Close Menu

More articles about Regulatory News & FDA Approvals

The expansion increases the number of PCR instruments and types of reagents and consumables labs can use to run the Applied Biosystems TaqPath COVID-19 Combo Kit.

The cancer test developer will use the funding to commercialize its enrichment-based NGS panels. An IVD test also got CE marked.

The PCR-based test received EUA for use on the Alinity m platform after receiving authorization in March on the firm's m2000 RealTime System. 

The PCR-based tests are designed to detect the SARS-CoV-2 nucleocapsid gene in various respiratory specimens including oropharyngeal swabs.

The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.

The federal agency approved the use of the Zymo Research SARS-CoV-2 kit with both upper respiratory and lower respiratory specimens.

The multiplex RT-PCR test simultaneously detects two target sequences inside the SARS-CoV-2 N gene, providing results in about two hours.

The system is approved for use with the Procleix Ultrio Elite Assay, the Procleix WNV Assay, Procleix Zika Virus Assay, and the Procelix Babesia Assay.

The kit is designed to detect viral RNA extracted from various respiratory samples including sputum, providing results within three and a half hours.

The company said its test, which provides results in approximately one hour, is the first instance of CRISPR technology being authorized by the FDA.

The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.

The company had received CE marking for the test in April, allowing for its use as a clinical diagnostic test in Europe.

Both RT-PCR tests are designed to detect SARS-CoV-2 nucleic acid in nasal swabs, although Sansure's test can be used with other respiratory specimens.

The triplex assay can be used on the firm's QX200 or QXDx Droplet Digital PCR systems to process 93 patient samples per run.

The panel is designed to detect and differentiate between nucleic acids from SARS-CoV-2 and 20 other viral and bacterial respiratory pathogens.

Wadsworth's test detects antibodies against SARS-CoV-2 in serum, while Altru Diagnostics' test detects viral nucleic acid in respiratory specimens.

The rapid automated RT-PCR test detects SARS-CoV-2 from nasopharyngeal, oropharyngeal, or nasal swab specimens and runs on NeuMoDx's Molecular Systems.

The RT-PCR-based test kit is designed to detect the RdRp and E genes of the virus in various respiratory specimens including nasopharyngeal swabs and sputum.

The German company's real-time PCR test is designed to detect SARS-CoV-2 genes E and RdRP in respiratory samples.

The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.

Pages

President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.

A study of Great Danes homes in on a genomic region linked to fearfulness.

CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.

In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.