Survey: Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation

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...

Prosecutors Allege Ex-Theranos President ‘Sunny’ Balwani and Elizabeth Holmes Were ‘Partners in Everything, including Their Crimes’

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,...

Hospital-based Clinical Laboratory Scientist is Suing Her Former Employer After Being Fired Due to Long-Haul COVID-19 Illness

Medical laboratory employee alleges healthcare system discriminated based on her medical condition, failed to accommodate her disability, then retaliated and created hostile working conditions What is a clinical laboratory’s obligation when an employee is infected with the SARS-CoV-2 coronavirus and does not make a speedy recovery? Medical laboratory executives should ponder this question now that a California hospital system is being sued by a 33-year laboratory employee who was terminated...

COVID-19 Pandemic Tied to Historically Low Influenza Cases, Leading to Uncertainty about Next Winter’s Flu Vaccine

Clinical laboratories may see increase in flu and COVID-19 specimen processing as people return to pre-pandemic social behaviors, experts predict While SARS-CoV-2 infections continue to ravage many parts of the world, influenza (flu) cases in North America have hit a historic low. As winter approached last year, infectious disease experts warned of a “twindemic” in which the COVID-19 outbreak would combine with seasonal influenza to overwhelm the healthcare system. But this did not happen, and...

FDA Grants CLIA Waiver Allowing First Test for Chlamydia and Gonorrhea to Be Performed at the Point of Care

Federal regulators continue to recognize value of clinical laboratory testing in near-patient settings To help in the diagnosis and management of two sexually-transmitted diseases, another point-of-care diagnostic test will soon be available for use in physician’s offices, urgent care clinics, and other healthcare settings. The federal Food and Drug Administration (FDA) announced it granted a CLIA waiver for the binx health io CT/NG assay, a molecular platform used to detect sexually...
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