FDA Watch: New Test for Esophageal Conditions is Coming to the US
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
From - Laboratory Industry Report
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for…
From - Laboratory Industry Report
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use…
From - Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
From - Laboratory Industry Report
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new…
From - Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…
From - Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…
From - Laboratory Industry Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
From - Laboratory Industry Report
After a slow start to the year, new product business picked up significantly in the past four weeks. Here's a rundown…