received her medical training from Government Medical College, Amritsar, India. She completed Residency in Anatomic/Clinical Pathology and a Fellowship in Clinical Molecular Genetics at the University of Arizona, Tucson