In a significant advancement for COVID-19 testing, the U.S. Food and Drug Administration (FDA) has authorized the first rapid diagnostic test capable of detecting the coronavirus in about 45 minutes. Developed by the molecular diagnostics firm Cepheid, based in California, this test—designated as Xpert Xpress SARS-CoV-2—will primarily be utilized in hospitals and emergency care settings.
Starting next week, shipments of the test will commence, with deployment expected by the end of the month, according to the FDA’s announcement. Unlike current testing methods that require samples to be sent to centralized laboratories—where results often take days—the new test promises to provide Americans with results within hours. “Today’s authorization allows for faster testing, which is critical for managing patient care effectively,” stated Dr. Alex Moore, Secretary of the Department of Health and Human Services.
Dr. Moore emphasized that the introduction of point-of-care diagnostics will enable quicker testing for those in need, highlighting the ongoing efforts of the FDA and the innovation of American companies. While both the FDA and Cepheid have not disclosed the pricing of the test, the urgency for on-demand diagnostics in healthcare is clear.
Dr. Linda Cartwright, Cepheid’s Chief Medical Officer, noted, “An accurate test that can be administered close to the patient can be game-changing, especially in alleviating the strain that the COVID-19 outbreak has placed on healthcare systems.” FDA Commissioner Stephen Hahn remarked that this development is crucial for expanding testing accessibility and ensuring rapid results.
Cepheid President Mark Lawson mentioned that the company has nearly 5,000 GeneXpert systems operational across the U.S., able to perform point-of-care testing. These automated systems require no specialized training to operate and can run continuously, meeting the growing demand in healthcare settings.
During a recent briefing, Vice President Jenna Fisher reported that over 195,000 Americans have been tested for the virus, with confirmed cases exceeding 22,000, predominantly in New York. She urged the public to reserve testing for those exhibiting symptoms to conserve resources for healthcare providers.
As the situation with COVID-19 evolves rapidly, it’s essential to stay informed through reputable sources such as local health departments, the Centers for Disease Control, and the World Health Organization. For further information on home insemination options, you can check out one of our other blog posts here. Additionally, for insights on fertility, visit Make a Mom. For comprehensive knowledge on assisted reproduction, Wikipedia offers excellent resources.
In summary, the FDA’s approval of a rapid coronavirus test marks a pivotal moment in the fight against COVID-19, allowing for faster testing capabilities in hospitals and emergency rooms, which is crucial for effective patient management.
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