German Researchers Create Non-invasive Lab-on-a-Chip Biosensor That Detects Antibiotic Levels from Breath Samples

Should the device prove effective, it could replace invasive point-of-care blood draws for clinical laboratory testing during patient drug therapy monitoring What if it were possible to perform therapeutic drug monitoring (TDM) without invasive blood draws using breath alone? Patients fighting infections in hospitals certainly would benefit. Traditional TDM can be a painful process for patients, one that also brings risk of bloodline infections. Nevertheless, regular blood draws have been the...

Will Blowing in a Device Be Useful in Screening for COVID-19? FDA Grants Its First EUA for a Breathalyzer SARS-CoV-2 Screening Test

InspectIR COVID-19 Breathalyzer identifies a chemical signature associated with SARS-CoV-2 in about three minutes with 91.2% sensitivity and 99.3% specificity One company is hoping that it can make breathalyzers a viable, easier way to screen for SARS-CoV-2. It will soon have the opportunity to learn if consumers will accept this form of screening for COVID-19, as its device recently obtained an Emergency Use Authorization from the FDA. On April 14, 2022, InspectIR Systems, LLC, of Frisco,...

Columbia University Researchers Say New High-Speed 3D Microscope Could Replace Traditional Biopsy, with Implications for Surgical Pathology

Columbia University’s MediSCAPE enables surgeons to examine tissue structures in vivo and a large-scale clinical trial is planned for later this year Scientists at Columbia University in New York City have developed a high-speed 3D microscope for diagnosis of cancers and other diseases that they say could eventually replace traditional biopsy and histology “with real-time imaging within the living body.” The technology is designed to enable in situ tissue analysis. Known as MediSCAPE, the...

University of Washington Researchers Develop Home Blood Clotting Clinical Laboratory Test That Uses a Smartphone and a Single Drop of Blood

UW scientists believe their at-home test could help more people on anticoagulants monitor their clotting levels and avoid blood clots In a proof-of-concept study,researchers at the University of Washington (UW) are developing a new smartphone-based technology/application designed to enable people on anticoagulants such as warfarin to monitor their clotting levels from the comfort of their homes. Should this new test methodology prove successful, clinical laboratories may have yet one more...

Survey: Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation

Though response was limited in Dark Daily’s poll, the message from respondents was overwhelmingly negative on LDT regulation by the FDA Most respondents to a recent industry survey said that should Food and Drug Administration (FDA) approval be required in the future for laboratory developed tests (LDTs), innovation will suffer. This conclusion echoes what opponents of the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) have argued will happen should that proposed bill...
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