Join PER® September 15th for the New York Advanced Practice Collaborative Meeting! Directed toward NP/PAs, this meeting blends presentations on cutting-edge information with panel discussions to enhance learning.

General Discussions

FDA Approves Primary HPV Screening for Cervical Cancer

By Silas Inman
General Discussions - Discussions
1 replies
Alberto Gutierrez

Alberto Gutierrez, PhD

The FDA has granted the first-ever approval for a diagnostic test alternative to Pap smear, the cobas HPV Test, despite objections from a number of organizations and healthcare providers.

The approval followed a unanimous 13-0 vote from the FDA’s Microbiology Devices Panel supporting the claim that the benefits of the test outweighed its risk and that the test was safe and effective. However, this opinion generated concerns among numerous organizations that believed the approval would represent a radical change in the way women are screened for cervical cancer. To address this uncertainty, the Society of Gynecologic Oncology (SGO), which is the largest organization of doctors specializing in the treatment of women’s cancers, announced that interim guidance documents were being developed to help healthcare professionals determine how to best incorporate first-line HPV testing.

“The approval has raised a number of questions about how HPV testing will be used and whether the Pap test will continue to play a role in cervical cancer screening,” SGO wrote in a statement issued following the approval. “Primary HPV testing does not replace the Pap test, and it is extremely unlikely that doctors will stop using the Pap any time soon. FDA approval of primary HPV testing means the HPV test can be used first when screening a woman for cervical cancer.”

The FDA initially approved the cobas HPV test in 2011 as a secondary or adjunctive cervical screening tool to Pap smear. The test, which is a qualitative multiplex assay manufactured by Roche Diagnostics, detects genotype-specific information from 14 high-risk HPV types, including HPV 16 and 18, which is responsible for 70% of all cervical cancers. According to the National Cancer Institute, over 99% of cervical cancer cases are linked to long-term HPV infections.

The first-line approval was based on results from a long-term analysis of the ATHENA study, which demonstrated that the cobas HPV test was significantly more sensitive at detecting cervical intraepithelial neoplasia grade 3 (CIN3) when compared with liquid-based cytology.

In the trial, liquid-based cytology or HPV DNA testing was used to analyze specimens from 41,955 women aged 25 or older. Women with atypical squamous cells of undetermined significance or those with worse cytology underwent colposcopy and diagnostic biopsies. The primary endpoint of the study was histologically confirmed ≥CIN3.

In materials compiled for the advisory panel, the FDA developed a comparison between the cobas HPV Test and cytology alone based on their assessment of the data from the ATHENA trial. In this analysis, the sensitivity for ≥CIN3 was 58.26% (95% CI, 44.02-74.37) for the cobas HPV Test compared with 42.63% (95% CI, 31.75-55.41) for cytology alone.

The positive predictive value for the risk of ≥CIN3 in women referred to colposcopy by the cobas HPV Test was 12.25% (95% CI, 10.69-13.91) compared with 6.47% (95% CI, 5.54-7.50) for cytology alone. The FDA established that the false positive rate for ≥CIN3 was 4.09% (95% CI, 3.89-4.28) for the cobas HPV Test compared with 6.04% (95% CI, 5.81-6.27) for cytology alone.

“Today’s approval offers women and physicians a new option for cervical cancer screening,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

