Navigation Links
FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologic's Panther System
Date:11/7/2013

BEDFORD, Mass., Nov. 7, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostic 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 the Aptima HPV 16 18/45 genotype assay for use on the Company's fully automated Panther system. The Aptima HPV 16 18/45 genotype assay is performed using Hologic's ThinPrep liquid cytology specimen and is intended to be tested from the same sample that has already received Aptima HPV assay positive results.

Hologic's Aptima HPV 16 18/45 genotype assay is the first test FDA‐approved for genotyping human papillomavirus (HPV) types 16, 18 and/or 45. Recent data suggests that although cervical cancer incidence has decreased since the 1970s, the prevalence of adenocarcinoma cases has risen approximately 32 percent in the same time frame.1 Detection of these HPV types as part of reflex testing may help clinicians identify up to 94 percent of all cervical adenocarcinomas.2

Although HPV genotype 45 is fairly uncommon, identified in only 0.4 percent of women with normal cytology,  data indicates that it is the third most common HPV genotype in invasive cancer. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates. Studies have shown that HPV types 16, 18 and 45 are more likely to be integrated into the human genome than are the other HPV types, and tumors with these genotypes may present earlier.2

"The addition of the Aptima HPV 16 18/45 genotype assay to the Panther menu further 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," said Rohan Hastie, Ph.D., Hologic's Group Vice President – Diagnostics.

The Aptima HPV 16 18/45 genotype assay is intended to test specimens from women with Aptima HPV assay positive results.  The FDA has approved the test for two uses:

  1. In patients 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
  2. In patients 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

The Aptima HPV 16 18/45 genotype assay was CE marked in December 2011 and received FDA approval on the Hologic high-throughput Tigris system in October 2012.

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 diagnostic 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 breast health, diagnostics, 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, Panther, ThinPrep, 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.Contacts:Marianne McMorrowJim CulleyGlobal PR and Advertising PublicistSenior Director of MarketingHologic, Inc.Hologic, Inc.Marianne.McMorrow@Hologic.comJim.Culley@Hologic.comTel: +1 781 999 7723Tel: +1 781 999 7583

  1. Saslow D, et al. J Low Genit Tract Dis 2012;16(3):175-204.
  2. de Sanjose S, et al. Lancet Oncol 2010; 11(11): 1045-56.

'/>"/>
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. FDA APPROVES APTIMA HPV ASSAY FOR USE ON HOLOGICS PANTHER SYSTEM
7. FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults
8. FDA approves drug tested by Scottsdale Healthcare and TGen
9. Aethlon Medical Reports Undetectable Hepatitis C Virus (HCV) in Genotype 1, Genotype 3, and Genotype 5 Patients Treated with Hemopurifier® Therapy
10. Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C
11. ADial Pharmaceuticals Announces Agreement With FDA For Phase III Trial Of AD04 For Alcohol Use Disorder In Patients Of Targeted Genotypes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/8/2017)... Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on ... the second quarter ended June 30, 2017. ... to date: Continued ... lead project, BL-8040: Announced plans to ... stem cell mobilization treatment for autologous bone-marrow transplantation in ...
(Date:8/7/2017)... -- Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation,s largest independent specialty ... 2017.  All comparisons, unless otherwise noted, are to the quarter ... Second Quarter 2017 Highlights include: ... of 3.5% Total prescriptions dispensed of 220,000, ... versus 7.6% Gross profit per prescription ...
(Date:8/2/2017)... 2, 2017 Fenita J. Caldwell ... a Pinnacle Lifetime Professional in the Field of ... at Turing Pharmaceuticals, AG. Her skills and areas ... building.                ... years of experience as a highly successful sales ...
Breaking Medicine Technology:
(Date:8/18/2017)... ... August 18, 2017 , ... Hernandez Insurance Agencies, ... communities throughout the greater DC region, is inaugurating a “New Leash On Life” ... animals and training them to be companions for veterans in need. , The ...
(Date:8/18/2017)... (PRWEB) , ... August 18, 2017 , ... ... and financial planning assistance that serves communities throughout southern Florida, is working to ... provide scholarship assets to children from low income families. , The Take Stock ...
(Date:8/18/2017)... ... ... The Golseth Agency, a Texas based insurance management and financial planning assistance ... campaign organized to provide support to Christina Upchurch and her two children after the ... children returned from out of town to find her husband passed away and their ...
(Date:8/18/2017)... ... ... and Overseer at The House of Yahweh in Abilene, Texas, has released a new publication ... mother of the Savior whom the world calls “Mother Mary”. Yisrayl says when compared to ... this historical woman. , “The world bows, kisses the feet of, cries out to ...
(Date:8/18/2017)... ... August 18, 2017 , ... 800response, ... and monitoring solutions, announced today the launch of a redesigned corporate website, ... and aesthetic, fully responsive design, and an enhanced search directory for businesses and ...
Breaking Medicine News(10 mins):