Bladder Cancer Liquid Biopsy Test
Dr. Lee Kian Chung (PhD)
October 12, 2020
SLIDE 1

BioCheetah’s Startup Journey2012 - 2015❑

Discovery of novel
bladdercancerbiomarkers
inProfessor
Thiery’s
A*STAR lab:
opublication in 2015 by
BioCheetah’s ScientificFounder, Prof Jean Paul
Thiery in Oncotarget
Journal2016 - 2017
❑Gap funding
A*STAR:oo2018 - 2019by❑revalidationofOncotarget publication
toensuredata
reproducibility
preclinicalvalidation
using 132 new clinicalsamples

Formation of spinoff
company
BioCheetah Pte Ltd:ooo

Reference: Kumar et al., 2015Oncotarget 6 (15):13539 - 49

SLIDE 2company incorporated
in 2018
buildingofpilot
manufacturing site inSingapore
bladdercancerbiomarker
patents
granted in Singapore,Japan, Europe, China &USA

2020 - 2021
❑Product development& clinical trial:oooo

development of ELISA kit& POCT test kit
ISO13485
certification
application
clinical trials on-going in
Singapore,
China&France
planned R&D expansion
in Guangzhou, China

Scenarios❑Usual start in the dayonormal❑ Unusual start in the dayo blood in the urine

cause for worry /anxiety❑ Possible causes of hematuria:urinary tract infections (UTI)
polycystic kidney disease, chronic kidney disease
nephrolithiasis stones formed in kidneys, urinary bladder &ureters
4. glomerulonephritis (acute inflammation of kidney)
5. trauma
6. strenuous exercise & vigorous workout
7. kidney cancer or prostate cancer or bladder cancer
1.
2.
3.

SLIDE 3

Diagnosis for Hematuria Causes❑ Physical examination to check for injuries❑ Urine tests for urinary tract infection❑ Imaging tests eg. CT scan, MRI, ultrasound❑ Cystoscopy is the standard of care for hematuria (invasive test, requires anesthesia & longwaiting period)

SLIDE 4

Current Management of Bladder Cancer Cases❑ Waiting period for a investigative cystoscopy: 4-5 weeks❑ Bottleneck is due to:(1) limited number of urologists to perform the cystoscopy procedure(2) number of procedures that can be performed in a day due tolimited number of procedure rooms

SLIDE 5

Bladder Cancer Diagnostics: Market Potential❑❑❑

Bladder cancer is the 10th most common cancer in the world, 6th formen
There are about 2.7million bladder cancer patients globally
About 549,000 new cases & 200,000 deaths per year (GLOBOCAN
2018)1o❑Hematuria (blood in urine) is the most common sign of bladdercancer3:oooo❑

estimated 150,000 newly diagnosed in Asia and 80,500 in China (Chen et al.,2016)2

85% of bladder cancer patients have hematuria
macrohematuria : 10 - 20% confirmed bladder cancer
microhematuria: 1 - 5% confirmed bladder cancer
confirmed diagnosis of bladder cancer by cystoscopy

Continuous patient surveillance after treatment – need a simple,
repeat use and non-expensive solution:oo

70% recurrence after treatment
50% progression to late stages

SLIDE 6

Global Bladder Cancer Incidence on The
RiseIncidence 2018

Australia

Incidence 2012

JapanUSChinaEuropeThousands

050100150200Comparison between Globocan 2012 and 2018
data on bladder cancer incidence in the world
showing an increase of 27.7% new bladdercancer cases

Ongoing monitoring needs
References:
1) Globocan 2018
2) Chen et al., CA Cancer J Clin 2016; 66: 115-132
3) Shirodkar & Lokeshwar, Expert Rev Anticancer Ther. 2008 July; 8(7): 1111–1123
4) Diagnosis of bladder cancer with 3,500 cystoscopy in Singapore General Hospital (June 2016 - May 2017)

Bladder Cancer Incidence in Japan❑ Bladder cancer is the 5th most common cancer among males (Globocan 2018)
oage-standardized incidence rates for males in bladder cancer is high in Hiroshima & moderately
high in Osaka

Number of new cancer cases in Japan in 2018; males, all ages
was 504,648
References:
1) Globocan 20182) Matsuda & Niino, Jpn J Clin Oncol 2018; 48: 953 - 954

