LabPulse.com staff writersKickbackClinical lab to pay $2.5M for rent sham kickback schemeThe lab's agreements with physician practices and providers typically provided for the use of an exam room by lab personnel, as well as for the use of basic equipment.May 17, 2024FDA ClearanceAmgen gets FDA approval for small cell lung cancer therapyAmgen announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved its therapy tarlatamab, to be marketed under the name Imdelltra, for the treatment of extensive-stage small cell lung cancer (ES-SCLC).May 17, 2024Regulatory ApprovalKarius gets FDA breakthrough device designation for infectious disease testKarius announced today that its Karius Test for the diagnosis and management of lung infections in immunocompromised patients has been granted breakthrough device designation from the FDA.May 16, 2024StockT2 Biosystems to sell $8M in stock in private placementT2 Biosystems has announced that it has signed a definitive agreement to sell approximately $8 million in shares and warrants to a group of investors.May 16, 2024Emerging TechnologyBioMarin confirms layoffs and R&D cutsRoctavian, BioMarin's gene therapy for severe hemophilia A, generated $800,000 in net product revenue in the first quarter of 2024.May 15, 2024FDA ClearanceQiagen gets FDA clearance for respiratory syndromic testing panelQiagen announced that it has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx respiratory syndromic testing panel for clinical use.May 14, 2024FDA Warning LetterFDA issues warning for Cue Health COVID-19 testsThe U.S. Food and Drug Administration (FDA) issued a warning to consumers and healthcare providers not to use Cue Health's COVID-19 over-the-counter test and its COVID-19 test intended for point-of-care settings due to an increased risk of false results.May 14, 2024Emerging TechnologyBiomarker extraction through ultrasound shows promise for cancer detectionUltrasound can be used to extract biomarkers from cells for less-invasive cancer detection, new research findings show.May 13, 2024Trends and FinanceNorthwell Health Cancer Institute opens molecular diagnostics laboratoryThe Northwell Health Cancer Institute and its Center for Genomic Medicine have opened a new $3.2 million 2,800-sq-ft molecular diagnostics laboratory in Lake Success, NY.May 13, 2024Emergency Use AuthorizationiHealth gets EUA for combination COVID-19/influenza at-home testDiagnostics developer iHealth Labs has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration for its 3-in-1 COVID-19/Flu A&B Rapid Test Kit for over-the-counter home use.May 10, 2024Page 1 of 343Next PageTop StoriesFDA ClearanceAmgen gets FDA approval for small cell lung cancer therapyAmgen announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved its therapy tarlatamab, to be marketed under the name Imdelltra, for the treatment of extensive-stage small cell lung cancer (ES-SCLC).Artificial IntelligenceBacklog of unresolved medical diagnoses leads to new method for clinical exome reanalysisStockT2 Biosystems to sell $8M in stock in private placementFDA Warning LetterFDA issues warning for Cue Health COVID-19 testsSponsor ContentVisit our Molecular Diagnostics Community
