Novosanis Sampling Solutions

novosanis




sampling solutions



GAME-CHANGING

MEDICAL DEVICES









“Novosanis prospers in user-friendly and game-changing

medical device solutions for self-sampling and drug delivery.”









ABOUT US


Novosanis is a wholly owned subsidiary of OraSure Technologies Inc (NASDAQ: OSUR) and an
innovative developer and producer of medical devices improving the quality of diagnostics tests as
well as the accuracy of drug delivery for infectious diseases and oncology.
Novosanis is a Belgian privately-held ISO13485 certified company endorsed on multiple occasions

nationally and internationally for its solutions.
Novosanis prospers in user-friendly and game-changing medical devices meeting all regulatory and
quality requirements for self-sampling and drug delivery solutions that improve accuracy and
standardization while making handling easier, more consistent and more comfortable for the user.
















MEDICAL INNOVATIVE ISO 13485
RESEARCH MEDICAL DEVICES CERTIFIED



®



COLLI-PEE ® First-void urine collection


®
Colli-Pee is a patented, CE-marked and FDA listed sampling device that Colli-Pee®
efficiently captures first-void urine (first 20 mL of the urine flow). Standardized
volumetric collection of first-void urine allows for improved detection of infectious
diseases and early-stage cancer. Colli-Pee ® is user-friendly and can be used by
both men and women. The device can be shipped to people's homes as well as the
lab for testing purposes. To allow for storage and shipment of first-void urine at
room temperature for up to 7 days, the collector tube can be prefilled with our
proprietary UCM preservative.





Benefits Benefits
Diagnostic companies Users
and labs


Volumetric and standardized No need to interrupt the
first-void urine collection urine flow

Compatibility with diagnostic Allows hygienic and non-
assays invasive self-sampling
BE 1021230, patent granted
NL 2011416, patent granted
EP 2892434 B1, patent granted
Collector tube prefillable User-friendly and suited for US 9968336 B2, patent granted
with preservative men and women CN 201380047160.5, patent granted
PCT/EP2013/065853





Device applications






HPV
Human Papilloma Virus


Improving quality and
accuracy of STIs
diagnostic tests for Sexually Transmitted Infections
detection of:

Cancer
Early-stage cancer incl. prostate cancer








STANDARDIZED VOLUMETRIC USER-
FIRST-VOID SELF-SAMPLING FRIENDLY

Customizable device platform UCM preservative

As a trusted partner of diagnostic companies, Novosanis The collection tube of the Colli-Pee device contains a UCM
®
®
develops customized versions of Colli-Pee for improved (Urine Conservation Medium) buffer for a general preservation of
diagnostic accuracy and patient comfort. Bespoke tube design the urine during storage and transport. This will allow for storage
allows high throughput processing, centrifugation and at ambient temperature for up to 7 days. The combination with
workflow optimization. the UCM preservative is CE-marked.
















Colli-Pee ®
Successful automation
starts with sampling





UCM-Preservative


User instructions



3. Position the 5. Disassemble tube
1. Uncap tube device correctly from housing
























2. Assemble tube 4. Collect first- 6. Recap tube
and housing void urine



References Awards
Franceschi S et al. Internat. J of Cancer. 2016:139(3):518-26.. Best of PO Award 2013
Leeman A. et al. BJOG. 2017:124(9):1356-1363. IWT Innovation Award 2015 for major social relevance
Vorsters A et al. Eur J Clin Microbiol Infect Dis. 2012:31(5):627-40. by the Government Agency for Innovation by Science
Vorsters A et al. BMJ. 2014: 349:g6252. and Technology
Vorsters A et al. Internat. J of Molecular Sciences. 2016:17,750. Henry Van de Velde Award: Healthcare Award 2017
Vorsters A et al. Eur J Clin Microbiol Infect Dis. 2014:33(11):2005-14.
Arbyn M et al. Journal of Clinical Virology. 2018:107:52-56.
Van Keer et al. Eur J Clin Microbiol Infect Dis. 2018:37(5):859-869.
Pattyn et al. Journal of Virological Methods. 2019:264:23-30.

www.novosanis.com version 2019-04A-EN Subsidiary of OraSure Technologies Inc.

