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Page 2 of 3

labroots

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THE LAB

Unable to find a lab that runs this test in the greater Louisville area, UofL is now sending out its

tests to a lab in a neighboring state—Tennessee, to be exact.

“The HPV test alone, for a certain group of women, is a [more] sensitive method of getting the

correct snapshot on that patient’s cervical health than a combination of other tests,” such as

doing a Pap and a co-test says board-certified cytopathologist Bradly D. Clark, MD, medical

director, Women’s Health Laboratories, Poplar Healthcare/Women’s Health Laboratories,

Memphis, Tenn. “It’s very efficient in its design in that you just do one test and have a better

sensitivity than you would by doing cytology.”

The primary HPV screening tool, developed by Roche and performed on its cobas molecular

platform, was approved for FDA use in early 2014. This screening method looks for presence

of HPV nucleic acid in patients 25 years or older. Fourteen subtypes of high-risk HPV are

detected. The two subtypes known to play the largest role in cervical dysplasia—HPV 16 and

HPV 18—are discerned by the cobas method. Simultaneously, the cobas system also provides

pooled-results detection of twelve other high-risk subtypes. The molecular testing uses a small

portion of the liquid-based ThinPrep Pap test, which is standard in many provider settings.

In this new screening scheme, a patient who is negative for the HPV screen is placed on the

provider’s standard screening interval(s). A patient who is found positive for either HPV 16 or

HPV 18 is immediately referred to colposcopy. For the patient who is positive for the pooled

HPV 12 subtypes, a Pap slide is prepared and reviewed by the cytology department. The next

steps for that patient are driven by the reading of that slide. “In this new setting, a negative

cobas HPV primary screening test provides about twice the reassurance for a patient they’re

not going to develop a high-grade lesion in the next three years,” Clark says.

The medical profession, using cytology-based screening, has done a fantastic job of reducing

the amount of cervical dysplasia, Clark notes. “But we’re up against technology now, since

cytology has limitations,” he says. “Instead of co-testing [Pap slide plus HPV test], why can’t we

just shortcut the entire method? Start, instead, with just an HPV test.”

Pap screening schemes have seen several iterations in the past generation. First, we saw the

yearly Pap. Then came the attenuated interval, which spaced the Paps between every three

to five years, depending on the age of the patient. Yet another iteration was addition of co-test

(HPV test) to negative Pap test for patients 30 years or older.

For patients who are infected with a high-risk HPV, it generally it takes several years for it to

develop into something serious, such as a high-grade lesion or worse, into cancer. “So, if you

have that extended period of time, why would you Pap on a yearly basis?” Clark says. “This

rational Pap testing interval for patients 25 years or older, uses a more sensitive method versus

the ASC-US triage strategy we have used in the recent past. Instead, a positive cobas HPV test

identified those at greatest risk.

Despite his embrace of the new testing algorithm, Clark’s not ready to write an obit for

cytology just yet. “GYN cytology and the Pap slide are not going away,” he says. “The primary

screening by HPV is used for those age 25 and above. Pap slides will still be necessary for

those in a younger age group.

And further, slide interpretation will be necessary for the 12-pooled HPV positive, he says.

“We’ve got a better technology now, and so the idea of doing a yearly Pap slide—that

paradigm is being challenged—being replaced by a Pap every three or five years. Now there is

the arrival of the primary HPV screening,” Clark says.

Making the Change to Primary Screening for HPV

Page 1 of 3

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By Judy O’RourkeJanuary 26, 2015

Making the decision to move from co-testing to primary Human papillomavirus (HPV) screening was one thing. Implementing it has been another, for one medical group.

The University of Louisville Physicians-Family and Geriatric Medicine (UofL), Louisville, Ky, had contracted with one of the largest providers of diagnostic testing services in the United States in the past. They were forced to find a different lab when they decided to implement primary HPV screening alone for all women 25 years and older, and continue to screen with primary cytology and HPV triage for those 21 to 24 years.

