Novosanis Sampling Solutions

Follow-up of HPV

vaccination using


first-void urine



INDEX - Assessment of acceptability of first-void urine sampling for HPV

DNA detection in young women.
Van Keer et al,
Eurogin Sevilla, 2016

- The use of urine in HPV vaccination follow-up trials.
Vorsters et al, Human Vaccines & Immunotherapy 2015


- Urine testing to monitor the impact of HPV vaccination in Bhutan
and Rwanda Franceschi et al, International Journal of Cancer 2016


- Evaluation of the performance of Human Papillomavirus testing in
paired urine and clinician-collected cervical samples among women
aged over 30 years in Bhutan Tshomo et al, Virology Journal 2017


- First-void urine as a non-invasive liquid biopsy source to detect
vaccine-induced human papillomavirus antibodies originating
from cervicovaginal secretions Van Keer et al, Journal of Clinical
Virology 2019





PUBLICATIONS



Literature












The use of urine in HPV vaccination follow-up trials
Vorsters et al, Human Vaccines & Immunotherapy 2015

https://www.ncbi.nlm.nih.gov/pubmed/25664398



Urine testing to monitor the impact of HPV vaccination in Bhutan
and Rwanda

Franceschi et al, International Journal of Cancer 2016

https://www.ncbi.nlm.nih.gov/pubmed/26991686



Evaluation of the performance of Human Papillomavirus testing
in paired urine and clinician-collected cervical samples among women

aged over 30 years in Bhutan
Tshomo et al, Virology Journal 2017

https://www.ncbi.nlm.nih.gov/pubmed/28390433



First-void urine as a non-invasive liquid biopsy source to detect

vaccine-induced human papillomavirus antibodies originating from
cervicovaginal secretions

Van Keer et al, Journal of Clinical Virology 2019
https://www.ncbi.nlm.nih.gov/pubmed/31129514

STI’s


Brochure



GAME-CHANGING

SAMPLING DEVICES










TOWARDS A WORLD WITHOUT SEXUALLY TRANSMITTED INFECTIONS

Sexually transmitted infections (STI’s) continue to be an important cause of morbidity and
[“357 million new cases of mortality worldwide. Screening can reduce the burden. But many populations face barriers to

curable sexually transmitted screening: lack of services and transport, stigma, confidentiality concerns, cost and lack of
infections occurred in 2012 knowledge and awareness about STI’s.¹
(WHO estimates)”] Improvements in screening rates for sexually transmitted infections can be achieved with
home-based screening methods using self-collected samples such as first-void urine.
As the concentration of Chlamydia sharply decreases during urination, it is important to use
the first fraction of micturition. ²














70% OF COUNTRIES HAVE STI 357 MILLION NEW SUITED FOR ONLINE
SURVEILLANCE SYSTEMS IN PLACE INFECTIONS EVERY YEAR STI SAMPLING

Colli-Pee ®









COLLI-PEE ® An innovative approach to improve the quality of STI testing



“Thanks to the availability of sensitive molecular Volumetric and standardized first-void urine collection
diagnostic tests and self-sampling devices for non- Allows hygienic and non-invasive self-sampling (at home)
invasive samples like urine, it’s feasible to conduct No need to interrupt the urine flow
STI screening in non-clinical settings increasing the
participation rate of difficult to reach high-risk Collector tube prefillable with preservative
populations .”


[”A recent review reported that home-based STI screening resulted in up
to 11 times higher testing rates compared to the clinic-based screening” ³]














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

COLLI-PEE ® Outperforms routine urine collection for the detection of STI's




The use of the Colli-Pee collection device in a CT Routine urine sample
®
Belgian HIV prevention study among Men who Colli-Pee ® Positive Negative Total
have Sex with Men (MSM) resulted in the Positive 6 3 9
additional detection of 11 STI's (3 more Negative 1 454* 455
Chlamydia trachomatis (CT), 2 more Neisseria Total 7 457 464
gonorrhoeae (NG) and 6 more Mycoplasma *Two results were not-confirmed in the clinic-based sample
genitalium (MG)) compared to the use of the MG Routine urine sample
regular urine cup. Only 3 infections (1 low positive Colli-Pee ® Positive Negative Total
CT and 2 MG) were missed. Positive 25 6 31
Negative 2 431 433
Total 27 437 464


®
Colli-Pee was highly valued by the participants NG Routine urine sample
of the HIV prevention study, conducted at the Colli-Pee ® Positive Negative Total
Institute of Tropical Medicine in Antwerp.⁴ Positive 7 2 9
Negative 0 455 455
Total 7 457 464
88% 90%
found it easy found it easy
to very easy to ship via TV Routine urine sample
to use postal mail ®
Colli-Pee Positive Negative Total
Positive 0 0 0
[Colli-Pee is more convenient for first-void urine Negative 0 464 464
®
collection at home and allows to detect more STI’s.] Total 0 464 464












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 ®
and patient comfort. Bespoke tube design allows high-throughput Colli-Pee
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.


