Regulatory Approval: Page 2

Exact Sciences gets FDA approval for next-gen Cologuard Plus test
By LabPulse.com staff writers
Exact Sciences has received U.S. Food and Drug Administration (FDA) approval for its next-generation Cologuard Plus colorectal cancer (CRC) screening test.
October 7, 2024
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FDA approves Illumina IVD kit as CDx
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Illumina's TruSight Oncology Comprehensive cancer biomarker IVD kit for use as a companion diagnostic to match patients to two targeted therapies, Bayer's Vitrakvi and Lilly's Retevmo.
August 27, 2024
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Sophia Genetics platform receives CE Mark
By LabPulse.com staff writers
Software firm Sophia Genetics has received the CE Mark under the European Union's In Vitro Diagnostic Regulation for its Sophia DDM platform.
August 15, 2024
Dna Sequencing Data Analysis Social
New laboratory developed tests for colorectal cancer screening get boost from CMS
By Liz Carey
Clinical laboratory test manufacturers aim for estimated 60 million unscreened Americans as CMS meets them with a broad CRC screening test definition and proposed coverage changes in 2025.
July 31, 2024
Colorectal Cancer Social
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
Lung Virus Bacteria Social
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
Alzheimers Tau Tangles Social
Roche's breast cancer CDx receives CE Mark
By LabPulse.com staff writers
Roche has received the CE Mark for the first companion diagnostic (CDx) test to identify patients with HER2-low metastatic breast cancer who may be eligible for treatment with Enhertu.
April 10, 2024
Breast Mammo Social
Bio-Techne receives IVDR certification for chronic myeloid leukemia monitoring test
By LabPulse.com staff writers
Bio-Techne has announced that Asuragen, part of its molecular diagnostics division, has completed class C certification under the new European Union IVDR for its QuantideX qPCR BCR-ABL IS kit for monitoring chronic myeloid leukemia.
March 22, 2024
Blood Test Samples Lab Social
FDA accepts 1st AI-based tool into Istand pilot program
By LabPulse.com staff writers
A mental health assessment tool has become the first AI-powered tool to be accepted into the U.S. Food and Drug Administration's (FDA) Innovative Science and Technology Approaches for New Drugs (Istand) pilot program for advancing drug development.
January 26, 2024
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Sensorion receives clinical trial approval for congenital deafness gene therapy
By LabPulse.com staff writers
French biotech firm Sensorion has received approval to initiate a phase I and II clinical trial in France of SENS-501 (the OTOF-GT program), its gene therapy for gene-mediated hearing impairment.
January 22, 2024
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Health Canada approves Pfizer’s hemophilia gene therapy
By LabPulse.com staff writers
Health Canada, Canada’s regulatory agency, has approved Pfizer's Beqvez (fidanacogene elaparvovec) as a gene therapy treatment for adults with moderately severe to severe hemophilia B.
January 3, 2024
Cell Gene Therapy Dna Social
Regulators to examine Thermo Fisher acquisition of Olink
By LabPulse.com staff writers
Shares of proteomics firm Olink dropped approximately 3% last week following the disclosure by the company that the U.K.’s regulatory body will investigate its pending acquisition by Thermo Fisher.
December 27, 2023
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