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COVID-19
NIH-backed project develops scoring system for identifying long-COVID patients
While multiple earlier studies have assessed the effects of long COVID, previous efforts largely had retrospective designs, relied on electronic health record entries, and lacked an uninfected comparison group.
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Sepsis
Validation data presented for Cytovale sepsis diagnostic test
COVID-19
Medical records link vaccination against COVID-19 to reduced risk of non-respiratory symptoms
Latest News
Malaria rapid tests in study show low performance for travelers to China
May 25, 2023
FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
May 25, 2023
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May 11, 2023
Illumina CEO remains on the board, chairman is voted out
May 26, 2023
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Business Insights
Regulatory Approval
FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
Financial Results
Agilent Technologies fiscal Q2 revenues rise 7%; firm trims full-year estimates
Policy and Regulation
Industry organizations urge Congress to protect access to laboratory tests
Immunoassays
Beckman Coulter analyzer developed 'from the ground up' to address IVD industry constraints
Diagnostic Technologies
Regulatory Approval
Eurobio Scientific obtains IVDR CE markings for PCR tests
Business Insights
Illumina CEO remains on the board, chairman is voted out
Financial Results
Agilent Technologies fiscal Q2 revenues rise 7%; firm trims full-year estimates
Molecular Diagnostics
Domus Diagnostics gets $2.4M NIH grant to develop at-home molecular test
Diseases
Malaria
Malaria rapid tests in study show low performance for travelers to China
Regulatory Approval
Eurobio Scientific obtains IVDR CE markings for PCR tests
Regulatory Approval
FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
Diabetic Nephropathy
Renalytix selects Eversana to expand commercialization of KidneyIntelX test for diabetic kidney disease
More from LabPulse.com
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
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
Antibody titer levels associated with protection against Omicron: Study
Immunoglobin G and neutralizing antibody titer levels were associated with protection against infection with the Omicron variant and against symptomatic disease.
May 23, 2023
Industry organizations urge Congress to protect access to laboratory tests
In a letter to Congress, provider organizations make the case that without congressional action, Medicare reimbursement cuts could jeopardize access to many clinical laboratory tests.
May 22, 2023
Beckman Coulter analyzer developed 'from the ground up' to address IVD industry constraints
At a time of scarce resources, the system requires no daily maintenance and only 10 minutes weekly and monthly maintenance, said Dr. Pamela Christudoss of Christian Medical College, who evaluated the analyzer prior to its broad launch last week.
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
Biomarkers may predict stem cell transplant risks
A biomarker for donor stem cell transplant risk may help doctors predict which patients will develop potentially deadly sinusoidal obstruction syndrome.
May 23, 2023
Cepheid announces former Philips executive Vitor Rocha as president
Rocha joins Cepheid after 12 years at Philips, where he was CEO of Philips North America and CEO of its global ultrasound business.
May 23, 2023
Lifespin debuts diagnostic service, an amino acid profiling panel
Analysis of the samples will be implemented by Lifespin at its sites in Germany and the U.S., and delivered to laboratory chain companies and healthcare providers as software-as-a-service.
May 22, 2023
