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More articles about Regulatory News & FDA Approvals

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.

The kit uses components that are chemically identical to ones in the SARS-CoV-2 test kit that the company offers in the US under an Emergency Use Authorization.

The endpoint RT-PCR test is processed on the company's Encompass CARD cartridge, which runs on Rheonix's Encompass MDx workstation.

The FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.

The test is a modified version of Thermo Fisher Scientific's TaqPath COVID-19 SARS-CoV-2 Test, which received Emergency Use Authorization last month.

The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May.

The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.

The RT-PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in a range of upper and lower respiratory specimens including nasal swabs and sputum.

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The US has sent its formal notice of withdrawal from the World Health Organization, according to the Wall Street Journal.

The Harvard Crimson reports that Harvard and MIT are suing the Department of Homeland Security and ICE over the new international student visa policy.

Science reports that a draft spending bill would increase the US National Institutes of Health budget by 13 percent.

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.