Page 17
Urine carries genetic material from bladder cancers that can be used as a marker of disease
Urine a vehicle to test for bladder cancer markers Due to its anatomical location and function , urine is an obvious source of markers for bladder cancer . Of patients that present with microscopic / macroscopic haematuria ( blood in urine ), less than 10 % have bladder cancer . Common benign causes of this include renal stones and infections . Similar to prostate cancer , tests screening for nucleic acid fragments in urine are in development for bladder cancer . Abbot Laboratories ’ UroVysion uses this method with FISH analysis to identify specific epigenetic alterations consistent with bladder cancer . The combination of symptoms and these translocations are highly predictive of bladder cancer . Despite using new molecular structures to identify cancer , existing technologies will require infrastructure upgrades . For example , FISH will require automated , large-volume processing – which is in development by Ikonisys .
Table 9 : Bladder non-invasive tests Company |
Product |
Method |
Abbott Laboratories |
Alere NMP22
BladderCheck
|
NMP22 – protein-based biomarker |
Abbott Laboratories |
UroVysion |
Liquid biopsy – CtDNA |
Anchordx Corp . |
UriFind |
Liquid biopsy – CtDNA methylation |
Arocell Ab |
UBC |
Cytokeratin 8 + 18- protein-based biomarker |
Genomictree Inc . |
EarlyTect Bladder |
Liquid biopsy – CtDNA methylation |
Nucleix Ltd |
Bladder EpiCheck |
Liquid biopsy – CtDNA methylation |
Pacific Edge |
Cxbladder |
mRNA |
Source : goetzpartners Research , BioCentury Inc .
Figure
13 : Liquid biopsy companies
Early
diagnosis market overview
The early diagnosis market is increasing with demand , Grail estimates the screening of high-risk patients could generate $ 20bn - $ 40bn p . a . rising to $ 100bn - $ 200bn if screening of healthy individuals were included . The market potential continues to fuel investment in the space . The largest deal is Illumina ’ s acquisition of their own spinout Grail for a panel MCED test worth $ 8bn . Increasingly , companies are investing in these types of screening tests rather than the companion diagnostic usage of liquid biopsies . Exact Sciences acquired the Thrive Earlier Detection for their CancerSEEK liquid biopsy programme for $ 2.15bn in 2020 . Grail ’ s revenue of $ 12m in 2021 suggest these acquisitions are currently overvalued against a backdrop of $ 931m in expenses it is clear this will take time to be rewarded .
Figure 14 : Early diagnosis market potential
All-risk patients ( 390m )
$ 100bn - $ 200bn
Source : goetzpartners Research
Large Pure
Addressable market
$ 20bn - $ 40bn
High-risk patients ( 70m )
Base case Bull case
Source : goetzpartners Research , Grail
Please see analyst certifications , important disclosure information , and information regarding the status of analysts on pages 91-94 of this research report .