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

Li Clarke liclarke <@t> u.washington.edu
Fri Jan 12 17:44:56 CST 2007

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
liclarke <@t> u.washington.edu	
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