Navigation Links
FDA APPROVES APTIMA HPV ASSAY FOR USE ON HOLOGIC'S PANTHER SYSTEM
Date:7/23/2013

BEDFORD, Mass., July 23, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has approved Hologic's Aptima HPV assay for use on the Company's fully-automated Panther system. The Aptima HPV test is performed with Hologic's ThinPrep liquid cytology specimen and can be tested before and after it has been processed for cytology testing on the ThinPrep 2000 system.

Hologic's Aptima HPV mRNA based assay is a nucleic acid amplified test that detects 14 high-risk strains of human papillomavirus (HPV) associated with cervical cancer and precancerous lesions, and has demonstrated significantly improved specificity with no compromise in disease detection. The addition of the Aptima HPV assay to the Panther menu extends the capability of low to high-volume laboratories to run multiple tests from a single specimen, on a cost effective, highly flexible and fully-automated molecular testing platform.

Created to be a "sample-in-result-out" instrument, the Panther system eliminates batch processing and automates all aspects of nucleic acid testing on a single, integrated platform.

"Our Panther system is a world-class automation solution for a broad range of molecular diagnostic laboratories," said Rohan Hastie, Senior Vice President and General Manager, Diagnostics. "Expanding the menu of available assays on Panther builds on our platform-centric strategy of delivering workflow efficiencies and revenue generating opportunities to our laboratory partners."

About the Hologic Aptima HPV Assay

The Aptima HPV assay detects messenger RNA overexpressed from the E6 and E7 viral oncogenes in 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Cervical cancer is one of the most common cancers among women in the world, and HPV is responsible for more than 99% of all cervical cancers.1-3

The Aptima HPV test is performed with Hologic's ThinPrep liquid cytology specimens, which are routinely used for Pap testing. Other Hologic diagnostic tests that use ThinPrep specimens and are cleared by the FDA for use on the Panther system include the Aptima Combo 2 assay for chlamydia and gonorrhea, and the Aptima Trichomonas vaginalis assay.

The Aptima HPV assay has been approved for two uses:

  • To screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
  • To use adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.

The Aptima HPV assay was CE-marked in 2008 and received FDA approval on the Hologic high- throughput Tigris system in 2011.

For more information about Hologic's molecular diagnostic technology, please visit www.hologic.com or www.gen-probe.com.

About Hologic, Inc.

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women. The Company operates four core business units focused on diagnostics, breast health, GYN surgical and skeletal health. With a comprehensive suite of technologies and a robust research and development program, Hologic is committed to improving lives. The Company is headquartered in Massachusetts.

Hologic, Aptima, Aptima Combo 2, Panther, ThinPrep, and Tigris and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statement Disclaimer

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic's Aptima assays, and its Panther system. There can be no assurance the assays and system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. 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 the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.

1 Doorbar, J. 2006. Molecular biology of human papillomavirus infection and cervical cancer. Clin Sci (Lond). 110(5):525-41.

2 Monsonego J., F.X. Bosch, P. Coursaget, J.T. Cox, E. Franco, I. Frazer, R. Sankaranarayanan, J. Schiller, A. Singer, T.C. Wright Jr, W. Kinney, C.J. Meijer, J. Linder, E. McGoogan, and C. Meijer. 2004. Cervical cancer control, priorities and new directions. Int J Cancer. 108(3):329-33. Erratum in: Int J Cancer. 108(6):945.

3 Walboomers, J. M., M.V. Jacobs, M.M. Manos, F.X. Bosch, J.A. Kummer, K.V. Shah, P.J. Snijders, J. Peto, C. J. Meijer, N. Munoz.1999. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 189:12-19.

 

Contacts




Marianne McMorrow
Global PR and Advertising Publicist                              

Hologic, Inc.          

Marianne.McMorrow@Hologic.com

Tel: +1 781 999 7723  

Julie Cole
Marketing Communications Manager

Hologic, Inc.

Julie.Cole@Hologic.com
Tel: +1 858 410 8986                                               

 


'/>"/>
SOURCE Hologic, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Novogen Board Approves US$4 Million Investment In Marshall Edwards Rights Offering
2. FDA Approves NDA Supported By MedAvante Central Ratings
3. Cardinal Health Board Of Directors Approves Cash Dividend; Authorizes New $750 Million Share Repurchase Program
4. FDA Approves Neuralstem To Treat Final Cohort In NSI-189 Phase Ib Trial In Major Depressive Disorder
5. Specialty Pharmacy Certification Board (SPCB) Approves Content for Certified Specialty Pharmacist (CSP) Certification Exam
6. Aushon to Launch New Multiplex Immunoassay Platform
7. New Data Support Role of Prometheus Laboratories Novel Assay in Optimizing IBD Treatment Management
8. Omega Laboratories Applauds the Adoption of Enzyme Immunoassay (EIA) by Major Hair Testing Laboratories
9. New Molecular Assay Allows Healthcare Facilities to Simplify Active Surveillance Testing for Deadly Superbug
10. AIT Bioscience Taps Ligand Binding Assay Expert Dr. Ron Bowsher as Senior Research Advisor
11. ChanTest Awarded $1 Million Grant for Predictive Assays using Stem Cell-Derived Human Cardiomyocytes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... April 29, 2016 Acquisition ... Sciences, Product Development Capabilities in North ... Base . Indegene ( http://www.indegene.com ... the acquisition of Skura Corporation,s life science business. ... adaptive sales enablement technology for life science organizations ...
(Date:4/28/2016)... 2016  While Abbott,s announced purchase of St. ... repair and stent business, healthcare research firm Kalorama ... firmly into patient monitoring.  Kalorama said that patient ... areas, with double-digit growth expected the next 5 ... Remote Patient Monitoring . Abbott Laboratories agreed ...
(Date:4/28/2016)... , April 28, 2016 ... insights on healthcare, announced today that it has been ... Cool Vendor in Life Sciences, 2016, ... 2016.  The report focuses on life-science- oriented analytics, algorithms ... from patients and doctors, confirm medication ingestion, and analyze ...
Breaking Medicine Technology:
(Date:5/2/2016)... Fla. (PRWEB) , ... May 02, 2016 , ... ... fat,” wraps itself around major organs, such as the kidneys, liver and pancreas. ... Robert Drapkin, M.D ., a board-certified physician in Internal Medicine, Medical Oncology and ...
(Date:5/2/2016)... ... May 02, 2016 , ... According to an American Psychological Association ... sexually abused before the age of 18. Of those who survive, many still face ... others. , In her new book, Lyah! Lyah! Pants on Fyah!, she shares ...
(Date:5/2/2016)... ... , ... TeleMedCo™, a new company developing real time technology ... rapid diagnosis, triage and admission of patients leveraging IBM Watson’s software and healthcare ... the first time at GENBAND’s Perspectives16 conference. , TeleMedCo selected GENBAND’s Kandy ...
(Date:5/2/2016)... ... ... Dr. Jonathan Kulbersh of Carolina Facial Plastics isn’t surprised that Charlotte, NC, the city where ... 5 US Cities with the Highest Plastic Rates .” The other cities that made ... calculated using a survey by RealSelf and combining that data with the number ...
(Date:5/2/2016)... ... 2016 , ... For many artists, the act of blending paint is based ... a science. , Using the new, highly precise METTLER TOLEDO ML204T balance to ... and meaning to his works. What’s more, it has allowed him to recreate these ...
Breaking Medicine News(10 mins):