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The clinical chemistry and immunochemistry analyzer can now deliver up to 4,400 tests per hour, double its previous capacity.
A prescription-only version of the test was first authorized last year for the detection of three SARS-CoV-2 genes in a range of samples.
The global distribution deal with Epredia follows Paige's closing of a $125 million round of Series C financing earlier this year.
NEW YORK – What were the articles that gained the most interest from 360Dx readers last week? Here are the top five:
News items for the in vitro diagnostics industry for the week of March 15, 2021.
The US Securities and Exchange Commission alleges that uBiome's founders misled investors in order to close a Series C financing round in 2018.
The firm's Q4 core revenue rose 10 percent year over year to $501 million, driven by high volumes in its Clinical Laboratory and Transfusion Medicine product portfolios.
The firm's revenue decrease was largely driven by a decline in testing volumes due to the COVID-19 pandemic, it said.
The eight-month contract is for Abbott to provide 50 million BinaxNow SARS-CoV-2 antigen tests with the ordering period ending on Oct. 31.
The companies previously signed a letter of intent to work together on testing travelers in Canada, the US, Mexico, and the Caribbean for SARS-CoV-2 infection.
The test is the first COVID-19 assay to transition from Emergency Use Authorization to a cleared regulatory status.
The firms plan to build a workflow for CTC isolation directly from a patient's bloodstream for single-cell downstream molecular analysis such as sequencing, genotyping, or digital PCR.
Mologic will help develop and manufacture Aptamer's AptaDx SARS-CoV-2 test, which is designed to detect the spike protein antigen of the virus.
The deal covers SpeeDx's ResistancePlus and PlexPCR product lines, which include tests for sexually transmitted infections and antibiotic resistance.
The test returns results in less than 30 minutes and has shown 97 percent sensitivity and 96 percent specificity in both symptomatic and asymptomatic people.
XPhyto said it is in discussions with potential distribution and wholesale partners as well as potential licensees for the SARS-CoV-2 molecular test.
The new pathway allows developers of authorized tests that meet certain requirement to immediately obtain a screening claim.
The test was developed by Nal von Minden, which licensed its exclusive commercial rights in the US and Canada to Teracero.
The center also released updated guidance about how testing can be used as screening intervention, particularly in specific congregate settings.
The agency released two templates including a new one for developers of tests that detect or correlate to neutralizing antibodies against the coronavirus.
The company uses next-generation sequencing data to track the health of transplanted organs and stem cells over time.
The agency said it strongly recommends the use of POC nucleic-acid testing to diagnose HIV in infants and children younger than 18 months.
The analyzer can perform up to 870 tests per hour and can run Roche's full menu of clinical chemistry and immunochemistry assays.
The company's fourth quarter revenues rose to $12.7 million, while full year revenues rose to $42 million.
For the three months ended Dec. 31, the Boulder, Colorado-based firm reported revenues of $27.0 million compared to $8.3 million in 2019.