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 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 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 test is designed to detect one target sequence of the SARS-CoV-2 spike glycoprotein gene in nasopharyngeal and certain other respiratory specimens.
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.
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.
