Dec 14, 2022 | Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Resources, Laboratory Testing, News From Dark Daily
Two former FDA commissioners who support changing oversight of laboratory-developed tests (LDTs) say FDA’s regulatory playbook is ‘outdated’ Congress’ attempts to avoid a government shutdown due to a lack of funding presents a final chance this year for two different clinical laboratory bills to be pushed through. The Verifying Accurate Leading-edge IVCT Development (VALID) Act and Saving Access to Laboratory Services Act (SALSA) could be added to a year-end spending package that will fund...
Oct 31, 2022 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Molecular Diagnostics, Genetic Testing, Whole Gene Sequencing
Regulators and lawmakers are considering proposed changes to CLIA and PAMA involving medical laboratory services Clinical laboratories and pathology groups should monitor a series of federal regulatory developments underway this fall. The proposals and documents will potentially affect how lab managers and staff do their jobs and how much Medicare reimbursement medical laboratories receive for certain diagnostic tests next year. Among the initiatives under consideration are the following:...
Apr 19, 2022 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Testing
Though response was limited in Dark Daily’s poll, the message from respondents was overwhelmingly negative on LDT regulation by the FDA Most respondents to a recent industry survey said that should Food and Drug Administration (FDA) approval be required in the future for laboratory developed tests (LDTs), innovation will suffer. This conclusion echoes what opponents of the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) have argued will happen should that proposed bill...
Apr 11, 2022 | Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, Laboratory Resources, Laboratory Testing
Like Holmes, Balwani faces 12 counts of fraud and conspiracy to commit wire fraud for allegedly misleading investors, patients, and others about blood-testing startup’s technology Clinical laboratory managers and pathologists are buckling up as the next installment of the Theranos story gets underway, this time for the criminal fraud trial of ex-Theranos President and COO Ramesh “Sunny” Balwani. This week, jurors saw text messages between Balwani and his former business partner girlfriend,...
Mar 29, 2022 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Testing, Uncategorized
Survey respondents can give their opinions about the proposed VALID and VITAL acts Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written. An LDT is a proprietary diagnostic test developed and performed by...
