Regulatory Approval

FDA reissues EUA for Janssen COVID-19 vaccine, includes warning about risks of myocarditis, pericarditis

Specifically, the warning states that reports of adverse events after use of the vaccine under emergency use authorization (EUA) suggest increased risks of myocarditis and pericarditis, particularly from zero through seven days following vaccination.

March 14, 2023

Becton Dickinson HPV assay FDA approved with BD SurePath, Hologic ThinPrep Pap tests

The BD Onclarity HPV Assay individually tests for an extended set of HPV types, including HPV 31, which poses a higher risk for causing cervical precancer than HPV 18, Becton Dickinson said.

February 21, 2023

Qiagen obtains CE Mark for tuberculosis blood test

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

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

Most Popular

Genetic causes identified for three rare diseases

Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease

SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests

Duke University researchers discover biomarkers may identify early pancreatic cancer risk

Werfen completes $2B acquisition of Immucor, expands presence in specialized diagnostics

Chembio CEO urges stockholders to tender remaining shares as deadline is extended for acquisition

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

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