Mar 2, 2021
Blood tests for biomarkers and the possibility of the first disease-modifying treatment on the horizon
Recent Alzheimer’s disease research has poised the field for a watershed period in diagnosis and treatment, which may begin as early as this year.
This shifting clinical landscape in Alzheimer’s research includes blood tests to identify possible biomarkers, the first FDA-approved tau PET ligand, and the possibility of the first disease-modifying therapy the amyloid beta (Aβ)-targeted monoclonal antibody aducanumab that may be approved by the FDA this year. Moreover, the treatment pipeline continues to see robust research activity, with both traditional and novel targets in development and clinical trials.
FDA Approves Quidel QuickVue At-Home COVID-19 Test webpronews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from webpronews.com Daily Mail and Mail on Sunday newspapers.
FDA Grants Emergency Use Authorization for Home Collection Kit for Advanta Dx SARS-CoV-2 RT-PCR Assay
March 01, 2021 08:30 ET | Source: Fluidigm Corporation Fluidigm Corporation
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AZOVA Digital Health Platform Provides Patient Questionnaire, Process for Prescription, Kit Purchase, Sample Collection, and Secure Delivery of Test Results
SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the AZOVA™ COVID-19 Test Collection Kit for use with the Fluidigm® Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the company’s Biomark™ HD platform.
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Covid-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.
Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can’t do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.
“It could be associated with a person in a high-risk congregate setting or it might not be, but without patient information, we don’t know what we don’t know,” Hamilton said. The group has asked federal officials to waive the rules. “Time is ticking.”