PIPELINE
Diagnostic Test |
Marker Optimization |
Validation of Marker |
Clinical Validation |
Launch |
| caPCNA Key Stain™ |
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| caPCNA ELISA |
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| caPCNA Cytology |
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CS-Keys has established a pipeline of several novel cancer diagnostic tests based on caPCNA antibody technology.
The caPCNA Key Stain™ is an immunohistochemistry stain to be used as an aid to pathologists in examining tissue biopsies where cancer is suspected. The product will be available as an Analyte Specific Reagent, and sold to CLIA-certified labs, beginning in 2008.
The caPCNA ELISA uses a “sandwich” technique to detect the presence of caPCNA in the sample. This product will be used to monitor patient remission status. The company anticipates submitting a 510(K) to the FDA by the end of 2008.
caPCNA can also be applied to other diagnostic applications including cytology, immunoflorescence and advance imaging probes. (See Figure Below)
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