Immunovia Reports Positive Results of Next Generation Test from Model Development Study for Pancreatic Cancer Detection
Shots:
- The model development study of next generation test achieved both 1EPs and 2EPs showing 98% specificity and 75% sensitivity in early stage (I&II) detection of pancreatic ductal adenocarcinoma (PDAC)
- Study was designed to select highest-performing biomarker for next-generation test; included 133 blood samples from stage I&II PDAC patients and 384 control samples from high-risk hereditary & familial pancreatic cancer, diabetics, benign pancreatic lesions for PDAC, & healthy individuals from US & EU
- Completion of 2nd phase of study for additional statistical analyses is expected in 6-8wks; several analytical validations to confirm accuracy & reproducibility of protein biomarker measurements, and large clinical validation study to confirm test performance will be conducted in Q2-Q3’24 and Q4’24, respectively; US launch is expected in 2025
Ref: Immunovia | Image: Immunovia
Related News:- The US FDA Grants Orphan Drug Designation to Candel Therapeutics’ CAN-2409 as a Treatment for Pancreatic Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
