What level of experience does the lab doing HPV DNA have?

The protocol and validation of our HPV testing was developed at the Molecular Infectious Disease Laboratory (MIDL) of the Genetics & IVF Institute. MIDL was established in 1998, and is a cutting-edge CLIA-certified facility dedicated to infectious disease diagnostics using exclusively high-sensitivity PCR (DNA) amplification methods. All in-house protocols presently in use must pass a multi-part validation process. Prior to offering the HPV test in 2001 approximately 10,000 assays were performed.

In addition to supporting the activities of various GIVF divisions, of which Fairfax Cryobank is one, MIDL provides high-priority testing for prenatal and neonatal units for hospitals in the Washington, D.C. metro. MIDL is directed by Brian D. Mariani, Ph.D., who has 25 years of experience in molecular genetics, microbiology and biotechnology. Trained at Stanford and Harvard universities, Dr. Mariani has applied his expertise at MIDL to the design of molecular genetic-based detection assays for a variety of infectious microorganisms from diverse clinical specimen types.

Has the testing accuracy been validated by outside agencies?

The Molecular Infectious Disease Lab (MIDL) of Genetics & IVF Institute performs in-house validated assays under CLIA certification (#49D0952503) according to all established guidelines. The lab director is qualified for Molecular Virology under N.Y. State Dept of Health guidelines. The lab participates in the College of American Pathology nucleic-acid amplification survey program (including HPV detection) and maintains a 100% accuracy score.