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FDA Approves First Rapid COVID Test for Home Use

The Pharma Data

. “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.

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New HCV Test Enables Diagnosis and Treatment in a Single Visit

XTalks

Unlike traditional testing methods that require samples to be sent to central laboratories, this test utilizes a blood sample from the fingertip to detect HCV RNA, delivering results in approximately one hour. “This is the first HCV RNA detection technology sensitive enough for active case finding at the point of care.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs. Targeting the CNS directly has been successful in modern medicine.

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