THE FACILITY

Diane M. Harper, MD, MPH, MS oversees HPV testing at UofL, which includes three clinic sites: Cardinal Station Family Medicine offices, Newburg Family Medicine offices, and the Centers for Primary Care. The staff comprises some 44 providers in total (including residents). Harper says her goal was to change the standard of care for women’s health cervical cancer screening, and that meant opting for the only test approved by the FDA in 2014 for primary screening, the cobas HPV Test, from Roche Diagnostics.

“The benefits are our ability to better detect those women who are at real risk of having a CIN-3 lesion, and not identifying nondiseased women,” Harper says. “[The cobas HPV Test] has a high true-positive rate, with minimal false-positives identified.”(Invasive squamous carcinoma of the cervix is caused by a progression of preinvasive precursor lesions, cervical intraepithelial neoplasia (CIN), or dysplasia, with CIN-3 being considered severe.)

Harper, professor and chair of the Department of Family and Geriatric Medicine, University of Louisville, has more than 140 peer-reviewed, published works on this topic. She also holds joint appointments in the Departments of Obstetrics and Gynecology in the School of Medicine, Bioengineering in the Speed School of Engineering, and Epidemiology and Population Health and Health Promotion and Behavioral Health Sciences in the School of Public Health and Information Sciences; has served as an advisor to the World Health Organization for the past 15 years; and reviews research grants at the federal level for NCI, PCORI, AHRQ and the European Commission on Research, in addition to the Wellcome Trust, as well as others.

ORIGINAL ARTICLE

Making the Change to Primary Screening for HPV

Credit: National Cancer Institute (NCI)

This image is from the National Cancer Institute’s Building on Opportunities in Cancer Research: An Annual Plan and Budget Proposal for Fiscal Year 2016.

www.cancer.govSource: Schiller JT and Lowy DR. Understanding and learning from the success of prophylactic

human papillomavirus vaccines. Nat Rev Microbiol 2012; 10(10): 681-692.

Making the decision to move from co-testing to primary Human papillomavirus (HPV) screening was one thing. Implementing it has been another, for one medical group.

Making the Change to Primary Screening for HPVThe University of Louisville Physicians-Family and Geriatric Medicine (UofL),Louisville, Ky, had contracted with one of the largest providers of

TRENDING

April 15, 2015 | Written By: Jennifer Ellis

3a 41b 3100e

Making the decision to move from co-testing to primary Human papillomavirus (HPV) screening was onething. Implementing it has been another, for one medical group.

The University of Louisville Physicians-Family and Geriatric Medicine (UofL), Louisville, Ky, hadcontracted with one of the largest providers of diagnostic testing services in the United States in the past.They were forced to find a different lab when they decided to implement primary HPV screening alone forall women 25 years and older, and continue to screen with primary cytology and HPV triage for those 21to 24 years.

The facility

Diane M. Harper, MD, MPH, MS oversees HPV testing at UofL, which includes three clinic sites: CardinalStation Family Medicine offices, Newburg Family Medicine offices, and the Centers for Primary Care. Thestaff comprises some 44 providers in total (including residents). Harper says her goal was to change thestandard of care for women's health cervical cancer screening, and that meant opting for the only testapproved by the FDA in 2014 for primary screening, the cobas HPV Test, from Roche Diagnostics.

“The benefits are our ability to better detect those women who are at real risk of having a CIN-3 lesion,and not identifying nondiseased women,” Harper says. “[The cobas HPV Test] has a high true-positiverate, with minimal false-positives identified.”(Invasive squamous carcinoma of the cervix is caused by aprogression of preinvasive precursor lesions, cervical intraepithelial neoplasia (CIN), or dysplasia, withCIN-3 being considered severe.)

Harper, professor and chair of the Department of Family and Geriatric Medicine, University of Louisville,has more than 140 peer-reviewed, published works on this topic. She also holds joint appointments in theDepartments of Obstetrics and Gynecology in the School of Medicine, Bioengineering in the SpeedSchool of Engineering, and Epidemiology and Population Health and Health Promotion and BehavioralHealth Sciences in the School of Public Health and Information Sciences; has served as an advisor to theWorld Health Organization for the past 15 years; and reviews research grants at the federal level for NCI,PCORI, AHRQ and the European Commission on Research, in addition to the Wellcome Trust, as well asothers.

