urifind®️-最新凯时注册

dna methylation product for non-invasive urothelial carcinoma (uc) early detection test.

disease background

urothelial carcinoma(uc) iscancer that begins in the urothelial cells, which line the urethra, bladder, ureters, renal pelvis, and some other organs. almost all bladder cancers are urothelial carcinomas. in addition, uc also includes upper tract urothelia

high incidence:bladder cancer is the most prevalent tumor of the urinary system. the number of new cases is more than 80,000 and the number of deaths is more than 30,000.
high mortality: mri index of men’s bladder cancer is 0.40 (mortality/incidence) ,which higher than other tumor.
high recurrence rate: the 5-year recurrence rate of non-muscular invasive bladder cancer (nmibc) is as high as 60-78%; the recurrence rate of upper urinary tract urothelial carcinoma (utuc) is 22%-47%^[1].
high treatment cost: the cost of treating bladder cancer by medical insurance ranks top 4 cancers^[2].

the traditional technology has many limitations in the diagnosis of bladder cancer

ultrasound imaging: sensitivity 63-98%, dependence on physician experience, and inability to diagnose carcinoma in situ.
urinary tumor marker: low specificity, and susceptibility to hematuria interference.
urine cytology: sensitivity 13-75%, difficulty in detecting lg-uc, and inability to exclude diagnosis based on a negative result.
fluorescence in situ hybridization (fish): low throughput, complex operation, and dependence on pathologist experience.
cystoscopy tissue biopsy: liability to overlooking carcinoma in situ, invasive examination, and poor compliance of the patients of postoperative review.

product advantages

87.4
%

sensitivity
91.5
%

specificity
89.3
%

accuracy

accurate performance

accuracy 89.3%, equivalent to gold standard: cystoscopy.
painless and convenient

just 100ml of random urine needs to be collected for testing. it is more comfortable.
proprietary patent

the detection method was granted with a chinese invention patent (patent no. zl2019 1 1370095.5).
professional recognition

verification and use experience of large clinical studies in hundreds of grade-a tertiary hospitals. the detection method and performance were published on professional medical journals the journal of clinical investigation and clinical epigenetics.

it has been recognized at home and abroad

fda certification

urifind^® earns "breakthrough device designation" (btd) from was identified as a breakthrough device (btd) by u.s. food and drug administration the breakthrough technology has significant advantages and is in the best interest of patients compared with the existing products.
ce certification

urifind^® obtained european access permit for in-vitro diagnostics devices (ivdd) authorized by the netherlands cibg
urifind^® was admitted to china's national medical products administration (nmpa) priority review pathway known as the "green channel"

the product was approved as a medical device with priority by nmpa in august 2022. nmpa believes the product is a medical device used for “diagnosing or treating malignant tumors and having obvious clinical advantages”.
inclusion in guidelines

urifind^tmwas included in the chinese guidelines for diagnosis and treatment of urological and andrological diseases (2022)

awards & honors

first prize for science and technology progress in guangdong province in 2021
awards & honors

guangdong famous high-tech product

target users

it is suitable for the auxiliary diagnosis of the patients who have hematuria and/or bladder irritation, or are advised by doctor to undertake cystoscopy.

sample collection and service process

sample collection

100ml of urine

service process

test counseling
sample collection
sample transport
testing and analysis
report issuance
after-sales service

references

[1] guidelines for diagnosis and treatment of bladder cancer (2018). gwbyh [2018] 1125.
[2] china statistical yearbook of health and family planning (2020).
[3] j clin invest. 2020 dec 1;130(12):6278-6289.
[4] clin epigenetics. 2021 apr 26;13(1):91.