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 tes
'/>"/>

SOURCE Hologic, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

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:1/15/2014)... -- ChinaMarketResearchReports.com adds "China Orthopedic Instrument Industry Report, 2013-2015" ... (Photo: http://photos.prnewswire.com/prnh/20140115/MN46792 ) Benefiting from aging ... China,s orthopedic instrument industry has seen rapid ... from 3.28 billion yuan in 2006 to 9.85 billion ...
(Date:1/15/2014)... RAPIDS, Mich. , Jan. 15, 2014 As health ... the flu virus, select Meijer pharmacies in Michigan ... strep throat to eligible patients, enabling Meijer pharmacists to administer ... strict protocol set by a physician participating in the study. ...
(Date:1/15/2014)... , Jan. 15, 2014  Celsion Corporation (the "Company") (NASDAQ: ... commitments from institutional investors to purchase an aggregate of ... an at-the-market registered direct offering, led by a dedicated ... definitive purchase agreements with these investors pursuant to which ...
Breaking Medicine Technology:Orthopedic Instrument Industry in China Markets Forecast to 2015 2Orthopedic Instrument Industry in China Markets Forecast to 2015 3Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 2Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3
(Date:4/23/2014)... 2014Men whose testosterone falls below normal levels are more ... and have heart disease and type 2 diabetes. A ... for further testing and possible treatment is described in ... a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. ... of Men,s Health website at http://www.liebertpub.com/jmh . ...
(Date:4/23/2014)... (April 23, 2014) The American Gastroenterological Association ... 2014 AGA Research Scholars. The AGA Research Scholar ... to develop independent and productive research careers in ... Awards fund an additional year allowing for three ... to supporting junior faculty who are paving the ...
(Date:4/23/2014)... - In a country as wealthy as the United States, ... seniors do not have access to adequate food due to ... insecure. , Recent research at the University of Illinois ... (NHANES) revealed that the seniors who are dealing with hunger ... "In 2011, 8.35 percent of Americans over age 60 faced ...
(Date:4/23/2014)... concerned about an increase in adolescents, marijuana use following ... of relief. According to a new study at Rhode ... from states with and without medical marijuana laws, legalizing ... adolescents. The study is published online in advance of ... , "Any time a state considers legalizing medical ...
(Date:4/23/2014)... the depletion of self-control, according to research published in ... for Psychological Science. , Self-control can be difficult ... on a boring textbook are hard things to do. ... Exerting self-control for a long period seems to "deplete" ... , "It is as if self-control is a limited ...
Breaking Medicine News(10 mins):Health News:AGA announces 2014 Class of AGA Research Scholars 2Health News:More Americans in their golden years are going hungry 2Health News:RI Hospital physician: Legalizing medical marijuana doesn't increase use among adolescents 2Health News:ADHD drug may help preserve our self-control resources 2
... HealthDay Reporter , WEDNESDAY, April 18 (HealthDay News) ... around more -- even gardening or puttering around the ... than more sedentary seniors. The study doesn,t ... an age-related degenerative brain disease. It,s possible that another ...
... Agency and University of British Columbia have identified new ... disease is diagnosed and form the basis of next-generation ... completely new categories based on the genetic fingerprint of ... insight into breast cancer biology, allowing doctors to predict ...
... April 18 (HealthDay News) -- Worrying may have co-evolved ... new research suggests. For the study, researchers looked ... them to a group of 18 healthy volunteers without ... high intelligence were associated with brain activity measured by ...
... favors the well prepared," says Paul S. Auerbach, MD, ... Society and editor of Wilderness Medicine, 6th Edition, recently ... vacations or outdoor excursions can become familiar with adverse ... "Severe weather, wild animals, rugged terrain, and equipment ...
... (HealthDay News) -- Long-term exposure to fine-particle air pollution ... lung and heart disease, stroke and diabetes, a new ... compared air-quality data with hospital admission records on all ... New England hospitals between 2000 and 2006. The ...
... By Amanda Gardner HealthDay Reporter , ... has chosen the middle ground with its new drug ... approach, unveiled Tuesday, rejects both the harsh "war ... offenses, and the push to legalize illegal drugs. ...
Cached Medicine News:Health News:Everyday Activities Might Lower Alzheimer's Risk 2Health News:Everyday Activities Might Lower Alzheimer's Risk 3Health News:Scientists rewrite rulebook on breast cancer in landmark global study 2Health News:Scientists rewrite rulebook on breast cancer in landmark global study 3Health News:Wilderness Medicine founder offers health tips for summer season 2Health News:Wilderness Medicine founder offers health tips for summer season 3Health News:More Smog Might Mean More Hospitalizations 2Health News:White House Drug Policy Shifts Strategy 2Health News:White House Drug Policy Shifts Strategy 3
Infusion Cannula, 4.0mm....
Subretinal Injection Cannula, Curved; 20g (0.90) x 1" (25mm); Tip Extension: 3mm, 32g (0.23); Angled at 35°....
Subretinal Fluid Cannula, Straight; 20g (0.90) x 1-1/2" (38mm); 12mm Flexible Tubing Extends 6mm Beyond Tip....
Micro Vitreoretinal Cannula; Angled; 20g (0.90) x 1" (25mm); Tip Extension: 3mm, 32g (0.23); Angled at 65°, 1mm from Tip....
Medicine Products: