Tick Specialty Labs: Too Many Positive Findings?

They Save Lives

By James S., MD, MAR, PA, DABPN, DABFM

I asked Dr. Harris, from the internationally respected, IGeneX labs, to reply to the dubious comment that IGeneX "only has positive findings."

This is not valid for many reasons. First, many physicians using IGeneX get negative results. Further, IGenex has done quality assurance studies with appropriate negative findings in uninfected controls. And the company, as you can see below, has done a great deal to be certified and licensed.

The "all results are positive comment" is lazy, sloppy and uninformed. Lyme is the leading vector illness in the USA. A positive result should not be rare.

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IGeneX, Inc. is a reference laboratory located in Palo Alto, California specializing in Lyme disease and other tick-borne diseases. We take pride in the quality and diversity of the testing that we perform on samples from around the world.

IGeneX is licensed by CMS (Centers for Medicare and Medicaid Services) and is strictly regulated by CLIA. We are licensed in all states, including California, New York, Pennsylvania, Maryland, and Florida where special licensing is required.

The laboratory is inspected by these state and federal agencies on a regular basis. A Ph.D. consultant is also used to ensure that our laboratory is current with all the compliance regulations.

IGeneX participates in all proficiency programs required, such as New York State. Independent specialty laboratories, such as IGeneX, who have a narrow focus in testing, typically are not certified by CAP, but we do participate in the CAP Proficiency programs.

IGeneX has been testing clinical samples for over 11 years. The staff consists of a Laboratory Director, an MD Clinical Consultant, and several other MDs who also are licensed Clinical Laboratory Scientists who manufacture and perform tests. The personnel responsible for the test quality and performance are all licensed Clinical Laboratory Scientists, most of whom have been with IGeneX for many years. Our Research team is comprised of qualified PhDs and MDs and experienced Research Associates.

Customer Service is our main goal and the office staff is always willing to assist our patients and physicians. We take pride in our trained personnel that have worked together for years.

IGeneX is continually working on the advancement of existing tests. In addition, IGeneX is committed to designing and researching new technologies and opportunities. Our goal is to give Lyme patients and their physicians state-of-the-art tools for diagnosis of Lyme and other tick-related diseases.

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[Steve Andison Comment] The Federal Center for Disease Control periodically ships identified samples of what they know to be positive and negative samples to IGeneX to determine the accuracy of their testing procedures. Their accuracy rate for both positives and negatives is unsurpassed by any facility in the United States and with their state-of-the-art techniques and equipment, they may be the most accurate lab for diseases carried by ticks.

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