Colli-Pee ®


Device



INDEX - Accuracy of a newly developed first void urine collection device.


Beyers et al, International Papillomavirus Conference.
Lisbon, 2015


- Accuracy of the volume of first void urine, using a newly developed
collection device.
Beyers et al, Knowledge for Growth conference.
Ghent, 2015



- Evaluation of a non-hazardous urine DNA preservative suitable for
at-home collection.
Van Keer et al, International Papillomavirus Conference.
Lisbon, 2015


- Finite element analysis to design a tube and a cap for transportation
of biological liquids.
Beyers et al, Knowledge for Growth conference.
Ghent, 2018


- Co-creation and human factors engineering to drive the design and
development of a next generation Colli-Pee home-based first-void
TM
urine collection.
Donné et al, International Papillomavirus Conference.
Sydney, 2018



- Human Factors Engineering to drive the design and
development of a next generation Colli-Pee home-based
®
first-void urine collection.
Donné et al. World IUSTI.
Vancouver, 2019


- Usability of the Colli-Pee: a first-void urine self-sampling device.
Provinciael et al, Eurogin.
Lisbon, 2018


- Optimization of HPV DNA detection in urine by improving collection,
storage, and extraction.
Vorsters et al. Eur J Clin Microbiol Infect Dis 2015


- Storage and transport recommendations for first-void urine samples
Mehta et al. 2019 (white paper)

















PUBLICATIONS



Literature














Optimization of HPV DNA detection in urine by improving collection,

storage, and extraction.

Vorsters et al. Eur J Clin Microbiol Infect Dis 2015

https://www.ncbi.nlm.nih.gov/pubmed/24916950

Storage and transport recommendations for first-void urine samples
Arya Mehta, Nette Meers, Danielle Pasmans, Vanessa Vankerckhoven, Ronald Van den Bossche, Koen Beyers
August 2019

