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The test does not require thermal cycling and uses a colorimetric readout, making it more amenable to high-throughput automation and rapid scale-up, the company said.
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The DeepChek-HIV assays are designed for settings running either Sanger sequencing or next-generation sequencing workflows, according to the company.
The FDA granted Emergency Use Authorization for Everlywell's at-home nasal swab collection kit, which can be used with Fulgent and Assurance's tests.
The PCR-based test works with upper and lower respiratory specimens, including nasal swabs and sputum, and can be performed by high complexity labs.
The company, which launched the technology in September 2019, said in its Q4 earnings release that it received high marks from beta testers.
The Cedars-Sinai Medical Center SARS-CoV-2 RT-PCR assay uses the A*Star Fortitude Kit 2.0 for the detection of SAR-CoV-2 specific RNA in nasopharyngeal swab samples.
The firm said it has begun distributing the Aptima SARS-CoV-2 test and expects to produce an average of 1 million per week.
With the US now awash in positive samples, assay developers seeking authorization will no longer be allowed to use contrived samples.
The company's Linea COVID-19 assay kit is a high-sensitivity real-time, reverse-transcriptase PCR-based assay to detect target sequences of the SARS-CoV-2 Spike gene.
The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.
The test is designed to detect the SARS-CoV-2 nucleocapsid gene in nasopharyngeal, oropharyngeal, nasal, and midturbinate nasal swab samples.
The test is designed to detect the E and RdRp genes of SARS-CoV-2 in various respiratory specimens including nasopharyngeal swabs and nasal aspirates.
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 US has sent its formal notice of withdrawal from the World Health Organization, according to the Wall Street Journal.
Science reports that a draft spending bill would increase the US National Institutes of Health budget by 13 percent.
The Harvard Crimson reports that Harvard and MIT are suing the Department of Homeland Security and ICE over the new international student visa policy.
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.