Under the agreement, NDT has an exclusive worldwide license for diagnostic use of a panel of nine antibodies to different tau protein forms.
Proceeds will go toward obtaining US Food and Drug Administration approval for its products, for research and development work, and for general corporate purposes.
The companies will initially offer C2N's PrecivityAD test in Argentina, Chile, Colombia, Dominican Republic, Ecuador, Jamaica, Mexico, Uruguay, and Venezuela.
The tissue-based next-generation sequencing assay analyzes 324 genes as well as genomic signatures including microsatellite instability and tumor mutational burden.
The test's new AI component is meant to help identify men who are at risk of having the severity of their tumor upgraded at ...
Notified bodies have been warning in recent weeks that the envisioned changes to the regulation might create new headaches for IVD makers in Europe.
NEW YORK – The US Food and Drug Administration granted 20 in vitro diagnostics-related 510(k) clearances in April for devices and assays, including antimicrobial susceptibility, infectious diseases, ...
While some still question the technology's benefit to labs' bottom lines, the industry has seen implementation of AI accelerate rapidly in recent months.
The guidelines now include Guardant's blood-based test Shield and Freenome's SimpleScreen, along with Geneoscopy's stool-based ColoSense assay and Abbott's Cologuard Plus assay.
The company, which received UKCA marking for the platform in February, also said it has secured a £2.1 million non-dilutive loan from Innovate UK.
NEW YORK – What were the articles that gained the most interest from 360Dx readers last week? Here are the top five: ...
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