INTRODUCTION
Urine, in particular, first-void urine (FVU) - first catch - first 20ml can The packaging must meet the following conditions:
be used to detect human papillomavirus virus (HPV)¹, sexually (a) The packaging must consist of three components:
transmitted infections (STIs)² and prostate cancer biomarkers³ . Ÿ a leak-proof primary receptacle(s),
Novosanis' Colli-Pee ® is an easy-to-use device suited for Ÿ a leak-proof secondary packaging, and
standardized and volumetric collection of this first 20ml of urine. Ÿ an outer packaging of adequate strength for its capacity, mass
and intended use, and with at least one surface having
Alongside urine collection, storage, transport and handling are also minimum dimensions of 100 mm × 100 mm.
critical to gain accurate results. Colli-Pee ® that is prefilled with (b) For liquids, absorbent material in sufficient quantity to absorb
Novosanis' proprietary Urine Conservation Medium (UCM), that is the entire contents mustbe placed between the primary
nonlytic, non-toxic, allows preservation of urine during storage and receptacle(s) and the secondary packaging so that, during
transport. transport, any release or leak of a liquid substance will not reach
the outer packaging and will not compromise the integrity of the
1. STORAGE cushioning material.
Storage conditions suggested for FVU collected with UCM: (c) When multiple fragile primary receptacles are placed in a single
Ÿ Short-term storage at room temperature (21-25°C): FVU with secondary packaging, they must be either individually wrapped or
UCM can be stored at room temperature upto 7 days after separated to prevent contact between them.
sample collection⁴.
Ÿ Mid-term storage at -20°C: FVU with UCM can be frozen at -20°C Note: In determining whether a patient specimen has a minimal
until further processing for 7 to 90 days¹. likelihood that pathogens are present, an element of professional
Ÿ Long-term storage at -80°C: FVU with UCM can be aliquoted into judgment is required to determine if a substance is exempt under
cryovials at -80°C for upto 12 months⁵. this paragraph. That judgment should be based on the known
medical history, symptoms and individual circumstances of the
source, human or animal, and endemic local conditions. Examples
Room Temp -20°C -80°C of specimens which may be transported under this paragraph
FVU with UCM 7 days upto 90 days * include the blood or urine tests to monitor cholesterol levels, blood
FVU without UCM >72 hours - - glucose levels, hormone levels, or prostate specific antigens (PSA);
tests required to monitor organ function such as heart, liver or
FVU UCM in cryovials - - upto 12 months
kidney function for humans or animals with non-infectious
Table 1: Storage recommendations for FVU. Room temperature is between diseases, or therapeutic drug monitoring; tests conducted for
21°C to 25°C insurance or employment purposes and are intended to determine
the presence of drugs or alcohol; pregnancy tests; biopsies to
2. TRANSPORT detect cancer and antibody detection in humans or animals.
Tubes and caps of collection devices are fragile and are subject to For those collecting samples which may not fit the definition
leakage, especially if stored for a long period, transported through above, more stringent requirements for transportation apply.
low pressure such as flight, or alongside liquids with low surface These include the use of a rigid outer container, application of
tension. In addition, the plastic creep can weaken the tube-cap UN2814 (Category A pathogens) or UN3373 (Category B
tension over time, causing spillage⁶.
pathogens) labels and demonstration of compliance with pressure
tests.
Colli-Pee 's dispose and unique internal thread concept with inlying
®
closure ring allows prefilled tubes with UCM to be stored and References:
shipped without leakage for 12 months⁶. (1) Vorsters A, Van den Bergh J, Micalessi I, Biesmans S, Bogers J, Hens A, De Coster I,
®
FVU urine collected in Colli-Pee collector tubes prefilled with UCM: Ieven M, Van Damme P. Optimization of HPV DNA detection in urine by improving
collection, storage, and extraction. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):2005-
Ÿ Can be transported by postal mail at ambient temperature⁷. 14. doi: 10.1007/s10096-014-2147-2. Epub 2014 Jun 12. PubMed PMID: 24916950.
Ÿ Can be shipped on dry ice⁸.* (2) Shih SL, Graseck AS, Secura GM, Peipert JF. Screening for sexually transmitted
infections at home or in the clinic?. Curr Opin Infect Dis. 2011 Feb;24(1):78-84. doi:
10.1097/QCO.0b013e32834204a8. Review. PubMed PMID: 21124216; PubMed Central
Shipping guidelines for exempt specimen samples: PMCID: PMC3125396.
Air transportation of diagnostic specimens is governed under (3) Fujita K, Nonomura N. Urinary biomarkers of prostate cancer. Int J Urol. 2018
authority of the International Civil Aviation Organization (ICAO) and Sep;25(9):770-779. doi: 10.1111/iju.13734. Epub 2018 Aug 21. Review. PubMed PMID:
30129068.
its regulations are published by the International Air Transport (4) Data on file - Clinical evaluation of a urine preservative for HPV detection in first-void
Association (IATA). Since courier services designated as “ground” urine.
may involve an air transport segment, the IATA publications are (5) Van Keer S, Tjalma WAA, Pattyn J, Biesmans S, Pieters Z, Van Ostade X, Ieven M, Van
Damme P, Vorsters A. Human papillomavirus genotype and viral load agreement
broadly applicable to both air and ground shipment. between paired first-void urine and clinician-collected cervical samples. Eur J Clin
Microbiol Infect Dis. 2018 May;37(5):859-869. doi: 10.1007/s10096-017-3179-1. Epub
The IATA Dangerous Goods Manual was revised on January 1, 2005, 2018 Feb 7. PubMed PMID: 29417310; PubMed Central PMCID: PMC5916996.
(6) Beyers K, Van Mulder T, Provinciael T, Meers N, Cortes A, Gernaey M, Sorgeloos K,
and most recently amended accordingto Addendum III, issued on Vankerckhoven V. Finite element analysis to design a tube and cap for transportation of
July 5, 2005. This addendum introduces the following guidance: biological liquids. Poster presented at Knowledge for Growth (KfG2018). Poster 53
(7) Pattyn J, Van Keer S, Biesmans S, Ieven M, Vanderborght C, Beyers K, Vankerckhoven
V, Bruyndonckx R, Van Damme P, Vorsters A. Human papillomavirus detection in urine:
3.6.2.2.3.6 Patient specimens for which there is minimal likelihood Effect of a first-void urine collection device and timing of collection. J Virol Methods. 2019
that pathogens are present are not subject to these regulations if the Feb;264:23-30. doi: 10.1016/j.jviromet.2018.11.008. Epub 2018 Nov 16. PubMed PMID:
specimen is transported in a packaging which will prevent any 30452931.
(8) Franceschi S, Chantal Umulisa M, Tshomo U, Gheit T, Baussano I, Tenet V, Tshokey T,
leakage and which is marked with the words “EXEMPT HUMAN Gatera M, Ngabo F, Van Damme P, Snijders PJ, Tommasino M, Vorsters A, Clifford GM.
SPECIMEN”or “EXEMPT ANIMAL SPECIMEN”, as appropriate. Urine testing to monitor the impact of HPV vaccination in Bhutan and Rwanda. Int J
Cancer. 2016 Aug 1;139(3):518-26. doi: 10.1002/ijc.30092. Epub 2016 Apr 15. PubMed
PMID: 26991686.
*Colli-Pee collector tubes may become brittle upon storage at -80°C hence should be handled with care.
®