1. Hengel B et al. BMC Public Health 2013 13:1040.
2. Meyer T. Microorganisms 2016;4(3):E25
3. Shih SL et al: Curr Opin Infect Dis. 2011; 24(1): 78–84
4. De Baetselier I et al: BMJ Open 2019: 9:e028145

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

First-void urine collected

samples for detection of


STIs and Zika virus.



INDEX - COLLI-PEE: A new device to collect first-void urine at home for

molecular detection of STIs
De Baetselier et al, World IUSTI
San Paolo, 2017

- Evaluation of the ‘Colli-Pee’, a fist-void urine collection device for
self-sampling at home for the detection of sexually transmitted
infections, versus a routine clinic-based urine collection in a one-to-
one comparison study design: efficacy and acceptability among
MSM in Belgium
De Baetselier et al, BMJ Open 2019


- Urine collected through Colli-Pee® offers potential for self-sampling
at home for detectionof sexually transmitted infections
Mehta et al. 2019 (white paper)


- A comparison of serum and urine samples for the detection of Zika

virus RNA in a high prevalence population using a real-time PCR
based assay Zambrano et al,
ASM , 2018





PUBLICATIONS



Literature












Evaluation of the ‘Colli-Pee’, a fist-void urine collection device for

self-sampling at home for the detection of sexually transmitted

infections, versus a routine clinic-based urine collection in a one-

toone comparison study design: efficacy and acceptability among

MSM in Belgium

De Baetselier et al, BMJ Open 2019













Biomarkers


Brochure



GAME-CHANGING

SAMPLING DEVICES









TOWARDS A WORLD WITHOUT CANCER

“The predicted global cancer Early detection of cancer greatly increases the chances for successful treatment,
burden is expected to exceed improving the overall survival and quality of life of patients.
20 million new cancer cases Biomarkers, biological molecules such as proteins or nucleic acids, play a critical role
compared
annually by 2025, in the course of the disease. They can be found in tissues and bodily fluids such as
with the estimated 14.1 million urine and can be used to detect cancer in an early stage and to follow up disease
progression. Easy detectable biomarkers improve early diagnosis and cancer
new cases worldwide in 2012. outcome.
(WHO estimates)” As urine is an easily accessible and non-invasive sample, the use of urinary
biomarkers to detect, monitor and follow up treatment of urological but also systemic
cancers is attractive.








41%





BIOMARKER TESTING IN URINE HAS LIQUID BIOPSIES DON’T URINARY BIOMARKER TESTING CAN AVOID
POTENTIAL TO TRANSFORM CANCER CARE NEED SURGICAL INTERVENTION UP TO 41% OF PROSTATE BIOPSIES¹

Colli-Pee ®










COLLI-PEE ® An innovative solution to standardize urinary biomarker testing


Reproducible urine testing requires appropriate Volumetric and standardized collection of first-void urine
collection methods and storage conditions. For containing a higher amount of DNA than subsequent
4
analytes such as nucleic acids it is critical to use a fractions
proper preservative upon collection. 2 Allows hygienic and non-invasive self-sampling (at home)
Increases patient comfort for men and women
Collector tube prefillable with preservative
[”Well standardized procedures for collection, transport, Correct sample-to-buffer ratio
sample preparation and analysis should become the Immediate mixing
basis of an effective diagnostic strategy for urinalysis” ³] Avoids biomarker degradation















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

COLLI-PEE ® Urine, a promising liquid biopsy sample type for biomarker testing



When tissue is an issue
Biopsies are essential tools to achieve the objectives of
precision oncology. Unfortunately obtaining tissue is not
always feasible.
Liquid biopsies, including urine, have the potential to address
the difficulties of (repeated) sampling and the limitations of PROSTATE BLADDER OVARIES/
tumor heterogeneity. CERVICAL







