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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.
While the tests from Clinomics, UPenn, and Inno Diagnostics detect the SARS-CoV-2 virus, Princeton BioMeditech's test differentiates between SARS-CoV-2 and influenza.
In an SEC filing, the firm said it intends to use the IPO proceeds to support manufacturing and establish a sales and marketing team, among other activities.
Roche has invested CHF 600 million ($664 million) in manufacturing to add 90 manufacturing lines and has plans to launch 17 new tests in 2021.
The FDA and CDC call for a pause in administering Johnson & Johnson's SARS-CoV-2 vaccine while reports of rare blood clots are looked into, reports the Wall Street Journal.
According to the Associated Press, a Swiss program aims to shepherd long-term science projects and diplomacy.
CNN reports that two new studies suggest the B.1.1.7 SARS-CoV-2 variant may be more transmissible, but may not lead to more severe disease.
In PNAS this week: analysis of pathway affecting acute kidney injury, parental-specific allelic expression in horse placenta, and more.