Diagnostics Solutions Strategic Priorities
Recent Breakthrough Device Designations (BDDs)
Leading innovation recognized by the FDA
FDA BDD
Infectious diseases
Oncology
Women's health
CNS
Others
cobasⓇ EBV: EBV in
transplant patients
cobasⓇ BKV: BKV in
transplant patients
FACT CDx (liquid biopsy
assay): 70 oncogenes +
MSI + bTMB
ElecsysⓇ GALAD score:
Diagnosis of early stage
hepatocellular carcinoma
ElecsysⓇ GDF-15: GDF-15
ElecsysⓇ sFlt-1/PIGF: rule-
out of Preeclampsia within 1
week
ElecsysⓇ B-Amyloid and
ElecsysⓇ p-Tau in Cerebro
Spinal Fluid assays: PET
concordance and
progression in Alzheimer's
Disease
in cachectic patients with
solid tumors¹
CoaguCheck® Direct-X:
Patients on Factor Xa
EBV: Epstein-Barr virus; BKV: BK virus; FDA: Food & Drug Administration; CDx: Companion Diagnostics; CNS: Central nervous system; 1 Treated with Pfizer Inc.'s investigational drug PF-06946860
Roche
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