KIDNEYS LUNGS LARGE
INTESTINE




Cancer cells growing through normal tissue


Can yellow be the new red? BREAST PANCREAS
Urine testing is non-invasive, allowing cost-efficient fast and
serial sampling for real-time monitoring of cancer progression
and therapeutic effect.
Unless visibly contaminated with blood, urine does not carry [”Urine sampling adds depth and convenience:
any risk of bloodborne pathogens (HIV, HBV, HCV) urine cell-free tumor DNA exceeds plasma sensitivity
transmission.⁵ in studies of renal, bladder and prostate cancer,
Due to the low protein content of urine, isolation of DNA from but surprisingly also in some series of lung and colon
urine is technically easier than from serum or plasma.⁶ cancers” ⁷]








NON-INVASIVE STANDARDIZED USER
LIQUID BIOPSY 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 ®
and patient comfort. Bespoke tube design allows high-throughput Colli-Pee
processing, centrifugation and workflow optimization.
Successful automation
starts with sampling






















Colli-Pee ®










UCM-Preservative





UCM-Preservative For improved stability of biomarkers in 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
1. Siebren Dijkstra et al. 2017, NPV data on page 663 preservative is CE-marked.
2. Lin SY et al. 2017
3. Delanghe et al. 2013
4. Vorsters et al. 2014
5. CDC “The National Healthcare Safety Network (NHSN) Manual”, 2013, USA
6. Ying-Hsiu Su et al. 2004
7. Krishnamurthy et al. 2017
www.novosanis.com Version 2019-05A-EN Subsidiary of OraSure Technologies Inc.

Proofsource


Biomarkers







Prostate Cancer


Brochure



GAME-CHANGING

SAMPLING DEVICES










TOWARDS A WORLD WITHOUT PROSTATE CANCER

“Prostate cancer is the most To successfully cure patients with prostate cancer it is important to detect the

frequently diagnosed cancer disease at an early stage.
and the second leading Current screening techniques are based on a measurement of serum prostate
cause of death among men specific antigen (PSA) levels and a digital rectal examination (DRE). Drawbacks
in Western countries.“ of PSA testing are its low sensitivity and specificity.
Recently, prostate cancer specific markers for the early detection of disease and
the prediction of aggressiveness of a prostate tumor have become available.















1.1 MILLION MEN DIAGNOSED 307,000 MEN DIED FROM EARLY DETECTION OF PROSTATE
WITH PROSTATE CANCER IN 2012 PROSTATE CANCER IN 2012 CANCER IN FIRST-VOID URINE

Colli-Pee ®









COLLI-PEE ® A user-friendly first-void urine collection device suitable for self-sampling


Because of the ease of collection and the fact that Volumetric and standardized first-void urine collection
prostate cells are directly released into the urethra
through prostatic ducts after DRE or prostate
massage, urine has become the future of non-invasive Allows hygienic and non-invasive self-sampling (at home)
biomarker testing.¹
No need to interrupt the urine flow
In 2008, Theodorescu et al. found that mid-stream
urine was uninformative, but first-void urine was able
to identify patients with prostate cancer with 91% Collector tube prefillable with preservative
sensitivity and 69% specificity. ²














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

COLLI-PEE ® An innovative approach to non-invasive prostate cancer testing







Several DNA, RNA, proteins and metabolite-based
prostate cancer biomarkers for early diagnosis and
follow-up of prostate cancer tumors have been
identified.

Many studies have shown the feasibility of urine for
the non-invasive detection of prostate cancer but
the quality of the sample and analytical procedures
utilized are critical components of these assays.

The use of the urinary biomarker-based test
®
SelectMDx decreases the number of unnecessary
biopsies needed and has the potential to reduce
over-treatment of insignificant prostate cancers.
This strategy results in health gain (QALY) and cost
savings. OEM product MDxHealth ®
3


“It is well-timed that our UrNCollect device is
TM
launching as a complement to the SelectMDx IVD PCR
®
kit because pilot studies demonstrated that patients
and physicians found the device easier to use than
traditional urine collection tubes.”
Dr. Jan Groen
®
CEO of MDxHealth







STANDARDIZED COST EFFECTIVE USER
FIRST-VOID APPROACH 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 ®
and patient comfort. Bespoke tube design allows high-throughput Colli-Pee
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.


1. Hessels & Schalken. 2013
2. Theodorescu et al. 2008
3. Govers et al. 2018

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