History

IGeneX, Inc. is a specialty immunology laboratory and research facility, providing personalized service to over 1,000 private practice physicians, hospitals, and other clinical reference laboratories throughout the U.S. and Canada. The laboratory also functions as a pilot site for diagnostic manufacturers in the introduction of new assays, and has extensive collaborative agreements with multiple research groups.

The Reference Laboratory, founded in 1983, was purchased from 3M Diagnostic Systems (3MDS-Santa Clara, CA and BioWhittaker, Inc., Walkersville, MD) in 1991 by IGeneX, Inc. and moved to Palo Alto, California.

The laboratory is CLIA-certified, inspected by the Department of Health and Human Services for Medicare testing, and is also licensed in those states with special requirements (California, Florida, Maryland, New York, and Pennsylvania). The attached letter lists our certifications, validation protocols, and quality assurance practices.

Personnel include MDs, PhDs, and California licensed and nationally certified clinical laboratory scientists (medical technologists); research, accounting, and marketing staffs; and client service specialists. Directing the staff is Jyotsna S. Shah, PhD, CCLD, MBA; Clinical Consultant: Steven J. Harris, MD; and Nick S. Harris, PhD, AMBLI, President.

A letter from the President:

Our staff of professionals, who have worked together for many years, is committed to the following practices, ideals, and procedures:

  • State-of-the-art testing methodology;
  • Rapid turn-around-time;
  • Dedication to personalized testing;
  • Willingness and availability to answer your diagnostic questions;
  • Ongoing refinement of existing tests; and,
  • Research and development for innovative quality tests to enhance your diagnostic tools.

Nick S. Harris, Ph.D., ABMLI
President, IGeneX, Inc.

Laboratory Certifications
CLIA 05D0643914
Medicare ZZZ32759Z
CA State Dept of Health CLF4033
FL State Dept of Health 800002892
MD State Dept of Health 885
NY State Dept of Health 3172-805133A0
PA State Dept of Health 025659

Credits

The PCR is performed under a license from Roche Molecular Systems.

Procedures may change depending upon the availability of reagents from other manufacturers. IGeneX will notify customers when alternate methods are used.

Laboratory results should always be correlated to clinical findings.

IGeneX, Inc.
795 San Antonio Rd., Palo Alto, CA 94303 USA
Tel. 650.424.1191 / 800.832 3200 Fax. 650.424.1196