The agency has suggested approaches like third-party review would help manage the expected influx of submissions, but labs and vendors remain concerned.
Germany to Test Genomics-Based Precision Medicine for Cancer, Rare Disease in National Pilot Project
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With reimbursement from public health insurance, the "model project" will run for at least five years and examine the utility of genomic sequencing for advanced cancer and rare disease patients.
The new system is targeting the clinical space and aims to assist in translating assays from research-use to in vitro diagnostics.
The automated instrument has been available for research use, but its target market will be expanded to include clinical diagnostic applications in the coming months.
The firm said it has secured US Food and Drug Administration breakthrough device designation for its test to classify infections and stratify patients by severe disease risk.
The laboratory services spinoff of Nonacus is launching sales of a next-generation sequencing-based test that could help determine which patients need cystoscopies.
Proteomics International Expects Licensing Deal, Medicare Coverage to Drive PromarkerD Sales in 2024
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The company is making its first major commercial push for its diabetic kidney disease test via a US licensing deal it inked this spring with Sonic Healthcare.