regulatory approval
Pillar Biosciences Receives FDA Approval for OncoReveal Dx Lung and Colon Cancer Assay
The IVD, intended for use on the Illumina MiSeq Dx, detects somatic mutations in tumor tissue samples to guide the use of anti-EGFR therapy where indicated.
Hologic Receives CE Mark for Molecular Test to Quantify Cytomegalovirus
The assay, which quantifies the human cytomegalovirus viral load in transplant patients, represents a new market opportunity for Hologic's MDx business.
FDA Approves GSK's Jemperli With Ventana CDx for dMMR Endometrial Cancer
The FDA also approved the Ventana MMR RxDx panel as a companion diagnostic to select endometrial cancer patients for treatment with dostarlimab.
Roche Elecsys SARS-CoV-2 Serology Test Receives Health Canada Approval
The test measures the level of antibodies to the spike protein of the virus and can be used to establish immunity and vaccine efficacy.
Guardant Health Receives New York State Approval for Guardant Reveal MRD Test
The assay is Guardant Health’s first commercially available product for clinical management of early-stage tumors and is initially focused on colorectal cancer.