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▎WuXi AppTec Content Team Editor Today, Benchmark Medical announced the launch of a registered clinical trial of its bladder cancer early detection product UriFind in the United States, and has completed the enrollment of the first patient, hoping to promote the research and development process of this product to achieve early diagnosis
of bladder cancer.
The clinical trial is designed to validate the performance of the product, and the results will be submitted to the U.
S.
FDA for premarket approval
.
Bladder cancer is a common tumor with a high recurrence rate, and the vast majority of bladder cancer cases (>90%) are urothelial cancers
.
According to statistics, the number of new cases of bladder cancer in the United States in 2021 was as high as 84,000, and the number of deaths was about 17,300, which brought a heavy burden
to society and patients' families.
At this stage, cystoscopy combined with pathological biopsy is the gold standard for diagnosing new and recurrent bladder cancer, but because it is an invasive detection method, it is not conducive to long-term follow-up detection and large-scale population screening of bladder cancer; On the other hand, urinary exfoliative cytology and other existing non-invasive detection methods are inferior to cystoscopy and cannot be used as an effective means
of bladder cancer detection.
In response to this problem, Benchmark Medical has made great efforts in the field of cancer early detection and successfully developed UriFind
, an innovative detection tool for bladder cancer.
Founded in 2015, Benchmark Medical is a company that uses methylation high-throughput sequencing for early screening and early diagnosis of cancer products, one of its main innovative products, UriFind, is a non-invasive early detection product for bladder cancer, which has the characteristics of painless, non-invasive and easy to operate, only need the subject to provide urine, through the methylation detection of exfoliated cell DNA in the urine, can accurately detect bladder cancer
。 As an innovative detection tool, UriFind is not only comparable in performance to cystoscopy, but also shows superior performance over traditional detection methods such as exfoliative cytology in terms of detection sensitivity and specificity, especially in the detection of early, micro, residual and recurrent bladder cancer, which is expected to provide better solutions
for the clinical diagnosis of bladder cancer.
As early as July 2021, UriFind was granted the "Breakthrough Medical Device" designation by the US FDA, and was granted the qualification
for rapid review of future US registration applications and product launches.
"In order to better evaluate and solve the clinical pain points in the early detection and diagnosis of cancer, we spare no effort to verify the performance of the developed products through a large number of rigorous clinical trials, in order to advance advanced cancer detection technology into clinical practice
.
" We are working with many of the world's leading urologists to obtain important data
that fully demonstrates the clinical value of UriFind.
The launch of UriFind's U.
S.
registered clinical trial also marks an important step
on the road to overseas commercialization of benchmark medical cancer early detection products.
Dr.
Jianbing Fan, founder and CEO of Benchmark Healthcare, said
in the press release.
Dr.
Marina Bibikova, Chief Scientific Officer of Benchmark Healthcare, said, "The UriFind bladder cancer detection clinical study is the first clinical trial
initiated by Baseline Medical in the United States.
We have developed this high-performance product for the detection of bladder cancer based on our self-developed DNA methylation detection technology, and we are very excited about this breakthrough technology to improve the diagnosis and treatment of
patients.
"
It is understood that UriFind has completed a registered clinical trial in China and obtained the priority review qualification of the National Medical Products Administration (NMPA) in August 2022 because it "diagnoses or treats malignant tumors and has obvious clinical advantages"; Prior to this, it also obtained the EU CE certification
.
The launch of this registered clinical trial marks another step forward for UriFind in seeking regulatory approval, and we look forward to the launch of this product to benefit more patients with bladder cancer with early detection and early treatment to improve survival
.
"
WuXi AppTec provides integrated, end-to-end new drug development and manufacturing services to the global biopharmaceutical industry, covering chemical drug development and manufacturing, biological research, preclinical testing and clinical trial development, cell and gene therapy development, testing and manufacturing
.
If you have relevant business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please press and hold to scan the QR code above, or
of bladder cancer.
The clinical trial is designed to validate the performance of the product, and the results will be submitted to the U.
S.
FDA for premarket approval
.
Bladder cancer is a common tumor with a high recurrence rate, and the vast majority of bladder cancer cases (>90%) are urothelial cancers
.
According to statistics, the number of new cases of bladder cancer in the United States in 2021 was as high as 84,000, and the number of deaths was about 17,300, which brought a heavy burden
to society and patients' families.
At this stage, cystoscopy combined with pathological biopsy is the gold standard for diagnosing new and recurrent bladder cancer, but because it is an invasive detection method, it is not conducive to long-term follow-up detection and large-scale population screening of bladder cancer; On the other hand, urinary exfoliative cytology and other existing non-invasive detection methods are inferior to cystoscopy and cannot be used as an effective means
of bladder cancer detection.
In response to this problem, Benchmark Medical has made great efforts in the field of cancer early detection and successfully developed UriFind
, an innovative detection tool for bladder cancer.
Founded in 2015, Benchmark Medical is a company that uses methylation high-throughput sequencing for early screening and early diagnosis of cancer products, one of its main innovative products, UriFind, is a non-invasive early detection product for bladder cancer, which has the characteristics of painless, non-invasive and easy to operate, only need the subject to provide urine, through the methylation detection of exfoliated cell DNA in the urine, can accurately detect bladder cancer
。 As an innovative detection tool, UriFind is not only comparable in performance to cystoscopy, but also shows superior performance over traditional detection methods such as exfoliative cytology in terms of detection sensitivity and specificity, especially in the detection of early, micro, residual and recurrent bladder cancer, which is expected to provide better solutions
for the clinical diagnosis of bladder cancer.
As early as July 2021, UriFind was granted the "Breakthrough Medical Device" designation by the US FDA, and was granted the qualification
for rapid review of future US registration applications and product launches.
"In order to better evaluate and solve the clinical pain points in the early detection and diagnosis of cancer, we spare no effort to verify the performance of the developed products through a large number of rigorous clinical trials, in order to advance advanced cancer detection technology into clinical practice
.
" We are working with many of the world's leading urologists to obtain important data
that fully demonstrates the clinical value of UriFind.
The launch of UriFind's U.
S.
registered clinical trial also marks an important step
on the road to overseas commercialization of benchmark medical cancer early detection products.
Dr.
Jianbing Fan, founder and CEO of Benchmark Healthcare, said
in the press release.
Dr.
Marina Bibikova, Chief Scientific Officer of Benchmark Healthcare, said, "The UriFind bladder cancer detection clinical study is the first clinical trial
initiated by Baseline Medical in the United States.
We have developed this high-performance product for the detection of bladder cancer based on our self-developed DNA methylation detection technology, and we are very excited about this breakthrough technology to improve the diagnosis and treatment of
patients.
"
It is understood that UriFind has completed a registered clinical trial in China and obtained the priority review qualification of the National Medical Products Administration (NMPA) in August 2022 because it "diagnoses or treats malignant tumors and has obvious clinical advantages"; Prior to this, it also obtained the EU CE certification
.
The launch of this registered clinical trial marks another step forward for UriFind in seeking regulatory approval, and we look forward to the launch of this product to benefit more patients with bladder cancer with early detection and early treatment to improve survival
.
"
WuXi AppTec provides integrated, end-to-end new drug development and manufacturing services to the global biopharmaceutical industry, covering chemical drug development and manufacturing, biological research, preclinical testing and clinical trial development, cell and gene therapy development, testing and manufacturing
.
If you have relevant business needs, please click the picture below to fill in the specific information
.
▲If you have any business needs, please press and hold to scan the QR code above, or
