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The PCR-based assay is designed to detect RNA from the virus' nucleocapsid and ORF1ab genes in upper and lower respiratory specimens.
Emergency testing related to the SARS-CoV-2 pandemic strongly increased, but routine testing declined due to fewer regular health checks.
The test was already authorized for use in Canada and South Korea. Seegene has sold more than 10 million of the assay in more than 60 countries.
The test, which is used to screen for cervical cancer, was previously approved by the agency for use with the Cobas 4800 system.
The test is designed to detect SARS-CoV-2 E and RDRP genes in nasal, nasopharyngeal, and oropharyngeal swabs, as well as bronchoalveolar lavage specimens.
The Washington Post reports the Centers for Disease Control and Prevention test for SARS-CoV-2 failed due to contamination.
The test is a real-time RT-PCR assay for the qualitative detection of SARS-CoV-2 nucleic acid in nasal, nasopharyngeal, and oropharyngeal swab specimens.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.
The two tests are designed to detect SARS-CoV-2 nucleic acid and run on any authorized RT-PCR instrument, according to the FDA.
The editorial board of the Pittsburgh Post-Gazette says other lawmakers should take Florida's approach and provide additional protections against genetic discrimination.
The Hill reports 17 states and the District of Columbia are suing over a new policy that would strip international students of their visas if they only attend classes online.
Centers for Disease Control and Prevention employees call on the agency to label racism a public health crisis and examine its own policies, NPR reports.
In PNAS this week: genetic evidence for Inca resettlement, analysis of spermatogonial stem cell transcriptomes, and more.