FDA clearance
23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test
The firm is now authorized to sell a genetic health report on the HOXB13 marker that indicates risk for hereditary prostate cancer, its third DTC cancer risk report with 510(k) clearance.
FDA Approves Thermo Fisher Scientific Oncomine Dx Assay as CDx for Janssen Lung Cancer Drug
The Oncomine Dx Target Test will be used as a companion diagnostic to identify NSCLC patients whose tumors carry EGFR Exon20-insertion mutations.
Immunexpress Receives FDA 510(k) Clearance for Sepsis Assay
The assay, which runs on the company's Idylla platform, distinguishes sepsis from noninfectious systemic inflammation.
FDA Clears Thermo Fisher Scientific Oncomine Assay as CDx for Bile Duct Cancer Drug
The Oncomine Dx Target Test can now be used to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for ivosidenib.
Invitae Writes off $262.5M Liability Upon Failure to Meet Regulatory Milestone
The company still expects the Stratafide cancer test to achieve FDA approval or clearance, but after March 31, 2022.
Sep 8, 2020
FDA Clears DiaSorin Test for Influenza, RSV
Sep 8, 2020
Roche BK Virus Test Garners FDA Clearance
May 13, 2020