ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
The grants, which include $3 million from the NIH and $1 million from the NSF, will help the company develop point-of-care tests
Most of Invitae's employees will be hired by Labcorp, which expects the deal to add about $275 million in annual revenue
Publishing peer-reviewed studies to tout the economic benefits of medical devices is fairly commonplace, but rare for a laboratory company
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
Recently announced collaboration between Viome and Henry Schein allows dentists to offer sample collection for Viome’s assay to patients
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Partnership between Mindera and PBM aims to optimize treatment matches for the disorder, as some drugs cost nearly six figures annually
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan