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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.
The firm's stock price has dropped since the announcement that the agency would need additional information and it has paused test shipments.
Using the BRAF-V600 tumor mutation as a marker, investigators identified pre-treatment and on-treatment ties between ctDNA and patient outcomes.
Binx Health said the initial distribution of its platform will be to settings certified to perform moderate- or high-complexity diagnostic tests under CLIA.
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.
Executives mapped out the next few years for the firm, estimating a deceleration in COVID-19 testing beginning the second half of 2021.
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 collaborators are requesting submissions including budget proposals to scale all supporting components of diagnostic test manufacturing.
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.
The firm's quarterly revenues beat estimates. Its full year revenues also beat estimates and were up 10 percent year over year.
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 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 Spanish firm also expects to release clinical data on its early-stage, next-generation sequencing-based colorectal cancer test in the first half of 2021.
The firm's molecular diagnostics revenues rose 49 percent year over year to $57.8 million from $38.8 million in Q4 2019.
Under the agreement, Beckman Coulter will sell and distribute Genedrive's high-throughput SARS-CoV-2 test in the US and Europe.
The assay kit also received interim authorization from Health Canada on Jan. 21 and will be used by a large Canadian provincial authority.
New analyses indicate the P.1 variant found in Brazil may be able to infect people who have already had COVID-19, the New York Times reports.
According to CNBC, Novavax's CEO says its vaccine could be authorized in the US as early as May.
The US National Institutes of Health has a new initiative to address structural racism in biomedical research.
In PNAS this week: GWAS of TLV-1-associated myelopathy/tropical spastic paraparesis, analysis of twins with hypertrophic cardiomyopathy, and more.