novosanis www.novosanis.com version 2019-08A Subsidiary of OraSure Technologies, Inc.



HPV


Brochure



GAME-CHANGING

SAMPLING DEVICES








TOWARDS A WORLD WITHOUT CERVICAL CANCER


Cervical cancer remains a global challenge, leading to 275,000
deaths annually, worldwide.
“Cervical cancer is still
the 4th most common cancer in As nearly all cervical cancers are caused by a persistent cervical infection with a high risk
women despite proven efficacy human Papillomavirus, vaccination and primary HPV screening have the potential to
reduce the burden of cervical cancer.
of screening programs” 1 Public screening programs must achieve high compliance to be effective and efficient, yet
participation is low in many countries despite standard invitations and recall systems.
Reasons mentioned for non-attendance are the relative invasive character of cervical
sampling, ethnicity and culture, lack of time and the need to visit a clinician.
Importantly, especially young women are often reluctant to have a PAP smear.



NON-ATTENDEES
ACROSS EUROPE



40%





50 MILLION WOMEN TO BE SCREENED VACCINATION, AN EFFECTIVE METHOD HPV TESTING
20 MILLION NOT PARTICIPATING TO PREVENT CERVICAL CANCER IN FIRST-VOID URINE

Colli-Pee ®










COLLI-PEE ® An innovative approach to test high risk HPV and biomarkers in the same sample 2


The mucus and debris from exfoliated superficial Volumetric and standardized first-void urine collection
cell layers of a cervix carcinoma are washed Allows hygienic and non-invasive self-sampling (at home)
away by the first urine that passes. 3 No need to interrupt the urine flow
This first-void urine combined with a preservative
to prevent HPV DNA breakdown by DNA Collector tube prefillable with preservative
nucleases contains a significantly higher number Not interfering with the natural history of the infection 4
of HPV DNA copies. 3 Useful for post-vaccination HPV surveillance
5















1. Uncap 2. Assemble 3. Collect first-void urine 4. Disassemble 5. Recap

COLLI-PEE ® Enabling higher analytical sensitivity for HPV DNA detection in urine




Studies performed by A. Vorsters et al, in which participants with a self-reported HPV infection provided first-void urine samples,
confirm that when an appropriate preservative and DNA extraction method is used, urine is a reliable and reproducible sample for HPV
®
DNA testing. Samples collected by the Colli-Pee device yielded a significantly higher number of copies of hDNA and HPV DNA
compared to regular urine collector devices, independent whether the first-void is taken from the first urine of the day or from urine
6 , 7
provided later in the day.

