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The assay does not require nucleic acid extraction or purification, unlike a LumiraDx SARS-CoV-2 test that received Emergency Use Authorization in August.
DNA Genotek's devices are used with SARS-CoV-2 tests from Clinical Reference Laboratory and P23 Labs, while Clinical Enterprises' kit is offered by Eurofins.
A recent study showed that a method called affine transformation can be used to increase the number of true positive qPCR samples detected.
Novacyt said that the acquisition secures important intellectual property for its q16 and q32 rapid-PCR instruments for near-patient testing of COVID-19.
The company first submitted for 510(k) clearance last year and has received two additional information requests from the agency.
The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.
Yourgene will provide its Elucigene DPYD tests to screen approximately 200 patients each month for the next year.
Spectrum Solutions' specimen collection device is used with SARS-CoV-2 saliva tests from DxTerity Diagnostics and RUCDR Infinite Biologics.
With nearly 7 million COVID-19 cases, the country is expanding near-patient strategies historically deployed for tuberculosis testing for SARS-CoV-2 testing.
Under a licensing deal, Omixon will sell the AzureSeq-200 RT-PCR kit under its brand in Europe, the Middle East, and Africa.
The company's Advanta Dx SARS-CoV-2 RT-PCR assay received Emergency Use Authorization from the US Food and Drug Administration in August.
Seasun Biomaterials' test is designed to detect SARS-CoV-2 RNA, while Zeus Scientific's test detects IgG antibodies against the virus.
The agency provided the update on Wednesday in its weekly virtual town hall and on its FAQ page.
The test, called CovidNudge, is a version of DnaNudge's consumer DNA test that has been reengineered for the point-of-care detection of SARS-CoV-2.
The company has shipped more than 12 million ID Now tests across the US and more than 30 million total COVID-19 tests since March.
The firm said it expects its molecular diagnostics revenues to double year over year with orders continuing to outstrip its supply capabilities.
The awards will support clinical validation, manufacturing, and scale up for SARS-CoV-2 viral antigen and molecular detection.
The firm said that the FDA further amended an EUA for the Aptima SARS-CoV-2 assay to include the firm's pooling protocol for symptomatic testing.
BioFire's test is designed to detect and differentiate between SARS-CoV-2 and other respiratory pathogens, while UMass Medical's test is only for SARS-CoV-2.
The new method incorporates analysis of the amplification and melt curves and was used to create a single-channel nonaplex test using intercalating dye.
The Washington Post reports that US states and territories are seeking more funding for the distribution of SARS-CoV-2 vaccines.
The strain now accounts for about 80 percent of cases in Wales and Scotland, and about half of cases in England, the Guardian reports.
A new study suggests that using CRISPR to edit human embryonic DNA can lead to the loss of whole chromosomes, as the Associated Press reports.
In Science this week: ancient dog genomes highlight long ties with humans, genomic analysis of 40,000-year-old early East Asian individual, and more.