Bladder Cancer is the sixth most common cancer* diagnosed in the United States. According to the American Cancer Society, 82,290 new cases of the disease will be diagnosed in in 2023, while 16,710 patients are expected to die of bladder cancer. [1][2]

The most common form of bladder cancer, also known as urothelial carcinoma or  transitional cell carcinoma (TCC), start in the urothelial cells that line the inside of the bladder. Other types of bladder cancer, including squamous cell carcinoma (1% – 2%), adenocarcinoma (1%), small cell carcinoma (less than 1%) and sarcoma (less than 1%).[2]

One of the most common risk factors for bladder cancer is cigarette smoking.[3] Approximately half of all bladder cancers are caused by cigarette smoking, and evidence shows that cigarette smoking increases a person’s risk of bladder cancer two to four times above baseline risk (the increased risk estimated for a duration of less than 10 years with an odds ratio (OR) = 1.9, 95% confidence interval (CI) 1.1-3.1) to over a four-fold increased risk for a duration of greater than 40 years (OR = 4.1, 95% CI 3.0-5.5). [4]

Early diagnosis
In most cases, bladder cancer start in the innermost lining of the bladder, known as the urothelium or transitional epithelium. As the cancer grows into or through the deeper layers in the bladder wall, it becomes more advanced, and, in most cases is harder to treat. In the early stages of the disease, when bladder cancer is in the transitional epithelium, the disease is generally referred to as carcinoma in situ (stage 0). However, over time, when the cancer grows into the deeper layers of the bladder wall, the disease, now known as ‘invasive’ is more likely to metastizes, which makes treatment more challenging.

To improve treatment options, early diagnosis of bladder cancer remains important. However, today, there is no recommend routine screening of the general public there are  no screening test have been shown to lower the risk of dying from bladder cancer in people who are at average risk.

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Early signs
The most common sign of bladder cancer is hematuria. However, about 10 percent of visible hematuria patients and only 2% – 5% percent with microscopic hematuria are diagnosed with bladder cancer.

A new device may change that.  This week, the US Food and Drug Administration (FDA) granted Breakthrough Device Designation to EarlyTect BCD, a non-invasive, urine-based diagnosis of bladder cancer test for people suspected of having bladder cancer. The new test is being developed by Promis Diagnostics.

The EarlyTect BCD test is intended for qualitatively detecting a single epigenetic biomarker, PENK methylation, associated with bladder cancer in the urine DNA from patients with hematuria. Methylation of PENK is known to present highly frequently in the urine DNA of all patients with bladder cancers, while rarely or not at all in hematuria patients without the disease.

“We are very excited about this FDA’s Breakthrough Device Designation grant to the EarlyTect BCD. It is a testament to our relentless commitment to developing an effective diagnostic test. EarlyTect BCD would provide a meaningful improvement in non-invasive diagnostics addressing unmet needs of catching primary cancer early in the initial diagnosis. Consequently, it will improve patient outcomes.,” explained Sungwhan An, Ph.D., CEO.

Expediting review
Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions. To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment, and review while maintaining regulatory standards for pre-market approval.

“We look forward to working with the FDA to accelerate the approval process and to get EarlyTect BCD into the hands of patients and healthcare providers faster,” concluded Justin Lee, Head of Business Strategy & Operations at Promis Diagnostics.

Note: * Based on data from the American Cancer Society, bladder cancer is the fourth most common cancer in men and the eleventh most common cancer in women.

[1] American Cancer Society: Cancer Facts and Figures 2023. American Cancer Society, 2023. Available onlineExit Disclaimer. Online. Last accessed on April 27, 2023.
[2] What is Bladder Cancer. American Cancer Society. Online. Last accesses on April 27, 2023
[3] Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25. PMID: 22877502.
[4] Brennan P, Bogillot O, Greiser E, Chang-Claude J, Wahrendorf  20, Cordier S, Jöckel KH, Lopez-Abente G, Tzonou A, Vineis P, Donato F, Hours M, Serra C, Bolm-Audorff U, Schill W, Kogevinas M, Boffetta P. The contribution of cigarette smoking to bladder cancer in women (pooled European data). Cancer Causes Control. 2001 Jun;12(5):411-7. doi: 10.1023/a:1011214222810. PMID: 11545456.
[5] Kirkali Z, Chan T, Manoharan M, Algaba F, Busch C, Cheng L, Kiemeney L, Kriegmair M, Montironi R, Murphy WM, Sesterhenn IA, Tachibana M, Weider J. Bladder cancer: epidemiology, staging and grading, and diagnosis. Urology. 2005 Dec;66(6 Suppl 1):4-34. doi: 10.1016/j.urology.2005.07.062. PMID: 16399414.

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