Copies HPV16 Copies HPV16
10.000.000 10.000.000

1.000.000 1.000.000

100.000 100.000

10.000 10.000

1.000 1.000

100 100
1 5 10 25 1 5 10 25
A ernoon Participant ID Colli-pee Participant ID
First morning Urine cup
Average copies of HPV DNA per participant and Average copies of HPV DNA per participant and
per HPV genotype found in first morning FV and per HPV genotype found in Colli-Pee and urine
®
afternoon FV urine. cup collected first void urine.

Colli-Pee collected samples show higher HPV concentration than cup collected samples. 7
®


Proof of concept studies with commercially available diagnostic assays for automated screening (Roche Cobas HPV, BD Onclarity
™
®
HPV, Aptima HPV Hologic Panther), point of care testing (Cepheid Xpert HPV) or genotyping (Genefirst Papilloplex HR-HPV, Anyplex
™
®
™
®
™
II HPV HR Seegene, Fujirebio Innolipa , High+Low Papillomastrip Operon) confirm HPV DNA detection in first-void urine is feasible. 8 to 15
1. Stewart, B et all World Cancer Report 2014 10. Vorsters et al. Eurogin 2016, Salzburg, AT, Poster #12-17
2. Van Keer et all Eur J Obstet Gynecol Reprod Biol., 2017, 216, 1-11 11. Vorsters et al. Eurogin 2016, Salzburg, AT, Poster #12-21
3. Vorsters et al. Eur J Clin Microbiol Inf Dis, 2014, 33 (11) 2005-2014 12. Vorsters et al HPV2017, Capetown, SA, poster #HPV17-0542
4. Vorsters et al. Human Vaccines and Immunotherapeutics, 2015;11(2):350–2. 13. Van Keer et al HPV2017, Capetown, SA, poster #HPV17-0667
5. Pathak N et all BMJ. 2014;349 g5264. 14. Vorsters et al. EUROGIN 2017, Amsterdam, NL, Poster
6. Vorsters et al. 30th IPV Conference, 2015, Lisbon, PT, Poster #421 15. Vorsters et al. EUROGIN 2018, Lisbon, PT, Poster
7. Pattyn et al. Journal of Virological Methods, 2019, 264, 23-30. 16. Wentzen et al. Preventive Medicine, 2017, 98, 33-35
8. Vorsters et al. 30th IPV Conference, 2015, Lisbon, PT, Poster #422 17. Leeman A. et al. BJOG. 2017;124(9):1356-1363
9. Vorsters et al. Eurogin 2016, Salzburg, AT, Poster #12-16 18. Franceschi et al, Vaccine, 2018, 36, 4816-4822

COLLI-PEE ® Empowering higher cervical cancer screening participation



Self-sampling can increase the screening coverage and
reduce cervical cancer rates in populations that would
16
otherwise not be screened.
PTS
Physician Taken Sample
The EVAH study showed that physician-taken smears,
brush-based self-sampling and first-void urine are equally
sensitive to detect CIN2+ using two different hrHPV tests
(the highly sensitive SPF10 LiPA 25, version 1 assay or the
clinically validated GP5+/6+ based luminex assay). None
of the samples or assays missed CIN3. 17 SS
Self Sample
Colli-Pee was equally sensitive in detection
®
of CIN2+ as physician-taken smears
FVU
First-void urine


Sensitivity and specificity of hrHPV testing for CIN2+ detection in physician taken smear (PTS), self-sample (SS),
morning first-void urine (FVU1) and first-void urine from later during the day (FVU2) tested with SPF10 and GP5+/6+
SPF10 GP5+/6+

Sample Sensitivity Specificity Sensitivity Specificity
% 95% CI % 95% CI % 95% CI % 95% CI

PTS 100 83-100 33 24-45 95 75-99 39 28-50

SS 100 83-100 35 25-46 95 75-99 43 32-55
FVU1 95 75-99 32 22-43 95 75-99 42 31-53

FVU2 100 83-100 29 20-41 95 75-99 42 31-53






“Self-collected urine, through a first-void urine collection device, has the potential to increase uptake of
cervical cancer screening. Urine collection can be more comfortable and more socially acceptable for some
women who are reluctant to perform a vaginal examination”
Professor Clementina Cocuzza,
of the Department of Medicine and Surgery, University of Milan-Bicocca, Italy

First-void urine is a feasible sample type
to monitor the impact of HPV vaccina on
programs³.



