Clinical Groups Call For 'Me-Too' Pathway For Infectious Disease LDT Approvals
This article was originally published in The Gray Sheet
Executive Summary
A group of infectious disease and clinical virology societies are asking FDA to establish an alternative under the agency's proposed lab-developed test framework for infectious disease test services. Clinical laboratories should be able to use commercial high-risk tests as predicates for ID LDTs so they won't have to go through the costly PMA submissions process.
You may also be interested in...
FDA Plan To Regulate LDTs Includes Long Phase-In, Unmet-Need Exceptions
FDA said its new plan, which can’t be released as a formal draft guidance for another 60 days, would establish a more level playing field between test-kit makers and labs, while being flexible when there is not an FDA-approved alternative to an lab-developed test.
Sage’s Dalzanemdor Prospects In Doubt After First Mid-Stage Readout
Dalzanemdor (SAGE-718) showed no difference from placebo in a Phase II Parkinson’s disease study, raising concerns about readouts later this year in Huntington’s and Alzheimer’s diseases.
Behavioral Health Company Two Chairs Secures $72M In Equity And Debt Infusion
Two Chairs, which uses algorithms to match the right therapists with patients, secured $72m in investment to expand its business.