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The University of Utah spinout said it will use the funding to enhance and expand its NGS-based Explify microbe identification platform and support its lab.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
The firm said it needs more time to ensure that the DetermaVu assay is providing the most consistent and sensitive results for patients.
The company is currently conducting clinical studies to validate AlloSure's technology — which underlies its kidney transplant test — in lung transplant patients.
The test showed 90 percent sensitivity and 75 percent specificity in a 250-patient blinded study, even without the addition of clinical risk information.
The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.
The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.
The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.
The company is developing a proprietary technology for the detection of RNA- and DNA-based genetic alterations in blood samples.
New analyses indicate female researchers are publishing less during the coronavirus pandemic than male researchers, according to Nature News.
A study suggests people with the ApoE e4 genotype may be more likely to have severe COVID-19 than those with other genotypes, the Guardian says.
Direct-to-consumer genetic testing companies are searching for a genetic reason for why some people, but not others, become gravely ill with COVID-19, the Detroit Free Press reports.
In PNAS this week: forward genetics-base analysis of retinal development, interactions of T cell receptors with neoantigens in colorectal cancer, and more.