COLLI-PEE Urine testing allows to monitor the impact of HPV vaccination
®

A vaccine impact study conducted by the World Health Organization (WHO) and International Agency for Research on
Cancer (IARC) in Bhutan and Rwanda demonstrated first-void urine is a very well-accepted liquid biopsy source that can
be easily and non-invasively collected with minimal requirements for trained staff. 18



“I am convinced that the clinical and diagnostic information present in a first-void urine sample still is greatly
underestimated. We confirmed that first-void urine is an interesting sample to monitor HPV vaccination
programs; possibilities in cervical cancer screening programs are being explored. The non-invasive character of
urine sampling, with option of home collection, will definitely help to enroll underserved women in cervical
cancer screening and follow-up programs across the world.”
Alex Vorsters
PhD and Project Group Leader HPV VAXINFECTIO (University of Antwerp)








STANDARDIZED VOLUMETRIC USER
FIRST-VOID SELF-SAMPLING FRIENDLY

COLLI-PEE ® For customized standardized first-void urine collection
As a trusted partner of diagnostic companies, Novosanis develops ®
®
customized versions of Colli-Pee for improved diagnostic accuracy Colli-Pee
and patient comfort. Bespoke tube design allows high-throughput
processing, centrifugation and workflow optimization.
Successful automation
starts with sampling
























Colli-Pee ®










UCM-Preservative




UCM-Preservative For improved preservation of urine sample
®
The collection tube of the Colli-Pee device contains a UCM (Urine
Conservation Medium) buffer for a general preservation of the
urine during storage and transport. This will allow for storage at
ambient temperature for up to 7 days. The combination with the
UCM preservative is CE-marked.





www.novosanis.com Version 2019-06A-EN Subsidiary of OraSure Technologies Inc.

Comparison of first-void urine using

the Colli-Pee device and a regular
®

urine cup, for HPV testing.



INDEX - Performance of a new first-void urine collection device.

Vorsters et al, International Papillomavirus Conference.
Seattle, 2014


- HPV DNA detection in urine: Effect of a first-void urine collection
device and time of collection.
Vorsters et al, International Papillomavirus Conference
Lisbon, 2015


- HPV DNA detection in urine: effect of a first-void urine collection
device and timing of collection.
Pattyn et al, International Papillomavirus Conference
Cape Town, 2017



- Human papillomavirus detection in urine: Effect of a fist-void urine
collection device and timing of collection.
Pattyn et al, Journal of Virological Methods 2019







PUBLICATIONS



Literature














Human papillomavirus detection in urine:

Effect of a fist-void urine collection device and timing of collection

Pattyn et al, Journal of Virological Methods 2019

https://www.ncbi.nlm.nih.gov/pubmed/30452931



First-void urine as an alternative

to clinical collected samples for


HPV testing.



INDEX - First-void urine and physician-taken smear show similar sensitivity

for the detection of CIN2+ lesions.
Leeman et al, ECCMID.
Amsterdam, 2016


- The detection of hrHPV-infection of the cervix using first-void urine

in women with an abnormal pap-smear.
Leeman et al, International Papillomavirus Conference.
Lisbon, 2015


- First-void urine: a potential biomarker source for cervical HPV
infection and disease.
Van Keer et al


- Urine Testing for HPV: Rationale for using first void.
Vorsters et al., BMJ 2014


- HPV testing in first-void urine provides sensitivity for CIN2+
detection comparable to a physician-taken smear or brush-based
self-sample: cross-sectional data from a triage population.
Leeman et al, International Journal of Obstetrics and
Gynecology 2017


- VALHUDES: A protocol for validation of human papillomavirus

assays and collection devices for HPV testing on self-samples
and urine samples.
Arbyn et al, Journal of Clinical Virology 2018


