Regulatory Approval

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

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

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

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

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

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

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

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

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

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

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

U.K. regulators approve 'world-first' sickle-cell gene therapy

By Matt Limb

U.K. medical regulators have approved a “world-first” gene therapy that aims to cure two blood disorders: sickle cell disease and transfusion-dependent β-thalassemia. They are the first regulatory body to approve the treatment.

November 20, 2023

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