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The RT-PCR-based test is designed to detect three SARS-CoV-2 genes in saliva samples collected in the presence of a trained observer.
The firm attributed its quarterly and annual revenue gains primarily to sales of COVID-19 testing sample collection devices.
The liquid biopsy method analyzes fragment ends within recurrently protected regions in cell-free DNA from a patient's urine sample.
Azova's kit is for use with Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay, an extraction-free, saliva-based COVID test that previously received EUA.
The company also said that it had received EUA from the US Food and Drug Administration for a non-prescription version of its COVID-19 sample collection kit.
The company's cartridge for pneumonia for the Unyvero system is under review and pending approval by Chinese regulators.
Bio-Techne's CEO said the coverage decision will expand access to its EPI test and enable additional men to better decide whether to proceed with a prostate biopsy.
Hologic said that the transaction further strengthens its molecular diagnostics business by expanding its international capabilities, among other benefits.
The firm said it is currently also developing Novodiag Resp-4, a molecular test for the rapid, on-demand detection of the viruses.
The firm said it is drawing up plans for its business in a post-pandemic world, planning the introduction of new testing panels and enhancing its respiratory panel.
During a conference call, company executives also discussed results from the SMART NIPT trial and their outlook for Natera's three businesses.
The company recently announced a deal with personalized ctDNA testing firm Natera and will now follow that with the launch of its own MRD product this year.
The products combine next-generation sequencing and analysis with the company's NGSengine software to provide high-resolution HLA genotyping information.
The company doesn’t expect significant revenue from the test this year, but executives said that they are already seeing positive reception trends.
The company reported $112.4 million in revenues compared to $83.2 million in Q4 2019, beating the average Wall Street estimate of $106.6 million.
The cell analysis firm beat the consensus top line Wall Street estimates for Q4 and full-year 2020, but missed on the bottom line for the year.
GenMark said its ePlex molecular diagnostic product revenue for Q4 was $45.4 million, an increase of 138 percent over the fourth quarter of 2019.
The company is also continuing to expand its digital technology offering to help clinicians track their patients' health more easily.
Adaptive Cofounder and Chief Scientific Officer Harlan Robins compared the launch of the test to the unveiling of the Tesla Roadster electric sports car.
The company's nucleic acid extraction kits have offered labs relief from COVID-19-related shortages of traditional silica-based bind-wash-elute assays.
In a letter, about two dozen researchers criticize the World Health Organization investigation into the origins of SARS-CoV-2 and call for a new inquiry, the Wall Street Journal reports.
National Geographic reports that nine great apes at the San Diego Zoo have been vaccinated against SARS-CoV-2.
Janet Woodcock, the acting commissioner of the US Food and Drug Administration, speaks with NPR about SARS-CoV-2 testing and vaccines in the US.
In Science this week: genetic study of kidney fibrosis implicates the SOX9-NAV3-YAP1 axis.