- Human papillomavirus genotype and viral load agreement between
paired first-void urine and clinician-collected cervical samples.
Van Keer et al, Eur J Clin Microbiol Infect Dis 2018


- Long-Term Follow-up of HPV Infection Using Urine and Cervical
Quantitative HPV DNA Testing .
Vorsters et al, International Journal of Molecular Sciences, 2016


- First-void urine: A potential biomarker source for triage of high-risk
human papillomavirus infected women.
Van Keer et al, Eur J Obstet Gynecol Reprod Biol., 2017









PUBLICATIONS



Literature











Urine Testing for HPV: Rationale for using first void
Vorsters et al., BMJ 2014

https://www.ncbi.nlm.nih.gov/pubmed/25319476


HPV testing in first-void urine provides sensitivity for CIN2+ detection comparable

to a physician-taken smear or brush-based self-sample: cross-sectional data from
a triage population

Leeman et al, International Journal of Obstetrics and Gynecology 2017
https://www.ncbi.nlm.nih.gov/pubmed/28391609



VALHUDES: A protocol for validation of human papillomavirus assays and

collection devices for HPV testing on self-samples and urine samples
Arbyn et al, Journal of Clinical Virology 2018
https://www.ncbi.nlm.nih.gov/pubmed/30195193




Human papillomavirus genotype and viral load agreement between paired first-
void urine and clinician-collected cervical samples
Van Keer et al, Eur J Clin Microbiol Infect Dis 2018

https://www.ncbi.nlm.nih.gov/pubmed/29417310



Long-Term Follow-up of HPV Infection Using Urine and Cervical Quantitative HPV
DNA Testing

Vorsters et al, International Journal of Molecular Sciences, 2016
https://www.ncbi.nlm.nih.gov/pubmed/27196899



First-void urine: A potential biomarker source for triage of high-risk human
papillomavirus infected women.

Van Keer et al, Eur J Obstet Gynecol Reprod Biol., 2017

https://www.ncbi.nlm.nih.gov/pubmed/29417310

Use of first-void urine on

commercially available


HPV assays.

INDEX - Performance of an Automated HPV Genotyping Assay using First

Void Urine Specimens
Vorsters et al, International Papillomavirus Conference
Lisbon 2015


- Comparison of HPV positivity and viral load in self-collected vaginal

samples and urine using four collection devices (Predictors5.1 study)
J. Cuzick et al, ASCCP
Atlanta 2019


™
®
- Evaluation of the Roche COBAS HPV assay with Colli-Pee
collected, UCM preserved Urine.
Vorsters et al , Eurogin
Sevilla, 2016


- Evaluation of the Roche COBAS 6800 HPV assay with Colli-Pee
™
®
collected, UCM preserved Urine.
Vorsters et al, Eurogin
Amsterdam, 2017


- Detection of HPV in first-void urine using an E6/E7 HPV mRNA
assay in women referred for colposcopy
Van Keer et al, International Papillomavirus Conference
Cape Town, 2017


- Pilot feasibility study on use of Cepheid Xpert HPVwith Colli-Pee
®
™
collected UCM preserved urine.
Vorsters et al , Eurogin
Salzburg, 2016

™
- Compatibility of Genefirst Papilloplex HR-HPV genotyping assay for
testing first void urine specimens.
Vorsters et al , Eurogin
Salzburg, 2016


- Compatibility of a single closed tube real-time PCR assay for testing
first void urine specimens.

Vorsters et al, International Papillomavirus Conference
Cape Town, 2017


- Pilot study on the use of INNO -LiPA HPV Genotyping Extra II with
®
™
Colli-Pee collected UCM preserved urine
Pattyn et al,
Eurogin Amsterdam, 2017


®
- Evaluation of the INNO-LiPA HPV genotyping extra II on UCM
preserved first-void urine.
Vanlerberghe et al, Eurogin
Lisbon, 2018


- Preliminary evaluation of the High+Low Papilloma Strip assay with
®
Colli-Pee collected UCM preserved urine.
Vorsters et al, Eurogin
Lisbon, 2018