Performance Data

GALEAS™ Bladder accurately detects somatic mutations present in over 96% of bladder cancer cases and has been validated using 770 urine samples from three UK clinical cohorts.

	Sensitivity	Specificity	NPV
pTa	86%	86%	93%
T1	95%	86%	99%
T2+	89%	86%	97%
G1	76%	86%	96%
G2	92%	86%	97%
G3	92%	86%	95
NMIBC	89%	86%	92%
MIBC	89%	86%	97%

GALEAS^TM Bladder

NMIBC

Sensitivity: 89%

Specificity: 86%

NPV 92: %

GALEAS^TM Bladder

MIBC

Sensitivity: 89%

Specificity: 86%

NPV: 97%

Cystoscopy ^(1,2)

Sensitivity: 84%

Specificity: 86%

NPV: 96%

GALEAS™ Bladder Intervention Opportunities: Hematuria Triage

Each year, hundreds of thousands of patients with hematuria are referred to medical institutions for cystoscopy to confirm the presence or absence of cancer. However, only about 10% of these referrals result in a bladder cancer diagnosis. This means that hundreds of thousands of patients undergo unnecessary, painful, and invasive procedures, leading to substantial medical costs.

GALEAS™ Bladder offers a non-invasive molecular triage for hematuria patients, enabling rapid and accurate detection of bladder cancer to streamline diagnosis. This test has been validated with urine samples from over 700 patients, demonstrating high performance across all stages and grades of bladder cancer ^{(1, 2)}.

Reporting

• A positive/negative report is sent to the urologist,
• Details of somatic variants identified are provided

Cloud-based GALEAS™ Analysis Software

The cloud-based GALEAS™ analysis software provides simple positive or negative results.

Urologist requests a urine collection device for patient

Patient sends barcoded urine sample to service laboratory

Lab uploads sequencing results to secure cloud-based GALEAS platform

Results analyzed, report generated and shared directly with urologist

Urologist shares results with patient and discusses next steps

References

1.  Zhu, C. Z., Ting, H. N., Ng, K. H., & Ong, T. A. (2019). A review on the accuracy of bladder cancer detection methods. Journal of cancer, 10(17), 4038. Full article

2. Alimi, Q., Hascoet, J., Manunta, A., Kammerer‐Jacquet, S. F., Verhoest, G., Brochard, C., … & Peyronnet, B. (2018). Reliability of urinary cytology and cystoscopy for the screening and diagnosis of bladder cancer in patients with neurogenic bladder: a systematic review. Neurourology and Urodynamics, 37(3), 916-925. Full article

3. Ward et al. BJU Int. 2019, Targeted deep sequencing of urothelial bladder cancers and associated urinary DNA: a 23-gene panel with utility for non-invasive diagnosis and risk stratification

3. Ward DG, Gordon NS, Boucher RH, et al. Targeted deep sequencing of urothelial bladder cancers and associated urinary DNA: a 23-gene panel with utility for non-invasive diagnosis and risk stratification. BJU Int. 2019;124(3):532-544. doi:10.1111/BJU.14808. Full article