The FDA has cleared Aptitude’s next-generation Metrix COVID Test, which the company says offers 3-fold higher sensitivity and 30% faster results compared to its EUA version.
The COVID-19 pandemic has reshaped healthcare, diagnostics, and public health preparedness, leaving lasting impacts on the industry.
CovarsaDx supported OSANG Healthcare in securing FDA clearance for the QuickFinder COVID-19/Flu Antigen Self-Test and Pro Test.
The AMP published a consensus report on best practices for SARS-CoV-2 genomic surveillance using next-generation sequencing (NGS).
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Nasal autoantibodies can predict COVID severity, providing insights for personalized treatment and applications for other respiratory viruses.
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Researchers developed a new surveillance technique that can detect emerging COVID variants before they become widespread.
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Healgen Scientific’s Rapid Check COVID-19/Flu A&B Antigen Test received FDA De Novo authorization for OTC use.
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The new testing system uses Janus particles to rapidly detect viral proteins, with potential applications extending beyond COVID.
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Healgen Scientific launched the manufacturing facility to help produce the Healgen Rapid Check COVID-19/Flu A&B Antigen Test.
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The landscape of respiratory virus testing has evolved rapidly, driven by burgeoning diagnostic solutions like multiplex testing.
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A new study found routine lab tests may not effectively diagnose long COVID, underscoring the need for new biomarkers and diagnostic tools.
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Researchers have developed a bioelectric device using biomembranes to quickly detect and classify harmful variants of coronavirus.
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Watmind USA received FDA Emergency Use Authorization for its rapid OCT SpeedySwab Covid + FLU A&B Self-Test.
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A new study found that at-home antibody tests can effectively detect inadequate COVID immunity, aiding decisions about booster vaccinations.
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The FDA warned against using Cue Health’s COVID tests due to modifications that reduced test reliability and increased risk of false results.
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iHealth Labs received FDA Emergency Use Authorization for its COVID-19/Flu A&B Rapid Test Kit, enabling quick self-testing at home.
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The lab-developed test will help diagnose Long COVID and is aimed to provide accurate insights into personalized treatment approaches.
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The COVID test is cleared for those aged 14 or older when self-testing, and those aged two and older when administered by an adult.
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