LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.
Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Archerdx, Bio-Rad, Cochlear, Invivoscribe, Ortho, Quidel, Theradiag, Thermedical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 1drop, Agilent, Edwards, Everlywell, Fulgent Genetics, Zebra Medical Vision.
Abbott Laboratories’ ID Now test for the SARS-CoV-2 virus made waves when it was introduced thanks to the rapid turnaround time the molecular test promised. But questions about the test’s performance have surfaced several times in recent weeks. The latest criticism comes from a study conducted at the New York University Langone Medical Center, which claims the diagnostic compared poorly against a competitor. However, the U.S. FDA said that it has questions about the swabs and transport media used in connection with the test. As a result, it will stand pat regarding the ID Now’s place in the emergency use authorization (EUA) program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Balt, Caredx, Hologic.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA, Medalliance.
The FDA’s weekly town hall on testing for the COVID-19 pandemic included the usual range of concerns about test performance, but concerns regarding swabs and sample sites continue to mount. The predicament has led to the announcement that the FDA along with the National Institutes of Health (NIH) will hold a May 15 town hall regarding swabs, with a particular interest in swabs produced via additive manufacturing.
