Statement by Vincent Lombardi

STATEMENT OF VINCENT LOMBARDI, PhD
CLINICAL LAB DIRECTOR
VIP Dx

A number of recent publications and individuals have mischaracterized the nature of certain clinical laboratory results reported by VIP Dx, a CLIA certified clinical laboratory. VIP Dx has met the required CLIA Program standards and is certified to offer and perform only clinically validated laboratory tests. The “XMRV test” offered by VIP Dx is clinically validated and performed under rigorous protocols to ensure the accuracy and reliability of the test results. XMRV testing was offered based upon the existing scientific knowledge at the time. The original assays for XMRV testing were based on the 2009 Science publication. Those assays, as well as all subsequent modifications, were internally validated prior to being used to process patients’ samples. WPI’s Research Director was instrumental in the decision to make such a test available to physicians. The interpretation of the XMRV test results, as with all laboratory tests, is the responsibility of the ordering physician.

Before offering any test to the public, VIP Dx established comprehensive performance specifications including accuracy, precision, analytical sensitivity, specificity, and others required for test performance.