Navigation Links
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 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 " 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

Forward-Looking Disclaimer

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

SOURCE Hologic, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. ALS Therapy Development Institute Partners with Clinical Centers to Establish Pathological Mechanisms of Lou Gehrigs Disease
2. Three Year Analysis of Treatment Efficacy, Cosmesis, and Toxicity Support use of the Hologic Mammosite Radiation Therapy System
3. Eularis Releases First-Ever Study on ROI of Pre-Launch Named Patient Programmes
4. Genaera Releases Phase 1 Data and New Preclinical Data on the CNS Function of Trodusquemine (MSI-1436) at CBI Obesity Summit
5. QRxPharma Releases Additional Phase 3 Data for Q8003IR Dual Opioid Pain Therapy
6. CenterWatch Releases State of the Clinical Trials Industry 2008 - A Key Industry Resource for Market Research and Competitive Intelligence
7. QRxPharma Releases Successful Phase 3 Study Results for Dual Opioid Pain Therapy
8. Immunosyn Releases Wound Healing Photographs From the First Phase Proof of Concept Trial in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019
9. TCS Healthcare Technologies Releases Three New Clinical Care Programs Within ACUITY
10. Immunosyn Corporation Releases SF-1019 Study Results
11. Cardinal Health Releases New Tool to Combat MRSA Infections in Hospitals
Post Your Comments:
(Date:11/30/2015)... , Nov. 30, 2015   Nuance Communications, Inc. ... National Decision Support Company (NDSC) today jointly announced ... collaboration capabilities that utilize the American College of Radiology,s ... provider organizations to comply with current and emerging ... --> By combining clinical decision support, ...
(Date:11/30/2015)... , Nov. 30, 2015 Varian Medical Systems (NYSE: ... develop an educational partnership with Apollo Hospitals Group, the largest hospital ... that will help train radiation technologists in the country. The MoU ... of Apollo Knowledge, and Ashok Kakkar , Varian,s ... India , Varian intends to deploy ...
(Date:11/30/2015)... , Nov. 30, 2015   VolitionRx Limited (NYSE ... diagnostic tests for a broad range of cancer types and ... LD Micro Conference, which will be held December 1 - 3 ... from VolitionRx will be David Kratochvil , Chief Financial ... of Investor Relations. ® blood-based tests for ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... California-based ... 15 years, announced today that Michigan-based Family Health Center (FHC) has selected i2iTracks ... 45 years, FHC was awarded the largest Affordable Care Act grant for Federally ...
(Date:11/30/2015)... ... November 30, 2015 , ... In an interview with Andy Mitchell of Peconic ... on Long Island’s east end. During the broadcast, entitled “Eyes: the Window to the ... glaucoma and cataracts, and how a visit with his grandmother to her physician put ...
(Date:11/30/2015)... ... November 30, 2015 , ... Holcomb ... the leading plastic surgery practices in Florida, is proud to announce that Dr. ... surgical innovations giant Ethicon Inc., a Johnson & Johnson Company. , Ethicon is ...
(Date:11/30/2015)... ... November 30, 2015 , ... Vasont ... their Vasont Universal Integrator (VUI) extension unites with Syncro Soft’s latest software update, ... as a continuous process with the latest release of oXygen® XML editor and ...
(Date:11/30/2015)... ... November 30, 2015 , ... SIMmersion’s ability ... to the medical schools of the future. To reach an audience of key ... 2015 ChangeMedEd conference in Chicago, organized by the American Medical Association. , ...
Breaking Medicine News(10 mins):