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This image is from the National Cancer Institute's Building on Opportunities inCancer Research: An Annual Plan and Budget Proposal for Fiscal Year 2016.

Image Credit: National Cancer Institute (NCI)

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Microbiology is the study of microscopic organisms. Although much is now known in the field of microbiology, somesuggest that we have studied only one percent of all of the microbes in any given environment. BioConference Livebrings the Microbiology research community together online through live video webcasts and real-time virtualnetworking. Attendees will have the chance to discover new concepts, tools and techniques that they can apply totheir own research and diagnosis. In addition, attendees can earn free CME and CE Credits. READ MORE

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Paul Flecknell, MA,VetMB, PhD -Professor/Director,Comparative BiologyCentre, The MedicalSchool, University ofNewcastle

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Angela Kerton,B.VetMed Cert LASMRCVS - Head ofVeterinary Services andCBS Training Unit,Imperial College London

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Dan Rothen, DVM -Research AssistantProfessor of Surgery,University of Miami

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CLINICAL & MOLECULAR DX

Bleached Lipids as New Biomarkers forSepsis?

Sepsis is one of the most serious medicalconditions that can scare even the best-traineddoctors. When sepsis hits, things move quicklyfrom bad to worse, resulting with death ifdiagnosis is slow and treatments are delayed.To quicken detection time and improve sepsisoutcome, a team of researchers from St ...

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Sleeping With a Pet Could Help YouSleep Better At Night

Do you allow your pets you sleep with you inthe same room when night time rolls around?There are some people that feel that pets in thesame bedroom can hinder the ability to sleep,whether it’s because they make noises, causeitching, hog the bed, or increase the heat of thegeneral area creating ...

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SpaceX Falcon 9 Rocket Remains Will BeDisposed of Properly

Less than two weeks ago, rocket remnants,measuring around 33 feet by 13 feet, from whatwere thought to be from SpaceX’s Falcon 9rocket that exploded in mid-air shortly aftertake-off during an attempt to re-supply theInternational Space Station earlier this year,were discovered off of the coast of ...

CLINICAL & MOLECULAR DX

TSRI Team Finds Unique Anti-DiabetesCompound Using Powerful New Drug-Discovery Method

Scientists from The Scripps Research Institute(TSRI) have deployed a powerful new drugdiscovery technique to identify an anti-diabetescompound with a novel mechanism of action.The finding, which appeared online ahead ofprint in Nature Communications, may ...

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Here's How Astronauts Feel About Seeing the Earth From AboveUnless you’re an astronaut, you probably don’t get to see Earth from upabove. Astronauts get a good view of the Earth from the InternationalSpace Station, and every single day, they watch the ...

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LABROOTS WILL:

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LABROOTS VIRTUAL EVENTS

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LabRoots Virtual Events Metrics: 800 Booth Visitors • 900 Webinar Viewers • 12,950 Attendees Per Event • 92% Attendees Enter Exhibit Hall • 3 Hours Spent Logged In

