Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Genomictree Closing in on South Korea Approval for Bladder Cancer MDx, Aims to Begin US Trials Soon
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Recent study results show that the single-target DNA methylation test performed with a negative predictive value of 97.6 percent.
FDA Clears BioMérieux Gastrointestinal Panel
The panel detects 11 bacteria, viruses, and parasites that cause diarrheal disease with a turnaround time of approximately one hour.
Abbott Receives FDA Clearance for Self-Collected STI Molecular Test
The device is intended for self-collection of samples in home settings and testing in a clinical laboratory.
Roche Lipoprotein (a) Test Receives FDA 510(k) Clearance
The test, which is intended for assessing cardiovascular risk, is the first lipoprotein (a), or Lp(a), test measured in nanomoles per liter to receive FDA clearance.
Doctors and patient advocates supporting pretreatment testing at times challenged FDA and other experts who aren't swayed by available evidence.