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Invitae Publishes First Validation Data on MRD Assays, Laying Path to Future Clinical Expansion
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The analytical validity study is the first published featuring full performance data for the firm's Personalized Cancer Monitoring technology.
FDA's recommendation that Alzheimer's patients be tested for APOE status prior to starting the drug could lead to new regulatory approvals and payor coverage.
A year after the EU's In Vitro Diagnostic Medical Device Regulation took effect for new products, its implications for manufacturers and diagnostic labs are starting to emerge.
The creation of DNA nanoballs allows for the use of more simplified detection techniques, which potentially reduces the cost of testing.
In addition to proving clinical utility, the startup will have to navigate issues of regulatory strategy, sequencing technology, and additional indications.