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University of Michigan Study Shows SEQUENOM's MassARRAY Technology Identifies HPV Infections Missed by Standard Hybridization Test
Date:7/13/2009

SAN DIEGO and ANN ARBOR, Mich., July 13 /PRNewswire-FirstCall/ -- Results from a study published by the University of Michigan have shown that as many as 15% of women in the study group determined to be negative for the presence of human papillomavirus (HPV) in the cervix, via the most commonly used test for HPV DNA, may actually be infected with the virus at clinically relevant viral loads. PCR-MS detected the presence of high-risk HPV in nearly half (46.7%) of women who tested negative by the Hybrid Capture 2 (HC2) test, which is standard of care in many countries. Approximately 9,000 American women are diagnosed with cervical cancer each year despite regular cervical screening. The study, titled, Development and Evaluation of a PCR and Mass Spectroscopy-based (PCR-MS) Method for Quantitative, Type-specific Detection of Human Papillomavirus, will be published in the September 2009 edition of Journal of Virological Methods. The assay used in this study is exclusively licensed by SEQUENOM (Nasdaq: SQNM).

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"We found that nearly half of the 75 women who had been called HPV-negative by the HC2 test had detectable levels of HPV DNA by the PCR-MS method," said Divya Patel, PhD, MPH, of the University of Michigan, one of the study investigators, and lead author of the recently published paper. "More importantly, because the PCR-MS method also measures the quantity of HPV relative to the number of human cells in the sample, or 'viral load,' we determined that about 15% of these samples had HPV loads comparable to the HPV loads found in women called HPV-positive by the HC2 test. While further work to define clinically meaning
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