Early-Stage Allegro Diagnostics Prepares For Gene Array Market Entry
This article was originally published in The Gray Sheet
Executive Summary
Emerging genetic test firm Allegro Diagnostics is a small fish poised to enter uncertain waters, but the lack of concrete guidelines on FDA regulation of in vitro diagnostic multivariate index assays (IVDMIA) isn't discouraging the company from seeking market entry
You may also be interested in...
FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?
It looks increasingly likely that FDA will play a larger role in genetic test oversight, though policymakers may soon have to decide just how much more the agency can and should do
FDA Takes Second Stab At Multivariate Diagnostic Oversight Guidelines
FDA cautiously moved ahead with its controversial plan to actively regulate certain laboratory-developed tests with the release of a revised 1draft guidance document July 24
Parkinson’s Results Further Sweeten AbbVie’s Acquisition of Cerevel
Cerevel, which AbbVie is spending $8.7bn to acquire, unveiled topline results from the TEMPO-3 study of tavapadon, which an analyst said represents potentially a $1bn opportunity.