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More articles about Regulatory News & FDA Approvals

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.

The company's Eonis assay, which leverages RT-PCR technology, can be used to simultaneously tests for SMA, SCID, and XLA in newborns.

The newly CE-IVD-marked devices are part of the company's DNA/RNA Shield line of sample collection, preservation, and transportation products.

The test runs on multiple GeneXpert systems and tests nasopharyngeal and nasal swabs or nasal wash/aspirate specimens.

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.

Both of the RT-PCR-based tests use healthcare provider-collected samples and may be used by any lab CLIA-certified to perform high-complexity tests.

The second EUA for a test that targets the ORF1a and N genes is for an automated version of a manual test that had been granted EUA in August.

The test is designed to detect two regions within the virus' nucleocapsid gene in upper respiratory specimens, according to the Puerto Rico-based company.

One of the revisions specifies that the ID Now test is for use with specimens collected within the first week of symptom onset.

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.

The firm's assay is also CE marked for use with nasal swabs, nasopharyngeal swabs, nasal wash and aspirates, and bronchoalveolar lavages.

The test is designed to detect and differentiate SARS-CoV-2, influenza A, and influenza B and runs on the company's benchtop Cobas Liat system.

The test can be used directly on any open instrument, including portable systems, and it allows for detection of pathogens in about 75 minutes.

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 company received Emergency Use Authorization from the US Food and Drug Administration last month for a SARS-CoV-2 total antibody test.

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.

Verily's test is a modified version of Thermo Fisher Scientific's authorized TaqPath COVID-19 Combo Kit that can be used with pooled samples.

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Nature News writes that additional details about the UK plan for an agency to support high-risk, high-reward science are needed.

The New York Times reports that the US Food and Drug Administration has authorized Johnson & Johnson's SARS-CoV-2 vaccine.

The Wall Street Journal writes new studies are giving glimpses into the origins of SARS-CoV-2.

In PLOS this week: analysis of Plasmodium population structure, qPCR assay to diagnose scabies, and more.