Regulatory Approval: Page 3

Qiagen obtains CE Mark for tuberculosis blood test
By LabPulse.com staff writers
Qiagen’s Ipsogen JAK2 RGQ PCR kit and NeuMoDx systems and reagents have already received CE Marks under the new IVDR requirements; the firm has pledged to transition all of its products to meet the new EU IVDR regulations.
February 15, 2023
Bacteria Mycobacterium Tuberculosis Social
New York State Department of Health approves PreciseDx breast cancer LDT
By LabPulse.com staff writers
With the approval, PreciseDx can begin testing patient samples using its PDxBr test in the state of New York through its CLIA-certified laboratory.
February 7, 2023
Breast Cancer 3 D Social
FoundationOne Liquid CDx receives FDA approval for use with Rozlytrek (entrectinib)
By LabPulse.com staff writers
The CDx is indicated for use with patients who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib), a targeted therapy developed by Genentech.
January 4, 2023
Lung Cancer2 Social
Virax Biolabs obtains CE Mark, introduces human papillomavirus test kit
By LabPulse.com staff writers
The HPV test kit covers 18 genotypes of the human papillomavirus, including type 53, which is higher risk and becoming increasingly prevalent.
January 4, 2023
Hpv Infection Social
Foundation Medicine obtains FDA approval for NSCLC CDx
By LabPulse.com staff writers
The blood-based test’s first group approval improves physicians’ ability to identify patients in this population for treatment with certain FDA-approved tyrosine kinase inhibitors, Foundation Medicine said.
December 21, 2022
Fda Button Social
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
By LabPulse.com staff writers
IVDR-compliant versions of both analyzers and corresponding consumables are now available in the majority of EU territories.
November 28, 2022
Lab Diagnostic Analyzer Woman Resized
PerkinElmer nabs first FDA authorization for assay to screen for spinal muscular atrophy in newborns
By LabPulse.com staff writers
The assay may be used by certified laboratories for the simultaneous detection of spinal muscular atrophy and severe combined immunodeficiency in newborns.
November 14, 2022
Baby Bottle Social
AMP update: Roche obtains regulatory approvals for six assays on compact MDx system
By Leo O'Connor
The approvals are part of an overall plan to make the broad menu of tests already running on its high-throughput Cobas 6800/8800 MDx systems also available on the more compact Cobas 5800.
November 7, 2022
Lab Hiv Test Social
Roche to launch compact MDx instrument at AMP meeting, obtains FDA premarket approval for HIV assay
By LabPulse.com staff writers
Both the assay and system will be available in U.S. markets in Q4. Roche will showcase both this week at the Association for Molecular Pathology (AMP) 2022 Annual Meeting.
November 1, 2022
Lab Diagnostic Analyzer Woman Resized
SQI Diagnostics nabs Health Canada approval for IL-6 triage test to detect COVID severity
By LabPulse.com staff writers
By testing for the presence of IL-6, the tool helps identify patients at greatest risk of a severe inflammatory response from a cytokine storm, which is associated with the worst patient outcomes.
October 17, 2022
Lung Illustration Blue
Proscia launches expanded digital pathology platform for primary diagnostic workflows
By LabPulse.com staff writers
The product brings together new features to help laboratory networks transition to 100% digital diagnosis and shift away from microscope-based pathology, the firm said.
October 12, 2022
Pathology Digital Workstation Microscope Social
Thermo Fisher Scientific launches CE-IVD marked panel to detect most common gastrointestinal bacteria
By LabPulse.com staff writers
With results available in about two hours at greater than 98% sensitivity and specificity, the panel compares favorably with the culturing of samples in a lab, which can take up to two weeks, the firm said.
October 10, 2022
Diagnostic Analyzer Lab Pcr
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