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PCR
FDA 510(k), CLIA waiver may boost Roche STI tests
By
LabPulse.com staff writers
Roche has been granted 510(k) clearance with a CLIA waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels.
January 22, 2025
Quest to provide services for Mainz Biomed CRC test clinical trials
By
LabPulse.com staff writers
Mainz Biomed has made an agreement with Quest Diagnostics in which Quest will support the commercialization of Mainz Biomed’s next-generation ColoAlert colorectal cancer (CRC) screening test.
December 19, 2024
Labcorp launches H5N1 avian flu test in the U.S.
By
LabPulse.com staff writers
Labcorp has launched its new molecular diagnostic test for patients suspected of infection with the H5N1 virus responsible for the current outbreak of H5 avian flu.
December 19, 2024
BioMĂ©rieux's Biofire tropical fever panel gets special 510(k) clearance
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted special 510(k) clearance to BioMĂ©rieux's syndromic tropical fever panel, developed in conjunction with U.S. government agencies.
December 9, 2024
Devyser gets IVDR approval for fetal RHD test
By
LabPulse.com staff writers
Devyser Diagnostics has received In Vitro Diagnostic Regulation (IVDR) certification for its noninvasive fetal rhesus D (RHD) screening test.
December 2, 2024
Precision for Medicine partners with Agena Bioscience to fill NGS testing gaps
By
LabPulse.com staff writers
Partnership addresses insufficient sample quality in next-generation sequencing (NGS) testing.
November 20, 2024
Qiagen receives FDA clearance for respiratory mini-panel
By
LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Qiagen's respiratory mini-panel, which is designed to aid in the diagnosis of five respiratory pathogens, for clinical use.
October 29, 2024
Roche launches diagnostic test for 12 respiratory viruses
By
LabPulse.com staff writers
Roche Diagnostics has launched its first test using its new high-throughput technology that enables users of Roche's Cobas analyzers to simultaneously test for 12 respiratory viruses.
September 26, 2024
CDC adds commercial lab contracts for infectious disease, bird flu testing
By
Liz Carey
Clinical laboratories incentivized to develop diagnostic tests earlier.
September 17, 2024
Seegene, Springer Nature launch PCR innovation program
By
LabPulse.com staff writers
Molecular diagnostics firm Seegene and Springer Nature have launched a new project for the development of diagnostic assays, as part of their ongoing strategic partnership.
September 3, 2024
CDC prioritizes mpox specimens for testing laboratories
By
LabPulse.com staff writers
The CDC recommended that all laboratories performing mpox testing send certain types of clinical specimens to a laboratory that can perform clade-specific testing as quickly as possible.
August 28, 2024
Seegene develops two RUO mpox assays
By
LabPulse.com staff writers
Seegene has developed two polymerase chain reaction (PCR) test assays for mpox research testing.
August 26, 2024
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