Hologic Releases the Results of the Cervista(TM) HPV Clinical Trials
BEDFORD, Mass., Nov. 13 /PRNewswire-FirstCall/ — Hologic, Inc. , a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced the results of the Cervista HPV high-risk pivotal clinical trial. The Cervista HPV high-risk test is currently under review by the FDA in the U.S. and is expected to be launched in the European Union (EU) early in 2009. The clinical and analytical performance of Cervista HPV high-risk test results are scheduled to be presented at the European Research Organization on Genital Infection and Neoplasia (Eurogin) HPV conference in Nice, France on Saturday, November 15th 2008. Due to an early publication of the abstract by the conference organizers, Hologic has brought forward the release of this data.
The Cervista HPV high-risk test is designed to detect the 14 high-risk types of HPV that cause cancer. The proposed intended use of the test is as a general screen, in combination with cervical cytology (pap test), to help guide patient management for women 30 years of age or older, and as a triage for ASC-US cytology results to determine the need for referral to colposcopy. The trial enrolled over 4,000 women including more than 1,300 women with equivocal pap results called ASC-US, from 89 locations across the United States. Hologic is pleased to announce that the clinical trial met or exceeded all of the target end points. The results of the study were as follows:
— 100% CIN3 detection and a corresponding negative predictive value of 100%. Patients with CIN3 are at the highest risk of developing cervical cancer.
— The sensitivity of the test for CIN2+ was 92.8%, with a corresponding negative predictive value of 99.1%. Patients with CIN2 are at risk of developing cervical cancer, however this risk is not as high as it is for those diagnosed with CIN3.
— When compared to the ASC-US/LSIL Triage Study (ALTS), the Cervista HPV high-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-risk trial 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 indeterminate rate (i.e. inability of the test to give a result) of less than 1% and no cross reactivity with commonly reported low-risk HPV types.
— An internal control that minimizes the potential for a false negative result 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 not sufficient” samples that are burdensome to the lab, physicians and patients alike.
— Workflow advantages for the laboratory. The Cervista HPV high-risk test requires minimal hands on time, and yields a rapid time to results.
In addition to the results for the Cervista HPV high-risk test, Hologic also announced today the clinical trial results for the Cervista 16/18 test, a genotyping test for high-risk HPV types 16 and 18, which are responsible for approximately 70% of all cervical cancers. The Cervista(R) 16/18 test is also pending FDA approval. Similar to the high risk screening test, the Cervista 16/18 test results were compared to CIN2 and CIN3 clinical end-points. Two potentially important findings were Negative Predictive Values for 99.5% for CIN3 and 97.7% for CIN2+. Recent consensus guidelines released by the American Society 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 in women with ASC-US.” If regulatory approvals for the Cervista 16/18 test are obtained, 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 of the test should allow Hologic to compete in the rapidly growing HPV testing market both in the U.S. and internationally. The Cervista HPV high-risk test is currently under review by the FDA in the U.S. Hologic has obtained CE marking of the Cervista HPV test and is currently in the final stages of obtaining 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 premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic’s core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including reagents for a variety of DNA and RNA analysis applications. For more information, visit http://www.hologic.com/.
This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the effect and adoption of the use of the Cervista HPV testing products. There can be no assurance that the tests will achieve the detection rates demonstrated in the studies cited herein. Thus there can be no assurance of general adoption of this technology by the medical community. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in Hologic’s expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect Hologic’s business and prospects are described in Hologic’s filings with the Securities and Exchange Commission.
Contact: Deborah R. Gordon Frances Doria Vice President, Investor Relations Director, Investor Relations Hologic, Inc. Hologic, Inc. (781) 999-7716 (781) 999-7377
CONTACT: Deborah R. Gordon, Vice President, Investor Relations,+1-781-999-7716, or Frances Doria, Director, Investor Relations,+1-781-999-7377, both of Hologic, Inc.
Web site: http://www.hologic.com/