Hologic Releases the Results of the Cervista(TM) HPV Clinical Trials
BEDFORD, Mass., Nov. 13 /PRNewswire-FirstCall/ -- Hologic, Inc.(Nasdaq: HOLX), a leading developer, manufacturer and supplier of premiumdiagnostics, medical imaging systems and surgical products dedicated toserving the healthcare needs of women, today announced the results of theCervista HPV high-risk pivotal clinical trial. The Cervista HPV high-risk testis currently under review by the FDA in the U.S. and is expected to belaunched in the European Union (EU) early in 2009. The clinical and analyticalperformance of Cervista HPV high-risk test results are scheduled to bepresented at the European Research Organization on Genital Infection andNeoplasia (Eurogin) HPV conference in Nice, France on Saturday, November 15th2008. Due to an early publication of the abstract by the conferenceorganizers, Hologic has brought forward the release of this data.
-- 100% CIN3 detection and a corresponding negative predictive value of100%. Patients with CIN3 are at the highest risk of developing cervicalcancer.
-- The sensitivity of the test for CIN2+ was 92.8%, with a correspondingnegative predictive value of 99.1%. Patients with CIN2 are at risk ofdeveloping cervical cancer, however this risk is not as high as it is forthose diagnosed with CIN3.
-- When compared to the ASC-US/LSIL Triage Study (ALTS), the Cervista HPVhigh-risk test has a comparable specificity to the test used in that study.The ALTS trial is the best comparative trial for the Cervista HPV high-risktrial based on similarities in trial design.
The Cervista HPV high-risk test has additional advantages including:
-- The Cervista HPV high-risk test has demonstrated a low indeterminaterate (i.e. inability of the test to give a result) of less than 1% and nocross reactivity with commonly reported low-risk HPV types.
-- An internal control that minimizes the potential for a false negativeresult due to insufficient sample cellularity.
-- Small volume of liquid-based cytology sample required for HPV testing.Hologic believes that this will reduce the percentage of "quantity notsufficient" samples that are burdensome to the lab, physicians and patientsalike.
-- Workflow advantages for the laboratory. The Cervista HPV high-risk testrequires minimal hands on time, and yields a rapid time to results.
In addition to the results for the Cervista HPV high-risk test, Hologicalso announced today the clinical trial results for the Cervista 16/18 test, agenotyping test for high-risk HPV types 16 and 18, which are responsible forapproximately 70% of all cervical cancers. The Cervista(R) 16/18 test is alsopending FDA approval. Similar to the high risk screening test, the Cervista16/18 test results were compared to CIN2 and CIN3 clinical end-points. Twopotentially important findings were Negative Predictive Values for 99.5% forCIN3 and 97.7% for CIN2+. Recent consensus guidelines released by the AmericanSociety for Colposcopy and Cervical Pathology (ASCCP) in 2007 stated that"...it would be reasonable to utilize genotyping in cytology negative,HPV-positive women in the same manner as high-risk HPV testing is utilized inwomen with ASC-US." If regulatory approvals for the Cervista 16/18 test areobtained, Hologic will be well positioned to work with professional societies,physicians and laboratories to address the needs of this group of women.
The results of these clinical trials combined with the other attributes ofthe test should allow Hologic to compete in the rapidly growing HPV testingmarket both in the U.S. and internationally. The Cervista HPV high-risk testis currently under review by the FDA in the U.S. Hologic has obtained CEmarking of the Cervista HPV test and is currently in the final stages ofobtaining CE Mark approval for the sample preparation component of the test.The company expects to launch the product in the EU in January 2009.
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premiumdiagnostics products, medical imaging systems and surgical products dedicatedto serving the healthcare needs of women. Hologic's core business units arefocused on breast health, diagnostics, GYN surgical, and skeletal health.Hologic provides a comprehensive suite of technologies with products formammography and breast biopsy, radiation treatment for early-stage breastcancer, cervical cancer screening, treatment for menorrhagia, osteoporosisassessment, preterm birth risk assessment, mini C-arm for extremity imagingand molecular diagnostic products including reagents for a variety of DNA andRNA analysis applications. For more information, visit www.hologic.com.
Forward-Looking Disclaimer
This News Release may contain forward-looking information that involvesrisks and uncertainties, including statements about the effect and adoption ofthe use of the Cervista HPV testing products. There can be no assurance thatthe tests will achieve the detection rates demonstrated in the studies citedherein. Thus there can be no assurance of general adoption of this technologyby the medical community. Hologic expressly disclaims any obligation orundertaking to release publicly any updates or revisions to the data orstatements presented herein to reflect any change in Hologic's expectations orany change in events, conditions or circumstances on which any such data orstatements are based. Certain factors that could adversely affect Hologic'sbusiness and prospects are described in Hologic's filings with the Securitiesand Exchange Commission.
Contact: Deborah R. Gordon Frances Doria Vice President, Investor Relations Director, Investor Relations Hologic, Inc. Hologic, Inc. (781) 999-7716 (781) 999-7377SOURCE Hologic, Inc.
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