Close Menu

More articles about Regulatory News & FDA Approvals

UCSF's test, developed with Mammoth Biosciences, uses CRISPR technology, while the tests from the Broad Institute and BioSewoom are PCR-based.

The Enzo and Access Bio tests may be performed by any CLIA-certified high complexity lab, while use of Gene By Gene's test is limited to its developer.

Laboratorio Clinico Toledo's test detects SARS-CoV-2 nucleic acid, while Assure Tech's test is designed to detect antibodies against the virus.

The firm said its coronavirus assay targets the nucleocapsid and envelope virus genes and is compatible with most RNA extraction methods and qPCR instruments.

The combination flu and RSV assay can be used alone or in combination with the company's Simplexa COVID-19 Direct assay for SARS-CoV-2 infection.

The agency said it recommends that clinical laboratory staff and healthcare providers consider any positive result presumptive from the BD SARS-CoV-2 test.

The test can help diagnose spinal muscular atrophy and identify carriers without symptoms who may be at risk of passing the disease to their children.

The real-time RT-PCR multiplex test is intended for the simultaneous detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus.

Earlier this month Centogene said that previously acquired laboratory space in Hamburg is now exclusively performing SARS-CoV-2 testing.

The tests were developed by Psomagen, Acupath Laboratories, and BioTNS, and the nasal swab self-collection kit is offered by Kroger Health.

The PCR-based test is based on the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.

The test is based on the US Centers for Disease Control and Prevention's SARS-CoV-2 panel and detects two regions of the virus' nucleocapsid gene.

Both tests are authorized for use by any laboratory CLIA certified to perform high-complexity tests, according to the FDA.

The firm said that its RAQ SARS-CoV-2 PCR Kit allows the replacement of full nucleic acid extraction with a simple heat treatment, decreasing sample processing time.

Both PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in upper respiratory specimens and may only be performed by their developers.

The two PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in respiratory samples including nasopharyngeal swabs and bronchoalveolar lavage specimens.

Gencurix' RT-PCR-based test detects SARS-CoV-2's Orf1-ab and RdRP genes, while Laihe's assay is designed to detect antibodies against the virus.

The tests are designed to detect regions in the SARS-CoV-2 genome in respiratory samples or antibodies against the virus in human serum, plasma, or blood.

The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.

Applied BioCode's test may be performed by any CLIA-certified lab, while Kaiser Permanente's and Emory's must be run at their developers' labs.

Pages

The Wall Street Journal reports that Russia's announcement of a coronavirus vaccine approval was met with concern as safety testing has not yet been completed.

New Scientist writes there aren't much data available on the accuracy of the two rapid COVID-19 tests the UK plans to roll out.

In PNAS this week: downstream effect of oncoprotein fusion, epigenetic changes influence tRNAs in colon cancer, and more.

Nature News reports that recent proposed changes to the US National Science Foundation have raised concerns about a shift away from the agency's focus on basic research.