April 24, 2003
Two AmeriPath Studies Underscore Clinical Value of Prototype PCR Tests for HPV

Clearwater Beach, FL, April 24, 2003 – Researchers at the 19th Annual Clinical Virology Symposium in Clearwater Beach, Florida, today released results of two separate studies that underscore potentially significant clinical value of prototype polymerase chain reaction (PCR)-based diagnostic tests in determining genotypes of human papillomavirus (HPV). The studies, conducted by AmeriPath’s Center for Advanced Diagnostics of Orlando, Florida, involved a prototype Line-Blot Assay (LBA) , and prototype Micro-Well Plate (MWP) assay developed by Roche Molecular Diagnostics of Pleasanton, California, used in conjunction with Sure-Path® and Thin-Prep® liquid cytology medias (LCMs). HPV is the most common sexually transmitted viral infection of the lower genital tract, and is the leading cause of cervical cancer, affecting more than 500,000 women worldwide every year. DNA testing is gaining wider acceptance by the global medical community as both an adjunct test to the conventional PAP smear, and as a primary screening tool for the identification of women at risk for developing cervical cancer. There are more than 100 recognized subtypes of HPV, approximately one-third of which are spread through sexual contact. The medical community recognizes 13 of these as “high-risk” or oncogenic subtypes. DNA testing, including the Digene Hybrid Capture II® test, is now utilized to identify high risk (HR) and low risk (LR) subtypes.

The two studies presented at the Clinical Virology Symposium involved an evaluation of the Roche Prototype LBA for detection and genotyping from Sure-Path liquid cytology specimens, and evaluation of the Roche prototype MWP and LBA for resolution of HCII high-risk panel indeterminate Thin-Prep® liquid cytology specimens, respectively.

In the first study, a total of 140 cervical cell samples collected in Sure-Path medias were obtained following PAP slide preparation, and HPV detection was performed with HCII. Prior to HPV detection using the prototype LBA, genomic DNA was extracted from residual cell pellets suspended in Sure-Path media (38/140), and from residual cell pellets suspended in Digene specimen transport medium (102/140) using a QIAamp Min Elute viral nucleic acid extraction kit. LBA HPV detection followed hybridization of PCR-amplified DNA sequences to HPV genotype-specific probes on the LBA.

Testing showed that of the 60 specimens, which tested negative for HR-HPV by HCII, the prototype LBA detected one or more LR-HPV genotypes in 20 percent, and one or more HR-HPV genotypes in 13 percent of these specimens. Of the remaining 80 specimens that tested HR-HPV positive, 80 percent exhibited one or more HR-HPV genotypes, including 18 specimens that exhibited types not detected by HCII. An additional 20 percent were actually found to be either HPV negative or LR-HPV positive only.

The second study, which focused on clarifying “indeterminate” results from HCII tests performed using samples collected in Thin-Prep® media (reported as approximately 4-5 percent of cases tested in the AmeriPath laboratory), showed that 90 percent of these cases could be resolved using the prototype LBA and MWP assays, and 84 percent were resolved with complete concordance between the LBA and MWP assays. This, according to principal investigator Dr. Jane Gibson of AmeriPath, is very significant, considering the importance of accurately delineating HR and LR HPV-positive results, in terms of patient management and care strategies.

“These studies both underscore the significant potential of prototype PCR tests for HPV, in terms of improving the overall accuracy and ability to differentiate high and low risk subtypes,” said Gibson. “In the first study, we see the prototype LBA is reliable for HPV genotype detection from cytology specimens collected in Sure-Path liquid cytology media. Results from the second study support the use of both the prototype LBA and prototype MWP assays to resolve indeterminate HCII results. This added level of accuracy and clarification can be extremely important in managing HPV in the future, for both patients and physicians.”

AmeriPath is a leading national provider of cancer diagnostics, genomics, and related information services. The Company’s extensive diagnostics infrastructure includes the Center for Advanced Diagnostics (CAD), a division of AmeriPath. CAD provides specialized diagnostic testing and information services including Fluorescence In-Situ Hybridization (FISH), Flow Cytometry, DNA Analysis, Polymerase Chain Reaction (PCR, performed pursuant to an agreement with Roche Molecular Systems, Inc.), Molecular Genetics, Cytogenetics and HPV Typing. Additionally, AmeriPath provides clinical trial and research development support to firms involved in developing new cancer and genomic diagnostics and therapeutics.

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