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All three tests use upper respiratory specimens such as nasal swabs, but the AIT and MicroGenDx tests can also use sputum samples.
Vela anticipates CE-IVD marking for an automated version of its test, and JN Medsys has received authorization for its test in Singapore and the Philippines.
The test is designed for the detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens as well as sputum.
The PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in various respiratory specimens including oropharyngeal and nasopharyngeal swabs.
The agency plans to work with a number of partners to develop codes that will describe tests and results to standardize data collection.
The Novodiag COVID-19 real-time PCR assay enables on-demand and fully automated detection of early COVID-19 infections in about one hour, the firm said.
The PCR-based assay is designed to detect RNA from the virus' nucleocapsid and ORF1ab genes in upper and lower respiratory specimens.
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 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 test is a probe-based reverse transcription PCR test for detecting the coronavirus by targeting conserved regions of its genome.
The PCR-based tests, which detect SARS-CoV-2 nucleic acid, are limited to use in the labs where they were developed, according to the FDA.
The test is designed to detect nucleic acid from SARS-CoV-2 in upper respiratory specimens such as oropharyngeal swabs and nasopharyngeal swabs.
The test is designed to detect one target sequence of the SARS-CoV-2 spike glycoprotein gene in nasopharyngeal and certain other respiratory specimens.
The company's RealAccurate Quadruplex Corona-plus PCR kit detects SARS-CoV-2 RNA from nasopharyngeal and oropharyngeal swabs.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The US has sent its formal notice of withdrawal from the World Health Organization, according to the Wall Street Journal.
Science reports that a draft spending bill would increase the US National Institutes of Health budget by 13 percent.
The Harvard Crimson reports that Harvard and MIT are suing the Department of Homeland Security and ICE over the new international student visa policy.
In Nucleic Acids Research this week: algorithm to determine molecular sequence types and other microbial features, computational method to uncover R-loop structures, and more.