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Molecular Diagnostics
Eurobio Scientific obtains IVDR CE markings for PCR tests
The CE markings enable the firm to market three of its PCR tests as class C in vitro diagnostic medical devices for the detection of infectious diseases.
May 24, 2023
Illumina CEO remains on the board, chairman is voted out
Activist investor Carl Icahn, in a proxy fight, had urged the shareholders to remove the chairman and CEO from the board.
May 26, 2023
Agilent Technologies fiscal Q2 revenues rise 7%; firm trims full-year estimates
Diagnostics and Genomics Group revenues were $362 million, up 1% year-over-year compared to $358 million.
May 24, 2023
Domus Diagnostics gets $2.4M NIH grant to develop at-home molecular test
The award, granted as part of the NIH Rapid Acceleration of Diagnostics (RADx) Tech program, will support accelerated validation and scaling of a testing platform to prepare it for a clinical trial.
May 24, 2023
BPGbio expands agreement with DoD on AI-guided breast cancer diagnostic panel
The diagnostic panel was developed using artificial intelligence to identify patients diagnosed with ER+ breast cancer who do not respond to hormone therapy, to guide caregivers to appropriate treatment options.
May 24, 2023
T2 Biosystems submits FDA 510(k) premarket notification for biothreat panel
The panel is a fully-automated, direct-from-blood test designed to run on the T2 Biosystem’s FDA-cleared T2Dx Instrument and simultaneously detects six pathogens identified as threats by the CDC.
May 23, 2023
A. Menarini launches full automated MDx platform at WorldLab-EuroMedLab
The system, Prime MDx, is an all-in-one, sample-to-result platform designed to allows users to process a variety of sample types through real-time polymerase chain reaction (PCR), the Florence, Italy-based firm said.
May 23, 2023
DNA Script announces broad launch of DNA printing platform
The Syntax platform allows scientists working in their laboratories to synthesize up to 96 highly accurate, ready-to-use DNA oligos with maximum lengths of up to 120 nucleotides in less than 24 hours, DNA Script said.
May 22, 2023
Hologic obtains FDA clearance for multiplex SARS-CoV-2/Flu A/Flu B/RSV assay
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay runs on the fully automated, high-throughput Panther Fusion system, which provides initial results in approximately three hours and can process more than 1,000 tests in 24 hours.
May 19, 2023
Bio-Techne announces interim results on prostate test long-term study
In the prospective, randomized study, researchers are assessing the clinical outcomes of 1,049 men ages 50 and over who have prostate specific antigen (PSA) in the gray zone of uncertain prostate cancer risk.
May 18, 2023
Saliva concussion test in development for female athletes leverages non-coding RNA
A panel that tested for 14 non-coding RNAs differentiated concussed subjects from people who were negative on the head injury assessment and a separate control cohort.
May 19, 2023
At WorldLab-EuroMedLab 2023, Roche to demonstrate next-gen Dx, mass spec for routine testing
The company will unveil the Cobas Mass Spec system prototype, which aims to bring mass spectrometry to routine testing and complement the serum work area testing portfolio.
May 17, 2023
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