Research & Development
Policy & Regulation
Trends & Finance
Regulatory Approval: Page 2
New York State Department of Health approves PreciseDx breast cancer LDT
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
FoundationOne Liquid CDx receives FDA approval for use with Rozlytrek (entrectinib)
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
Virax Biolabs obtains CE Mark, introduces human papillomavirus test kit
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
Foundation Medicine obtains FDA approval for NSCLC CDx
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
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
IVDR-compliant versions of both analyzers and corresponding consumables are now available in the majority of EU territories.
November 28, 2022
PerkinElmer nabs first FDA authorization for assay to screen for spinal muscular atrophy in newborns
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
AMP update: Roche obtains regulatory approvals for six assays on compact MDx system
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
Roche to launch compact MDx instrument at AMP meeting, obtains FDA premarket approval for HIV assay
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
SQI Diagnostics nabs Health Canada approval for IL-6 triage test to detect COVID severity
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
Proscia launches expanded digital pathology platform for primary diagnostic workflows
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
Thermo Fisher Scientific launches CE-IVD marked panel to detect most common gastrointestinal bacteria
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
Olive Diagnostics receives CE Mark for AI-based urinalysis
Its device detects molecular components in the urine and generates data that are sent to the cloud and can be read by a treating physician.
October 3, 2022
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