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C2N Diagnostics & LSI Medience have partnered to pursue regulatory approval & commercialization of the PrecivityAD2 blood test for Alzheimer’s disease in Japan, following its recent US FDA clearance
Under the Japan domestic sales agreement, LSI Medience will act as distributor, seek Japanese IVD approval & support insurance coverage, while PHC Group company Mediford continues research testing services in Japan since 2024
PrecivityAD2 is a mass spectrometry-based multi-analyte blood test for adults aged ≥40yrs with cognitive impairment; in a 1,142-subject validation study, Positive & Negative results showed 97.6% PPV & 93.1% NPV for amyloid pathology
Ref: Business Wire | Image: C2N Diagnostics & LSI Medience | Press Release
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The post C2N Diagnostics and LSI Medience Partner to Commercialize PrecivityAD2 Blood Test for Alzheimer’s Disease in Japan appeared first on PharmaShots.
C2N Diagnostics and LSI Medience Partner to Commercialize PrecivityAD2 Blood Test for Alzheimer’s Disease in Japan | PharmaVoice