SLIDE 7Age-standardized incidence rates for males in bladdercancer (per 100,000)

BioCheetah’s Solution: Urine Biopsy

Speed- Rapid, non-invasive bladder cancer test

Precision - Offers accurate detection of bladder cancer
Health- Allows higher effective patient triage

Targeted For - Hematuria & High-risk Individuals
SLIDE 8

How It Works: 5 Urinary Biomarkers Present
Exclusively in Bladder Cancer
Healthy

early stage
bladdercancerlate stage
bladdercancerlung
cancerprostate
cancerbreastcancerdiabetes

benignprostatic
hyperplasia

Biomarker

#1
#2
#3
#4
#5

*n = 451 patients with different stages of bladder cancer, other cancer types and other non-cancer chronic diseases❑❑❑❑

High diagnostic performance based on Area under Receiver Operating Characteristic
curve (AUROC): 0.981
High accuracy: 92.1%
Extremely high sensitivity: 99.0%
High Negative Predictive Value: 96.3%
SLIDE 9

Competitors Landscape showing BioCheetah’s Superior
Diagnostic Performance among Competing Products: Preclinical data
Diagnostic
Performance

Company A

Sens / spec% (all stages) •❑❑Ta/T1 low risk
T2/T3 high risk

Company BCompany C• 81.8% / 85.1%•98.7% / 83.9%• not available• not available• not available• not available• not available• 100.0%/ 83.9%• not available• not available• not available• not available• not available

•

96.3%

•

97.0%

•

95.2%

•

not available•

10 minutes•

2 days•64% / 75%•

Urinecytology

99.0% / 83.9%

58% / 88%•

Company D

63% / 87%•

37% / 95%

Predictive value (all)❑❑Negative
Positive

Turn around time❑❑

POC
LDT / IVD

Clinical use
Cost per test (US$)

not available

not available

•

94.1%

•

not available

not available• not available• 30 minutes• 5 minutes• not available• not available• 5 days• not available• not available• 4-12 days

• 3 days

Diagnosis &Monitor

Diagnosis &Monitor

Diagnostic only

Diagnostic only

Diagnostic only

Diagnosis &Monitor

To be determined$$$$$$$$$$SLIDE 10

Products: Non-invasive Bladder Cancer detection in Hematuria& Bladder Cancer Patients
Phase 1: ELISA Kit (LDT/RUO & IVD)

urine

ELISA kitPhase 2: Rapid Point-of-Care Test (POCT)ELISA test

urine

POCT
PRODUCTPRODUCT

Performance
Indication

Performance
Indication

Current results

Accuracy

92.1%

Sensitivity

99.0%

Specificity

83.9%

POCT Reader

ELISA
plate reader

Singapore
TargetCustomers:

POCT(under-development)

Accuracy

Target above 90%

Sensitivity

At least 3 out of 5 test bands

Specificity

At least 3 out of 5 test bands

Singapore
TargetCustomers:
GPs

SLIDE 11

Bladder Cancer All Stages versus Healthy❑ Discriminating bladder cancer patients from non-bladder cancer patients:

Risk Score on &above cut-off

Risk Score
below cut-off

Scatter dot plot of risk score obtained from Ensemble K-fold crossvalidation model comparing healthy (n = 31) and bladder cancer
all stages patients (n = 101). Colored bars indicate median andinterquartile range.

SLIDE 12❑

Other tests to check for cause ofhematuria or urological issues eg.
CT scan, MRI, ultrasound, urine
cultureBioCheetah’s Vision for the Future❑ To be a leader in urinalysis for urological cancers:

urine

Bladder
Cancer Test

KidneyCancer Test

Prostate
Cancer Test

- ve test- ve test- ve test

otherinvestigativetests+ ve test+ ve test+ ve test
otherinvestigativetests

otherinvestigative
tests

Rx

Rx

SLIDE 13Rx

THANK YOU
www.biocheetah.com❑oCorporate Office & Manufacturing Facility

79 Ayer Rajah Crescent, LaunchPad @ One-North, #05-09, Singapore 139955❑oR&D Laboratory

61 Biopolis Drive, #6-04B Proteos, Singapore 138673
SLIDE 14