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All the tests are authorized for use by CLIA-certified labs, while Visby's test may also be performed in a point-of-care setting.

Binx Health said the initial distribution of its platform will be to settings certified to perform moderate- or high-complexity diagnostic tests under CLIA.

BioIQ will offer Fulgent's next-generation sequencing-based coronavirus assay on its diagnostic testing platform.

The companies will work together to offer rapid SARS-CoV-2 antigen testing for travelers in the US, Mexico, Canada, and the Caribbean.

The Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit can detect and differentiate RNA from SARS-CoV-2, influenza A, and influenza B viruses.

The kit, developed by Gauss in collaboration with Cellex, uses a smartphone app to instruct an individual on how to collect a sample and perform the test.

In December, the firm was named a finalist in a $6 million Xprize competition to develop a rapid test for detecting SARS-CoV-2.

The PCR-based test, which is also now CE marked, provides a positive or negative result for each virus using a single specimen within three hours.

Fluidigm CEO Chris Linthwaite said the company aims to further penetrate the diagnostic and clinical markets with both its microfluidics and mass cytometry businesses.

Using a Cas13-based method, researchers at UCSB detected eight asymptomatic cases, while a single discrepant case had low estimated viral load.

Investors reacted favorably to a report Wednesday evening saying the Carlsbad, California-based firm is working with a financial advisor on a potential sale.

The test was previously cleared by the FDA for use with ethylenediaminetetraacetic acid plasma samples to manage BK virus in transplant patients.

The company said the study will evaluate the ability of its Reveal System to detect and characterize antimicrobial resistance of Gram-negative bacteremia samples.

The company said that the test, which detects IgG antibodies against SARS-CoV-2, can be used to measure immune responses to the virus and vaccines.

The firm also announced a COVID-19 testing deal with George Mason University and a CyTOF supply and distribution agreement with Zhejiang PuLuoTing Health Technology in China.

Qiagen reported total revenues of $571.2 million in Q4 compared to $413.5 million a year ago, beating analysts' expectation of $548.9 million.

The firm's CEO said that the deprioritization of its submission for a standalone SARS-CoV-2 assay running on its Verigene I molecular diagnostic instrument is puzzling.

The company said the money, which includes seed funding from Novalis Biotech, will be used in part to support the development of a saliva-based SARS-CoV-2 antigen test.

The firm's molecular diagnostics revenues rose 49 percent year over year to $57.8 million from $38.8 million in Q4 2019.

During laboratory validation, the test showed sensitivity against high viral loads of 97.1 percent and specificity of 99.9 percent, the UK government said.

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