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Point-of-Care Testing: Page 3
Cue Health granted first traditional FDA authorization for at-home test to detect respiratory illness
By
Leo O'Connor
The Cue COVID-19 Molecular Test detects genetic material from SARS-CoV-2 virus in nasal swabs from adults with signs and symptoms of upper respiratory infection.
June 6, 2023
Domus Diagnostics gets $2.4M NIH grant to develop at-home molecular test
By
Leo O'Connor
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
Cepheid announces former Philips executive Vitor Rocha as president
By
LabPulse.com staff writers
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
Zymo Research, Burst Diagnostics partner to develop, commercialize hand-held diagnostic testing platform
By
LabPulse.com staff writers
The device leverages a microfluidic cartridge that miniaturizes and integrates steps typically performed in the clinical laboratory setting, including washing and signal amplification, Zymo Research said.
May 18, 2023
LumiraDx Q1 revenues drop 82% as its transition from non-COVID tests takes shape
By
LabPulse.com staff writers
In April, the company had announced a cost restructuring program involving a reduction of its global workforce by approximately 40%. It now expects to see the full impact of the restructuring activities during the third quarter.
May 16, 2023
Peptide-based diagnostic testing shows promise in the monitoring of inflammatory diseases
By
Nick Paul Taylor
Switching from antibodies to peptides may address testing challenges. Peptides, sequences of up to 50 amino acids, bind to proteins with high affinity and selectivity, making them suitable for use in lateral flow tests.
May 17, 2023
Labcorp acquires Providence Oregon laboratory assets
By
LabPulse.com staff writers
Under an agreement, providers and patients will have access to Providence Oregon facilities and services as well as Labcorp testing capabilities and expertise.
May 16, 2023
CRISPR-based technology shows promise for oral health assessment
By
Kate Madden Yee
CRISPR-based technology could be used to assess a range of oral and systemic diseases, say researchers from the Forsyth Institute.
May 16, 2023
BioMĂ©rieux receives FDA CLIA waiver for multiplex PCR respiratory panel
By
LabPulse.com staff writers
In about 15 minutes, the panel detects five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV), and rhinovirus.
May 11, 2023
Cue Health submits de novo request to FDA for at-home molecular RSV test
By
LabPulse.com staff writers
Separately, Cue Health said it now offers over-the-counter and prescription medications for sexual health, birth control, hair loss, and more.
May 9, 2023
Stop using certain SD Biosensor Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics, FDA says
By
LabPulse.com staff writers
The FDA said in a warning notice published at its website on Thursday that it has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution provided in the test kit.
May 5, 2023
Labcorp to partner with Jefferson Health on lab services
By
LabPulse.com staff writers
Under the agreement, Labcorp will acquire some assets of Jefferson’s outreach laboratory services, while Jefferson will continue to own and operate its hospital labs for inpatient and outpatient services.
May 3, 2023
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