LabRoots 2016 2019 LabRoots 2016

GEOGRAPHY

JOB TITLE

Technician 24%Lab Management 21%

Medical Doctor/Specialist 13%Facility Manager/Director 11%

Research Scientist 10%Executive 8%

Educator/Faculty 7%Student 4%

Other 2%

TYPE OF ORGANIZATION

Clinical Laboratory 26%Hospital 17%

Medical Center 14%Research Institute 10%

Education Institution 10%Biotech Company 9%

Pharmaceutical 6%Government 5%

Other 3%

SPECIALTY

Clinical Chemistry 19%Immunology 17%

Microbiology 15%Infectious Disease 10%

Genetics & Genomics 10%Virology 9%

Oncology 8%Blood Screening 6%

Biochemistry 4%Other 2%

65% North America

18% Europe

9% Asia

1% Oceania

3% Africa4%

South America

MOLECULAR DIAGNOSTICSAPRIL 6-7, 2016PROJECTED REGISTRANTS: 15,000 | PROJECTED ATTENDANCE: 10,000

GEOGRAPHY

Genetics & Genomics 24%Bioinformatics 16%

Molecular Biology 14%Clinical Diagnostics 12%

Cancer Research 8%Molecular Diagnostics 8%

Biochemistry 7%Biotechnology 7%

Other 4%

SPECIALTY TYPE OF ORGANIZATION

66% North America

17% Europe

8% Asia

1% Oceania

4% Africa4%

South America

SCHEDULE OF EVENTS

Education Institution 28%Research Institute 25%Biotech Company 15%

Clinical Laboratory 10%Pharmaceutical 7%

Government 5%Hospital 3%

Non-Profit Organization 3%Medical Center 2%

Other 2%

GENETICS & GENOMICSMAY 11-12, 20162015 REGISTRANTS: 22,736 | 2015 ATTENDANCE: 13,941

JOB TITLE Research Scientist 26%

Lab Management 11%Genetic Counselor 10%

Technician 8%Educator/Faculty 8%

Student 8%Principal Investigator 7%

Post Doc 6%Facility Manager/Director 5%

Executive 4%Medical Doctor/Specialist 3%

Other 4%

LabRoots 2016 2221 LabRoots 2016

Clinical Microbiology 23%General Microbiology 18%

Immunology 11%Laboratory Testing 10%

Virology 9%Environmental Microbiology 8%

Infectious Disease 7%Food Microbiology 6%

Genetics & Molecular Biology 5%Other 3%

GEOGRAPHY

JOB TITLE

59% North America

22% Europe

8% Asia

2% Oceania

3% Africa6%

South America

Technician 23%Research Scientist 21%Lab Management 17%

Facility Manager/Director 12%Medical Doctor/Specialist 9%

Educator/Faculty 6%Student 5%

Executive 4%Other 3%

MICROBIOLOGY & IMMUNOLOGYSEPTEMBER 7-8, 20162015 REGISTRANTS: 16,570 | 2015 ATTENDANCE: 10,296

SPECIALTY

Clinical Laboratory 29%Research Institute 25%

Medical Center 9%Government 8%

Hospital 8%CRO 7%

Education Institution 6%Biotech Company 5%

Other 3%

TYPE OF ORGANIZATION

JOB TITLE

GEOGRAPHY

64% North America

19% Europe

9% Asia

2% Oceania

2% Africa4%

South America

SCHEDULE OF EVENTS

TYPE OF ORGANIZATION

Education Institution 18%Medical Center 18%

Research Institute 15%Clinical Laboratory 13%

Hospital 12%Biotech Company 9%

Pharmaceutical 5%Government 4%

Non-Profit 3%Other 3%

Research Scientist 25%Medical Doctor/Specialist 21%

Technician 14%Lab Management 12%

Student 10%Educator/Faculty 8%

Executive 8%Other 2%

CANCER RESEARCH & ONCOLOGYOCTOBER 5-6, 20162015 REGISTRANTS: 21,677 | 2015 ATTENDANCE: 12,954

SPECIALTY

Cancer Research 30%Oncology 16%

Genetics & Molecular Biology 15%Clinical Diagnostics 13%

Biochemistry 10%Biotechnology 6%

Chemistry 4%Bioinformatics 3%

Other 3%

LabRoots 2016 2423 LabRoots 2016

GEOGRAPHY

TYPE OF ORGANIZATION

Clinical Laboratory 24% Hospital 22%

Medical Center 20%Research Institute 12%

Education Institution 10%Biotech Company 7%

Government 5%Other 2%

SPECIALTY

60% North America

20% Europe

13% Asia

1% Oceania

2% Africa4%

South America

Technician 22%Lab Management 20%

Medical Doctor/Specialist 18%Research Scientist 16%

Executive 10%Educator/Faculty 7%

Student 4%Other 3%

