Policy and Regulation

Amgen gets FDA approval for small cell lung cancer therapy
By LabPulse.com staff writers
Amgen 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, 2024
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Karius gets FDA breakthrough device designation for infectious disease test
By LabPulse.com staff writers
Karius 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, 2024
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FDA issues warning for Cue Health COVID-19 tests
By LabPulse.com staff writers
The 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, 2024
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Qiagen gets FDA clearance for respiratory syndromic testing panel
By LabPulse.com staff writers
Qiagen 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, 2024
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iHealth gets EUA for combination COVID-19/influenza at-home test
By LabPulse.com staff writers
Diagnostics 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, 2024
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Geneoscopy receives FDA approval for CRC screening test
By LabPulse.com staff writers
Geneoscopy announced that the U.S. Food and Drug Administration (FDA) has approved ColoSense, the firm's noninvasive multitarget stool RNA colorectal cancer (CRC) screening test.
May 7, 2024
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FDA said no to proficiency testing for LDT quality
By Liz Carey
Inferior tests can pass through proficiency testing, among ways PT falls short for test safety and effectiveness for intended purposes.
May 2, 2024
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Leica Biosystems, Sectra receive FDA 510(k) clearance for digital pathology system
By LabPulse.com staff writers
Leica Biosystems has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its Aperio GT 450 DX digital pathology system, in conjunction with Sectra's digital pathology software.
May 2, 2024
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FDA releases LDT final rule
By Liz Carey
The FDA announced its final rule on regulating laboratory developed tests (LDTs), also saying it will adopt targeted enforcement discretion for several categories of IVD LDTs manufactured by labs.
April 29, 2024
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Pillar Biosciences gets FDA approval for NGS solid tumor profiling test
By Matt Limb
Pillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.
April 26, 2024
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Roche, Lilly Alzheimer's blood test granted FDA breakthrough device designation
By LabPulse.com staff writers
The Alzheimer's blood test developed through a collaboration between Roche and Lilly has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA).
April 11, 2024
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European Commission approves Illumina's plan to divest Grail
By LabPulse.com staff writers
The European Commission has approved Illumina's plan to divest multicancer early detection test maker Grail under the European Union Merger Regulation adopted by the EC in October 2023.
April 12, 2024
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