Exhibit 99.2
DEPARTMENT OF HEALTH & HUMAN SERVICES | Public Health Service |
Food and Drug Administration | |
2098 Gaither Road | |
Rockville MD 20850 | |
October 13, 2006 |
Via Federal Express
Matt Watson, CEO
Combimatrix Molecular Diagnostics
310 Goddard, Suite 150
Irvine, CA 92618
Dear Mr. Watson:
We would like to thank you for meeting with us on September 14, 2006, to discuss your microarray based Constitutional Genetic Array Test (CGAT). We believe that scientific advances in this area have the potential to significantly impact the field of molecular diagnostic testing, and we are very interested in following developments in technologies for chromosomal copy number determination.
In your letter dated September 18, 2006, you have expressed the opinion that the CGAT is not an In Vitro Diagnostic Multivariate Index Assay (IVDMIA). We agree with your assessment. We do not believe that your device, as described, meets the definition of an IVDMIA as defined in the Draft Guidance document on IVDMIAs.
No further information is needed at this time. If you have additional questions, please feel free to contact me at 240-276-0450.
Sincerely yours, | ||
/s/ Steven I. Gutman | ||
Steven I. Gutman, M.D., M.B.A. | ||
Director | ||
Office of In Vitro Diagnostic Device | ||
Evaluation and Safety | ||
Center for Devices and Radiological Health |