[Histonet] New assays From R&D to clinical applications

From:Li Clarke

We would appreciate some guidance in bringing a "home-grown" assay into 
clinical use. 
1.  What are the guidelines regarding FDA approval?
2.  How to determine the appropriate CPT code for billing
3.  What are regional prices for these types of tests?


Li Clarke
Administrative Director, Pathology
Harborview Medical Center
Box 359791
Phone: 206.731.2166 / Fax: 206.731.4821
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