JOB TITLE

Laboratory Testing 20%Molecular Diagnostics 13%

Clinical Diagnostics 10%Personalized Medicine 10%

Clinical Research 9%Point of Care 6%

Infectious Disease 6%Cancer Research & Oncology 6%

Informatics 5%Vitamin D 3%Nutrition 3%

Allergy 2%Cardiology 2%

Hematology 2%Diabetes 2%

Other 1%

CLINICAL DIAGNOSTICS & RESEARCHNOVEMBER 2-3, 20162015 REGISTRANTS: 25,374 | 2015 ATTENDANCE: 15,239

GEOGRAPHY

JOB TITLE

Veterinarian 23%Technician 21%

Research Scientist 15%Facility Manager/Director 14%

Lab Management 10%Educator/Faculty 8%

Executive 4%Student 3%

Other 2%

TYPE OF ORGANIZATION

Research Institute 28%Education Institution 20%

Veterinary Hospital 17%Biotech Company 15%

Pharmaceutical 8%Clinical Laboratory 4%

Hospital 3%Government 3%

Medical Center 2%

SPECIALTY

Animal Sciences 30%Veterinary Sciences 26%

Biotechnology 10%Neuroscience 8%

Genetics 7%Cancer Research 7%

Biochemistry 4%Molecular Biology 3%

Toxicology 3%Other 2%

64% North America

19% Europe

10% Asia

1% Oceania

3% Africa3%

South America

SCHEDULE OF EVENTS 2017 SCHEDULE OF EVENTS

LABORATORY ANIMAL SCIENCESFEBRUARY 8-9, 20172016 REGISTRANTS: 21,560 | 2016 ATTENDANCE: 13,378

LabRoots 2016 2625 LabRoots 2016

GEOGRAPHY

JOB TITLE

Lab Management 17%Technician 15%

Research Scientist 15%Medical Doctor/Specialist 13%Facility Manager/Director 9%

Executive 7%Regulatory Affairs 7%Educator/Faculty 6%

Chief Level Officer 5%Student 4%

Other 2%

TYPE OF ORGANIZATION

Medical Center 18%Clinical Laboratory 15%

Education Institution 13%Research Institute 11%

Hospital 11%Government 8%

Biotech Company 7%Pharmaceutical 6%

Non-Profit Foundations 5%Venture Capital/Investment Firms 3%

Other 3%

SPECIALTY

Cancer Diagnostics, Liquid Biopsies and Biomarkers 25%

Therapies For Rare Diseases 20%Next-Gen Sequencing 15%

Biobanking 15%Personalized Cancer Therapeutics 15%

Healthcare IT/Data Storage and Analytics 10%

65% North America

15% Europe

10% Asia

2% Oceania

4% Africa4%

South America

PRECISION MEDICINEFEBRUARY 22-23, 20172016 REGISTRANTS: 15,000 | 2016 ATTENDANCE: 10,000

GEOGRAPHY

TYPE OF ORGANIZATION

Research Institute 24%Education Institution 19%

Hospital 16%Clinical Laboratory 11%

Medical Center 10%Biotech Company 8%

Pharmaceutical 5%Government 4%

Other 3%

SPECIALTY

Neuroscience 34%Clinical Diagnostics 13%

Medicine 11%Biotechnology 8%

Cancer Research 8%Animal Sciences 8%

Toxicology 5%Biochemistry 4%

Genetics 4%Pharmacology 3%

Other 2%

JOB TITLEResearch Scientist 30%

Post Doc 11%Technician 10%

Principal Investigator 9%Psychologist/Psychiatrist 8%

Medical Doctor/Specialist 7%Lab Management 7%

Facility Manager/Director 5%Educator/Faculty 5%

Executive 3%Student 3%

Other 2%

59% North America

21% Europe

10% Asia

1% Oceania

4% Africa5%

South America

SCHEDULE OF EVENTS

NEUROSCIENCEMARCH 15-16, 20172016 REGISTRANTS: 23,045 | 2016 ATTENDANCE: 14,118

LabRoots 2016 2827 LabRoots 2016

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COMBINED CUSTOM ARTICLE AND INFOGRAPHIC CAMPAIGNS $10,000 Program Includes:

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LabRoots 2016 3029 LabRoots 2016

KEY EVENT PARTNER: $50,000*Including Hotspots

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products or services

• 3 virtual booths with preferred position in

exhibition hall (optional or additional speaker)

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3 x newsletters

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LabRoots 2016 3231 LabRoots 2016

CONTACT US

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