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

ts 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
'/>"/>

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:8/21/2014)... YORK , August 21, 2014 ... Israeli subsidiary, BreedIT Ltd., the exclusive worldwide license ... software for plant breeders and researchers, today is ... a joint venture with Seach Ltd, a leading ... formed to research and develop new breeds of ...
(Date:8/21/2014)... 2014  ACI Clinical ( www.aciclinical.com ) announces ... Committees. Using this solution, trial sponsors ... standard costs and receive the same expertise that ... services. Leveraging a decade of DMC ... development, statistical programming and meeting facilitation), ACI analyzed ...
(Date:8/21/2014)...  Henry Schein, Inc. (NASDAQ: HSIC ), the ... office-based dental, animal health and medical practitioners, announced today that ... , September 4, 2014 – Baird 2014 Healthcare ... p.m. ET , September 8, 2014 – ... , NY at 1:25 p.m. ET Henry ...
Breaking Medicine Technology:BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 2BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 3BreedIT Ltd. and Seach Ltd. Form KanaboSeed to Develop New Medical Cannabis Varieties 4ACI Clinical: Innovation and Savings in Data Safety Monitoring Committees 2Henry Schein To Present At Two Investor Conferences In September 2
... Pharmaceuticals, Inc. (Nasdaq: TRBN ) today announced financial ... Sept. 30, 2009. , (Logo: http://www.newscom.com/cgi-bin/prnh/20090320/TRUBIONLOGO ) , ... , Revenue for the third quarter and ... and $12.8 million, respectively, compared with $3.8 million and ...
... SADDLE RIVER, N.J., Nov. 5 PDI, Inc. (Nasdaq: PDII), ... to U.S. pharmaceutical companies, today reported financial and operational results ... Commenting on today,s announcement, Nancy Lurker, Chief Executive Officer of ... were lower than last year by approximately 14%. Higher ...
Cached Medicine Technology:Trubion Pharmaceuticals, Inc. Reports Third Quarter and Nine Months 2009 Financial Results 2Trubion Pharmaceuticals, Inc. Reports Third Quarter and Nine Months 2009 Financial Results 3Trubion Pharmaceuticals, Inc. Reports Third Quarter and Nine Months 2009 Financial Results 4Trubion Pharmaceuticals, Inc. Reports Third Quarter and Nine Months 2009 Financial Results 5Trubion Pharmaceuticals, Inc. Reports Third Quarter and Nine Months 2009 Financial Results 6Trubion Pharmaceuticals, Inc. Reports Third Quarter and Nine Months 2009 Financial Results 7PDI Reports 2009 Third Quarter Financial Results 2PDI Reports 2009 Third Quarter Financial Results 3PDI Reports 2009 Third Quarter Financial Results 4PDI Reports 2009 Third Quarter Financial Results 5PDI Reports 2009 Third Quarter Financial Results 6PDI Reports 2009 Third Quarter Financial Results 7PDI Reports 2009 Third Quarter Financial Results 8PDI Reports 2009 Third Quarter Financial Results 9PDI Reports 2009 Third Quarter Financial Results 10PDI Reports 2009 Third Quarter Financial Results 11
(Date:8/21/2014)... According to a new market report published ... Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012 ... at USD 236.1 million in 2011 and is estimated ... 2018 at a CAGR of 6.3% from 2012 to ... http://www.transparencymarketresearch.com/fundus-cameras.html . , Fundus cameras market growth in ...
(Date:8/21/2014)... 21, 2014 It's a terrible thing when ... to a serious substance abuse issue. When that happens to ... action is getting reliable help from the qualified substance abuse ... facility isn’t always easy for those young adults living in ... significant addiction issue. , Thankfully there is a new ...
(Date:8/21/2014)... The worlds of personal care and yoga are ... grab free products. BaliniSports will be shipping ... with all qualifying purchases for a limited time. “The ... apparel is simply perfect,” said Ada Hung, founder and ... brands is intended to give people in the yoga ...
(Date:8/21/2014)... Rockville, Maryland (PRWEB) August 21, 2014 ... developed with guidance from Lockton Companies and builds ... the industry’s only cellular glucometer, combined with Accountable ... and robust data analytic capabilities and adds a ... provider care, including eye exams, provider visits, HbA1c ...
(Date:8/21/2014)... Tibet has long been a desired ... kingdom. Prayers flags whip in the wind against ... rumble of chanting monks fill the otherwise silent temples. ... access to Tibet is challenging due to high elevation ... prove to be daunting for even the most experienced ...
Breaking Medicine News(10 mins):Health News:Fundus Cameras Market: Product Type- Mydriatic, Non-Mydriatic, Hybrid and ROP Cameras; End Users- Hospitals, Ophthalmology Clinics and Ophthalmic & Optometrist Offices 2Health News:Young Adults in Pompano Beach, FL Are Finding Success With Innovative New Helpline 2Health News:Tom's of Maine Partner up with BaliniSports Yoga Apparel 2Health News:Accountable Health Expands Diabetes Management Solutions to Address Gaps in Provider Care 2Health News:Accountable Health Expands Diabetes Management Solutions to Address Gaps in Provider Care 3
... HealthDay Reporter , MONDAY, Aug. 30 (HealthDay News) -- ... summer months, new research shows. In a study using ... from Brigham and Women,s Hospital in Boston found that new ... spring and summer compared to colder times of the year. ...
... women during visits to family planning clinics whether their ... a type of intimate-partner violence called reproductive coercion ... continue to experience such pressures, according to a new ... School of Medicine. Young women who recently experienced ...
... A new study from Hasbro Children,s Hospital finds visits ... team sports have increased dramatically over a 10-year period, ... football. The number of sports-related concussions is highest in ... is significant and rising. The study is published in ...
... Alan Mozes HealthDay Reporter , SUNDAY, Aug. ... low-dose omega-3 fatty acid supplements don,t appear to gain ... research cautions. In fact, neither low doses of ... found in fish oil, nor of alpha-linolenic acid (ALA), ...
... Dr. Hernn Makse, professor of physics at The City College ... way that information and infectious diseases proliferate across complex networks. ... contrary to conventional wisdom, persons with the most connections are ... where someone is located in a network," said Professor Makse ...
... Austin,s new Health Information Technology program has received $2.7 ... and Education for Health Information Technology (PURE HIT) consortium ... of Health and Human Services Office of the National ... graduated its first class of 54 students this summer. ...
Cached Medicine News:Health News:Multiple Sclerosis Changes With the Seasons 2Health News:Multiple Sclerosis Changes With the Seasons 3Health News:Study finds asking about pregnancy coercion and intimate-partner violence can reduce their incidence 2Health News:Study finds asking about pregnancy coercion and intimate-partner violence can reduce their incidence 3Health News:Concussions in young athletes on the rise 2Health News:Concussions in young athletes on the rise 3Health News:Low-Dose Omega-3 Fatty Acids Don't Protect Heart Patients 2Health News:Low-Dose Omega-3 Fatty Acids Don't Protect Heart Patients 3Health News:Location determines social network influence, CCNY-led team finds 2Health News:Location determines social network influence, CCNY-led team finds 3Health News:Health IT program at the University of Texas at Austin receives $2.7 million in federal funding 2Health News:Health IT program at the University of Texas at Austin receives $2.7 million in federal funding 3
...
...
Conforms to the convexity of the lens providing easier access to anterior capsule. Reduces pontential of corneal touch. 25G x 5/8in (.50 x 16mm)...
... Unique product designed for LASIK surgery ... Designed to irrigate the corneal interface ... easy insertion under the flap and ... ports provide multi-directional irrigation. Two 25G ...
Medicine Products: