LDTs
EU Adopts Amendment for IVD Regulation Transition
The IVDR will still come into effect on May 26, 2022, but manufacturers of tests cleared before that date will have more time to achieve compliance under the new regulation.
Some laboratorians expressed concern that last week's guidance is a signal of FDA's plans to regulate LDTs broadly in the future.
Precipio Hematologic Malignancy Test Receives NY State Approval
The Hemescreen test uses proprietary high resolution melt technology and can now be used in labs in New York as a laboratory developed test.
FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies
The FDA said it intends to focus on specific EUA requests, while HHS withdrew a policy directing FDA not to enforce premarket review requirements for LDTs.
The company plans to launch a polygenic risk score, a germline-somatic test platform, and LDT and kitted tests for disease monitoring and therapy selection.