Shots:
- C2N Diagnostics has entered into an agreement with BeauBrain Healthcare to offer PrecivityAD2 blood test for use in pts (≥50yrs.) with signs or symptoms of mild cognitive impairment or dementia in South Korea
- Study in The JAMA showed PrecivityAD2 improved diagnostic accuracy of Alzheimer’s disease vs SoC, while research in npj Dementia showed that the test demonstrated 91% accuracy, 90% sensitivity, & 92% specificity vs Amyloid PET imaging
- Additionally, the US FDA granted Breakthrough Device designation to C2N’s brain amyloidosis blood test, which also received medical device registration from the MHRA in the UK
Ref: Businesswire | Image: C2N & BeauBrain | Press Release
Related News: Cairn Surgical Reports the FDA De Novo 510(k) Submission for BCL System to Improve Accuracy of Lumpectomy
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