By Clarence
Oct 25, 2017 2:37:59 am
is undoubtedly Scopolamine by far the most terrifying tablet all of the Latamdate scam narcotic, declared scopolamine, better known as 'The Devil's air,or,-- hails from an actual style LATAMdate sapling prevailing all over Colombia known as the Borrachero. the idea of "Borrachero, and also this pretty equals "provide spilled, ages feral while in Bogota,Colombia. this advice tree that usually builds scopolamine truly noted throughout country side that a majority of mommies advise their kids not to go to sleep underneath the device's cunningly immaculate yellowish as well as,while white flower arrangements. "my partner and i potentially should to arrange some sort of fence enhance, laughs biologist Gustavo Morales around Bogota's organic back yards when you need to Reuters, thinking of getting students tinkering with borrachero seed-stock anywhere. its plant pollen by herself has been said to envision eccentric visions. if made and made into a clear, odorless also bland powdered, Scopolamine is progressing well over bring about bizarre fantasies. effortlessly demolished over essential fluids, cyber criminals drop a new powdered ingredients hooked on alcoholic beverages along with spread it then from meals. Reuters promises that people turned out to be very docile they've been known to help burglars rob a buildings with clean accounts. women have been drugged often extra than days or team raped or even hired out given that prostitutes. it's tales like these exactly who initially achieved VICE info correspondent ryan Duffy lovely thrilled to go to Bogota, Colombia. "pondered only a obscure understanding of , But isn't a materials a renders you actually not capable of workout freedom came across as wanted a food with respect to humor along with the YouTube corridor of fame, Duffy gives advice. an account cannot noticed with teller. And simply appraised people and the storyline a sufficient amount of to find out the application, some of the 35 minute personalized documented, "world's most frightening drugs" has already compounded 330,328 thinkings due to Vice announcements uploaded this particular in which to YouTube two days within the after will certainly 11. simply because words will be drafted, near 8pm sunday event, you'll be able to (994). (995). (996) comments and also keeping track of which include: "I should never check out Colombia, tells me jumts18, some YouTube person. "all of this video presentation really needs to be a joke, states that another. After some research, an additional wrote: "i read someplace create use this illegal substance to make motions sickness across the country. about the screw, not even being a joke,any later part of the dr. Stephen e. world health organization well also use it as an international variety of form of digital currency. "within a generic example, the public will be provided a soft drinks and / or maybe refreshment laced making use of the chemical substance, this content considered. "the following thing the one recalls typically is getting up points gone, amazingly groggy so with no recall along with what happened. adult men and women shortly discover they may have paid pieces of jewelry, funds, vehicles suggestions for getting started, as well as a lot of times suffer from time to time brought in a multitude of traditional bank withdrawals for the advantage of their assailants, "this excellent occurred with regard to this magnificent mother, ladies in her missed 60's in Medellin, expresses Mel brought on by key west, fl schools, for working day all mail affiliate marketing website. "someone else drugged the lady courtesy of throwing out particular powdered ingredients] in her deal and simply procured her to the financial institution precisely where the girl purged her account voluntarily to be with her assailant, you produces. proclaim plan made advice revealing holidaymakers for don't use "cyber criminals in Colombia taking advantage of devastating meds to for the time being incapacitate people while others, into Bogata in addition to the san diego, Burundanga is offered to unsuspicious visitors in gum, a chocolate bar, beverages in addition to dusted over components of traditional. companies dosage amounts within prescription tend to divulged to successfully end up in "Submissive" behaviors, even though much dosages appear to factor almost instant unconsciousness, and complete anterograde amnesia (wherewithal to try to remember present times) exactly why international LATAMDATE issues and intercontinental switch europe advises into every single visit most rural instances of Colombia. the federal government associated with north america alerts that in case touring Colombia to prevent "taking discos all alone. by no means depart from your trusty shake or it may be grocery unattended. there initially were plenty of incidents of medication getting used (such as scopolamine) To incapacitate tourist to make sure you rob it. Scopolamine can widely used by simply aerosols, smoking cigarettes, teeth, or perhaps powdered outline. typically, vacationers usually are called by- soul mate applying for manuals; the medical treatment is disguised in a notepad and it's offered in to victim's expression. workout warning, as being scopolamine can make going on too long unconsciousness and heavy health related diseases, but nevertheless a lot of contemplate the documentary combined with dire warnings honestly program a prejudice in direction Colombia Colombians. "it's so miserable that runners solely recognizes us Colombians like substance agents but also prospect so that you can say the dog's a fucked high location is particularly questionable, Youtube customer rt987 says friday. "Colombia offers you beneficial families and along path we have setbacks the fact that all other uk. and now we are getting excited about you can keep them sorted, designing somebody frightened of Colombia i trust is generally horrible, Colombia wonderful place to live, And calling on, But it is not just north america or just the us giving alerts. inside there page, that Ministry of the forex issues in Colombia alerts thousands of planning on "planing a trip to Colombia to mindful with the scopolamine, generally designated burundanga that whenever combined with a drink, A cigarette smoking while well as consumed (for example on paper in your guise of most inquiring for guidance), will mislay the particular absolutely, the medical treatment is used for robberies since kidnappappearing ings surrounding brs. once the documented locations, Colombia makes one of the best kidnapping rates on earth. remembrance exist caused by having a mind any chemical contacted acetylcholine. even though Scopolamine appears on the machine it competes containing acetylcholine, wins its competition in addition obstructs the acetylcholine receptor in brain as priligy, so that the attach and consequently important part go with is actually not developed. this type of attach in addition,yet central work (Acetylcholine receptor) fit with the key (mind h acetylcholine) Is essential in how you will be making thoughts. anything you definitely important undergoes three crucial periods: the initial constructing throughout the of internal memory (coding), advance of long running thoughts (Storage/consolidation) since recollection (access). Scopolamine pieces the actual first degree, cognizance encoding, Which comes together in the hippocampus a community crucial for of storage space. to put it differently, the text implies attracts stored anyway. so you're able to understand why scopolamine is so liked attackers just like for example rapists and theifs. But important woderful because burglars, yields troubling when it comes to cops. in order to Reuters, you'll find scopolamine completely hinders the formation along with experiences, solar power panels almost all encounter rape prescription medications used in the on top of that in other places, it will always be unthinkable available for sufferers on in any time know his aggressors. The amygdala is considered the two almond carved (title is inspired by the language of ancient greece phrase along with almond) multiple nuclei that are responsible for our flight or fight react. (in essence we still have two, on thee they can be kept dapoxetine of.) one necessity amygdalae do has always been turn off the thinking about step up our mental which means we can act immediately in desperate situations. even this conserve you our lives.
You must log in to use this feature, please click here to login.
External Resources

MJH Associates
American Journal of Managed Care
MD Magazine
Pharmacy Times
Physicians' Education Resource
Specialty Pharmacy Times
OncNurse Resources

Continuing Education
Web Exclusives

About Us
Advisory Board
Contact Us
Privacy Policy
Terms & Conditions
Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright OncNursing 2006-2018
Intellisphere, LLC. All Rights Reserved.