The tests are designed to detect viral nucleic acid in various respiratory specimens including nasal swabs, nasal aspirate, and bronchoalveolar lavage.
The RT-PCR-based test, which runs on Becton Dickinson's BD Max system, simultaneously detects SARS-CoV-2, influenza A and B, and respiratory syncytial virus.
Both RT-PCR tests are for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B from throat swab samples.
The nanopore sequencing-based test is designed to both diagnose SARS-CoV-2 infection, as well as monitor mutations that may affect efforts to combat the virus.
The test is designed to detect two regions within the virus' nucleocapsid gene in upper respiratory specimens, according to the Puerto Rico-based company.
Visby's test is a fully integrated PCR device that detects SARS-CoV-2 RNA, while SNIBE's test comprises assays for two different antibodies against the virus.
Overall, GenMark's ePlex Respiratory Pathogen Panel 2 provides results for more than 20 viruses and bacteria, including SARS-CoV-2, flu A and B, RSV, and rhinovirus.
The company said that dried blood-spot sampling improves access to HIV diagnostic testing and care, particularly among HIV-infected people living in remote areas.
The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
